Bio Screening Industry News

Labcyte announced the introduction of the latest member of its acoustic dispensing family, the Echo® 520 liquid handler, which was developed for the medium-throughput laboratory. The 520 system provides high accuracy and precision transfers of a wide variety of solutions at an appropriate price for the laboratory that needs to transfer as many as 100,000 solutions per day. Like other Labcyte Echo liquid handlers, the Echo 520 improves data quality by avoiding loss of sample by adsorption onto tips and intermediate plates. This system uses the same acoustic droplet ejection (ADE) technology that has enabled the leading pharmaceutical companies to reduce the volume of their assays while obtaining more reliable data. The rapid ejection of 2.5 nL droplets facilitates the use of 96-, 384-, 1536- and 3456-well assay plates.

“The Echo 520 liquid handler will bring our ADE technology to a wider number of users,” said CEO, Dr. Elaine J. Heron. “This new addition to the product line provides the best-in-the-industry precision and accuracy at a lower price. The Echo 520 is fully compatible with Labcyte software for cherry picking and setting up flexible dose-response assay plates. It, like the 550 and 555 systems, is immediately and fully compatible with lab automation.

“This new product makes the advantages of ADE accessible to the laboratory which could not afford and did not need the high throughput of our 550 and 555 systems. And these laboratories can feel comfortable knowing that if their throughput needs increase, they can upgrade the 520 to higher throughput versions,” said Heron.

As the leader in acoustic droplet ejection, Labcyte offers direct support in North America, Europe and Japan for the Echo 520 and our other systems.  Additionally, the Labcyte software for cherry picking and flexible dose-response assays optimally exploits the many advantages of precise low nanoliter liquid transfer.  Like other Labcyte systems, the Echo 520 can be used to transfer a wide variety of common aqueous buffers used in protein and nucleic acid assays, as well as DMSO for drug compound management and screening

To see a video of acoustic droplet formation, please visit
http://www.labcyte.com/media/2nL.mpeg
Labcyte Inc., headquartered in Sunnyvale, California, is the world leader in providing acoustic droplet ejection technology for pharmaceutical and life science applications. The award-winning Echo 500 series liquid handlers and Portrait 630 reagent multi-spotters are used in nine of the 10 largest pharmaceutical companies, as well as in leading academic and research institutions and contract research organizations worldwide. The Labcyte acoustic droplet ejection technology has broad applications including compound management, assays, arraying, particle manufacturing, imaging mass spectrometry, and live-cell transfer. Labcyte also provides a range of unique microplate consumables. Labcyte has 29 issued U.S. patents, 3 issued European patents and additional international filings. For more information, visit www.labcyte.com

Gossypol:

• is a polyphenolic aldehyde that permeates cells and acts as an inhibitor for several dehydrogenase enzymes.
• is antimalarial being the selective inhibitor of Plasmodium falciparum (pfLDH over hLDHs), an essential enzyme for energy generation within malarial parasite.
• posesses proapoptotic properties, probably due to the regulation of the Bax and Bcl2.
• reversibly inhibits Calcineurin and binds to calmodulin.
• inhibits replication of the HIV-1 virus.
• an effective protein kinase C inhibitor.

Read more about Gossypol

NEWARK, Del., Oct. 2 /PRNewswire-FirstCall/ — Strategic Diagnostics Inc. — today announced the launch of a new internet based catalog of antibody reagents in support of oncology-based research and discovery. These high-quality reagents have all been manufactured utilizing SDI’s proprietary Genomic Antibody Technology(TM) and will carry the SEQer(TM) brand. The catalog is available at http://antibodies.sdix.com online.

The catalog has launched with an initial offering of over 200 affinity purified antibody reagents. The Company will supplement this with up to an additional 25 new reagents each week as it strives to become recognized as the fastest-growing site of high quality, leading edge reagents for cancer research.

“Standard antibody production technologies have not changed in more than 20 years,” commented Matthew H. Knight, the Company’s President and Chief Executive Officer. “The SEQer antibodies in this catalog represent a breakthrough in antibody production and deliver multiple high performance attributes that reduced time, effort and data variation in the laboratory. In addition, the process that produces these reagents is high throughput as evidenced by our initial commitment to add up to 25 new antibody reagents each week. As recognition of SEQer antibody performance grows, we intend to increase this rate.”

Mr. Knight continued, “The launch of the SEQer catalog is a direct response to market research highlighting how the Life Science industry and particularly proteomics research has been inhibited by to the lack of high quality antibody reagents. The National Cancer Institute convened the Proteomic Technologies Reagents Resource Workshop in December, 2005, to identify the cancer research community’s expressed needs for validated and well characterized affinity capture reagents, including antibodies, to advance proteomics research platforms for the prevention, early detection, treatment, and monitoring of cancer. Many of the available catalogs typically broker pre-made antibodies from multiple sources and fall well short of meeting the performance needs of today’s biomedical researchers. With the launch of the SEQer catalog, Strategic Diagnostics is taking the first step to address this research bottleneck and meet a surging demand. We expect to build the fastest-growing source of oncology-focused antibody reagents which represents a meaningful share of the highly fragmented, $800 million annual market for catalog reagents.”

Strategic Diagnostics’ Genomic Antibody Technology(TM) (GAT) platform

Genomic Antibody Technology(TM) is a proprietary technology developed by Strategic Diagnostics (SDI). This high throughput, sequence-based, in vivo production process creates high-quality poly- or monoclonal reagents used in the discovery of new diagnostic biomarkers, unraveling the underlying mechanisms of disease, and as the basis of potential monoclonal antibody therapeutics. These antibodies are produced in 76 days and early adopters have tracked a first-time success rate in excess of 80%. SDI’s proprietary protein analysis software selects the optimal sequence associated with the specific protein or protein region the researcher wants to target and/or avoid. GAT expresses protein in vivo, thus assuring that the antigen targets and fully engages the natural mammalian immune system. This enables the production of an antibody that reacts more often and with greater fidelity when compared to reagents produced through traditional methods.

The SEQer catalog of antibodies addresses a number of well-known challenges associated with currently available reagents. Specifically, deficiencies in the ability to replicate the three dimensional conformation of target proteins through synthetic immunogens have resulted in reagents that do not reliably recognize or differentiate their intended targets. This, in turn, limits reagent performance and creates a level of uncertainty regarding the data produced with traditionally produced reagents. The SEQer antibody is focused on addressing the loss of productivity in research and development endeavors.

“The performance of our SEQer antibodies has been demonstrated with our many private and public collaborators in numerous assays,” Mr. Knight said. “The programs have included significantly large screens for oncology markers and the ability to stain disease-associated proteins across thousands of clinical biopsy samples. More targeted studies have shown the ability to differentiate highly conserved proteins in cell sorting assays, the ability to react with traditionally elusive proteins of interest, and be directed through SDI’s design algorithms to target functional sites in monoclonal applications.”

SDI’s GAT-produced antibodies are significantly better than traditional protein/peptide-produced antibodies, as they are produced in vivo by the host animal’s natural immune system, and are therefore able to behave both chemically and mechanically as any naturally produced antibody would.

Oncology Focus

The SEQer oncology-focused portfolio is comprised of antibody tools that target proteins associated with cancer pathogenesis and progression, thereby succeeding in delivering usable data for more proteins and in more applications. SDI strategically focused on the area of oncology, as more than half of NIH-funded research and the majority of proteomic efforts are currently focused on cancer research.

“SDI is focused on the oncology segment of life science research and is committed to creating industry leading solutions for oncology research,” Mr. Knight added. “This initial offering is a powerful step in that direction. As we expand this catalog, it will become the premier site for new and important antibody reagents for cancer research.”

About Strategic Diagnostics, Inc.

Strategic Diagnostics Inc. develops, manufactures and markets biotechnology-based detection solutions to a diverse customer base, across multiple industrial and human health markets. By applying its core competency of creating custom antibodies to assay development, the Company produces unique, sophisticated diagnostic testing and reagent systems that are responsive to customer diagnostic and information needs. Customers benefit with quantifiable “return on investment” by reducing time, labor, and/or material costs. All this is accomplished while increasing accuracy, reliability and actionability of essential test results. The Company is focused on sustaining this competitive advantage by leveraging its expertise in immunology, proteomics, bio-luminescence and other bio-reactive technologies to continue its successful customer-focused research and development efforts. Recent innovations in high throughput production of antibodies from genetic antigens will complement the Company’s established leadership in commercial and custom antibody production for the Research, Human/Animal Diagnostics, and Pharmaceutical industries, and position the Company for broader participation in the pharmacogenomics market.

This news release contains forward-looking statements reflecting SDI’s current expectations. When used in this press release, the words “anticipate”, “could”, “enable”, “estimate”, “intend”, “expect”, “believe”, “potential”, “will”, “should”, “project” “plan” and similar expressions as they relate to SDI are intended to identify said forward-looking statements. Investors are cautioned that all forward-looking statements involve risks and uncertainties, which may cause actual results to differ from those anticipated by SDI at this time. Such risks and uncertainties include, without limitation, changes in demand for products, delays in product development, delays in market acceptance of new products, retention of customers and employees, adequate supply of raw materials, the successful integration and consolidation of the Maine production facilities, inability to obtain or delays in obtaining fourth party, including AOAC, or required government approvals, the ability to meet increased market demand, competition, protection of intellectual property, non-infringement of intellectual property, seasonality, and other factors more fully described in SDI’s public filings with the U.S. Securities and Exchange Commission.

ST. LOUIS, Oct. 18 /PRNewswire-FirstCall/ — Sigma-Aldrich announced today the global release of the N-TER(TM) Nanoparticle siRNA Transfection System. N-TER allows researchers to reproducibly interrogate gene function, via siRNA transfection, in model cell types that have previously not been considered amenable to conventional lipid-based siRNA delivery reagents.

“Traditional lipid-based siRNA transfection reagents exhibit a number of drawbacks, including high cell death rates and a limited ability to deliver siRNA into a variety of cell types, such as primary, neuronal, differentiated, and nondividing cells,” said Tim Fleming, Director of Global Commercial Marketing at Sigma-Aldrich. “Our goal is to introduce a reagent into the scientific community that effectively bypasses these historic limitations and enables siRNA transfection to be performed in a wider variety of model systems.”

The N-TER Nanoparticle siRNA Transfection System circumvents the limitations of lipid-based transfection reagents by relying on a stable nanoparticle, formed by the blending of siRNA and the N-TER peptide, to quickly enter into the cell’s cytoplasm to deliver its siRNA cargo.

In addition, due to the reagent’s stability, stocks of N-TER/siRNA Nanoparticles can be stored for long periods of time and used for subsequent transfections, increasing standardization and reproducibility in all transfection experiments targeting the same gene.

“Our research on the functions of West Nile Virus proteins involves looking at gene function in a number of different cell types,” said Dr. Tom C. Hobman, Professor of Cell Biology at the University of Alberta. “We tested a number of siRNA delivery reagents before using N-TER. Once we tried N-TER, we were very impressed with its ability to reproducibly deliver siRNA into our cell types of interest, with minimal cellular toxicity.”

For more information on the N-TER Nanoparticle siRNA Transfection System and to see the list of cell types in which N-TER has been proven to work, please visit http://www.sigma.com/nter.

About Sigma-Aldrich: Sigma-Aldrich is a leading Life Science and High Technology company. Our biochemical and organic chemical products and kits are used in scientific and genomic research, biotechnology, pharmaceutical development, the diagnosis of disease and as key components in pharmaceutical and other high technology manufacturing. We have customers in life science companies, university and government institutions, hospitals, and in industry. Over one million scientists and technologists use its products. Sigma-Aldrich operates in 36 countries and has 7,700 employees providing excellent service worldwide. We are committed to Accelerating Customer Success through Leadership in Life Science, High Technology and Service. For more information about Sigma-Aldrich, please visit our award-winning Web site at http://www.sigma-aldrich.com.

Cautionary Statement: This release contains forward-looking statements relating to future strategic actions and initiatives and similar intentions and beliefs and other statements regarding the Company’s expectations, beliefs, intentions and the like, which involve assumptions regarding the Company’s operations and conditions in the markets the Company serves. The Company does not undertake any obligation to update these forward-looking statements.

The miRNA QRT-PCR detection kit uses a proprietary miRNA primer design approach to detect mature miRNA from as little as 15 ng of input, down to 100 copies, in less than three hours. Optimized QPCR reagents provide single nucleotide discrimination within and among miRNA families. MicroRNAs (miRNAs) are small, non-coding RNA molecules that are estimated to regulate at least 30% of all protein encoding genes. miRNAs have been implicated in development, differentiation, apoptosis, viral infection, and cancer. miRNAs are difficult to analyze by traditional PCR approaches due to their small size of approximately 22 nucleotides.

Manufacturer: Stratagene

11011 N. Torrey Pines Rd.
La Jolla, CA, 92037
Website: http://www.stratagene.com

Stratagene is a leader in developing, marketing and manufacturing innovative life science consumables, instrumentation, and diagnostic products for a variety of human medical conditions. The company’s life science research operations support advances in science by inventing, manufacturing and distributing products that simplify, accelerate and improve research. These products are used throughout the academic, industrial, and government research sectors in fields spanning molecular biology, genomics, proteomics, drug discovery and toxicology. The company’s diagnostic operations develop and manufacture products include high-quality automated instrument and reagent systems that use blood samples to test for more than 1,000 different allergies and autoimmune disorders and urinalysis controls. More information is available at www.stratagene.com

— Acquisition of BioFocus completed, integration progresses as
planned

— Galapagos year to date revenues 8% below last year’s revenues,
but cash burn in line with forecast

— Revenue guidance for 4Q ‘05 of 7.7 million, full year cash burn
of 7 million

— Strong cash position of 25 million on Sept. 30, 2005

— Management further strengthened with appointment of David Smith
as CFO

— New partnerships underscore competitive position in services
business

— Promising in vivo data on proprietary drug discovery programs
reported

— Galapagos rheumatoid arthritis target validated

— Optimistic outlook for partnering deals and library sales in 4Q

MECHELEN, Belgium, Nov. 10, 2005 (PRIMEZONE) — Galapagos NV (Euronext:GLPG) (LSE:GLPG) today announced its financial results for the first nine months of 2005.

Total revenue for the first nine months of 2005 amounted to 3.3 million, compared to 3.6 million in the first nine months of 2004, due to a decrease in custom adenovirus orders delivered in this period. The net loss for the first half of 2005 increased to 5.7 million from 4.3 million in the same period last year, reflecting stepped up R&D program investment. Cash and cash equivalents amounted to 25.1 million on September 30, 2005. “We have had an exciting quarter with the acquisition of BioFocus. We also have seen good service revenues but a slower custom adenovirus business. With our order portfolio, we expect to recoup some of these sales in the fourth quarter. We are optimistic on closing further deals this quarter, especially as we now have a joint sales offering with BioFocus. Consolidating their activities, we can give revenue guidance of 7.7 million for the last quarter of 2005. We have taken adequate cost control measures in order to offset the slower-than-expected third quarter sales; consequently, we remain on track to meet our full year 2005 cash burn guidance of 7 million,” said Onno van de Stolpe, Galapagos’ CEO. “Having seen the first very promising in vivo data from our rheumatoid arthritis program, we are excited about the progress in our drug discovery programs and expect to move forward rapidly toward demonstrating our first in vivo proof of concept.”

Key figures for first nine months 2005

(thousand, except net loss per share)

Sept 30, 2005 Sept 30, 2004 % change

Revenue 3,292 3,586 -8%
Loss from operations -5,812 -4,356 33%
Finance income 106 9
Loss before taxes -5,706 -4,347 31%
Taxes 32 5
Net loss for the period -5,674 -4,341 30%
Basic loss per share (Eur) -0.75 -0.73
Cash and cash equivalents 25,113 9,522

Details of financial results for first nine months 2005

Note: Consolidation of BioFocus results will start on October 12, 2005, to be published in Galapagos’ Full Year 2005 Results on March 3, 2006.

Revenue

Galapagos’ revenues for the first nine months of 2005 amounted to 3.3 million, a decrease of 8% on the 3.6 million recorded in the same period of 2004. Galadeno service division revenues amounted to 1.7 million for the first nine months compared to 1.9 million for the same period in 2004. Government grants in the period were 1.6 million compared to 1.7 million in the same period last year.

The decrease in service division revenues compared to last year is the result of fewer deliveries in the custom adenovirus business. Deliveries are expected to increase in the fourth quarter, allowing us to recoup some of these revenues. Following the BioFocus acquisition, we have decided to review the merits of pursuing medicinal chemistry work on the Alzheimer program in-house, thereby increasing the value of these targets. We have therefore decided to delay the out-licensing of the Alzheimer program, which is likely to decrease our fourth quarter 2005 contract revenues compared to the same period last year. Guidance for consolidated revenues for fourth quarter 2005 is 7.7 million.

Results

The net loss for the first nine months of 2005 was 5.7 million, or 0.75 per share, an increase of 1.4 million from the 4.3 million, or 0.73 per share for the first nine months of 2004.

Total research and development expenses in the first nine months of 2005 were 4.8 million, compared to 3.9 million in the same period 2004. The additional investment in R&D programs includes additional chemistry on our product development, including stepped up outsourcing.

Selling, general and administrative expenses increased slightly to 3.2 million in the first nine months of 2005 when compared to the 3.0 million in the same period of 2004.

Cash flow and cash position

A net increase of 14.8 million in cash and cash equivalents was recorded during the first nine months of 2005 (25.1 million compared to 10.3 million at the end of 2004). Cash used in operations was 5.1 million, on track for this year’s projected cash burn of 7.0 million. Furthermore, total lease payments made and investments in equipment amounted to 0.8 million. Galapagos raised 22.4 million in a public offering priced at 7 per share, amounting to a net cash contribution of 20.7 million. Galapagos’ cash and cash equivalents amounted to 25.1 million on September 30, 2005.

Corporate highlights

— Acquisition of BioFocus plc completed

— Listing on the AiM London

— Management further strengthened

— U.S. patent protecting target discovery platform

— Boston sales office opened

In September 2005, Galapagos announced an all share offer for BioFocus plc in the U.K. The strategic rationale for the offer was that BioFocus’ expertise in chemistry, lead discovery and lead optimization will greatly accelerate the progress of Galapagos’ programs and assist in Galapagos’ transition to a fully integrated drug development biopharmaceutical company. Additionally, the Enlarged Group would be well positioned to provide a suite of complementary biology and chemistry services to a broad base of customers, offering turnkey projects from target discovery to lead delivery.

Galapagos’ offer for BioFocus became wholly unconditional on October 17, 2005. Galapagos shares were admitted to trading on the London Stock Exchange’s Alternative Investment Market (AiM) on October 20, 2005. On October 27, 2005, Galapagos announced that acceptances had been received for over 92% of the BioFocus shares, and the offer for BioFocus was closed.

Following the completion of the acquisition of BioFocus, a number of appointments were made. Chris Newton, previous Chief Operating Officer of BioFocus, and David Phillips, previous Chief Business Officer of BioFocus, have joined the Executive Committee of Galapagos as Senior VP BioFocus and Senior VP Sales and Marketing, respectively. Also as a result of the acquisition, Galapagos’ Board of Directors will be strengthened by Geoff McMillan, previous CEO of BioFocus and David Stone, previous Chairman of BioFocus, as non-executive Directors.

David Smith was appointed as Chief Financial Officer of Galapagos and will fulfill his role starting February 1, 2006. David joins from AstraZeneca Netherlands, where he was Chief Financial Officer.

Galapagos announced that its IP position was strengthened further by receiving its third U.S. patent for its target discovery platform. This patent protects the Company’s adenoviral gene knock-down (SilenceSelect(r)) and gene knock-in (FLeXSelect(r)) collections, the core of multiple target discovery deals with pharmaceutical and biotech companies as well as patient organizations.

Additionally, Galapagos has opened a sales office in Boston, U.S., as of November 1, to support its sales and marketing activities. This office is headed by Nathalie Joly, BioFocus’ Director Business Development, North America.

Operational highlights Partnering activities

— Chemical library supply and medicinal chemistry services deal
with Serono (Switzerland) (signed in fourth quarter)

— Target discovery alliance with High Q Foundation (U.S.) for
Huntington disease

— Research collaboration with Novartis Pharmaceuticals (U.K.)

— Research collaboration with Amsterdam Molecular Therapeutics,
Netherlands Institute for Brain Research and Vrije Universiteit
Amsterdam

— BioFocus product offering broadened with two new compound
libraries and increased ion channel screening capabilities.

Galapagos is optimistic regarding the opportunities to close further partnering deals and library sales in the remaining period of the year.

Integration

With the acquisition of BioFocus, the integration with Galapagos’ partnering unit Galadeno is underway, and the integrated services unit now operates under the BioFocus brand name. BioFocus provides reagents and gene-to-preclinical drug discovery services to a broad base of customers throughout the global pharmaceutical and biotechnology industries. Several deal synergies and cross selling opportunities to our complementary client bases were identified and are being pursued actively. Galapagos drug discovery

— First in vivo results in proprietary rheumatoid arthritis
program — proprietary target validated

— Drug discovery collaboration with ZoBio, Pyxis and Leiden
University, supported by Dutch government grant of 1.2
million

— Alzheimer targets move into proof of principle studies

Galapagos focuses on bone and joint diseases to build a pipeline of new chemical entities to treat these diseases. The company’s most advanced drug discovery program is in the area of rheumatoid arthritis and focuses on proprietary targets whose modulation significantly diminishes joint destruction and where the medicine has a clear benefit over existing therapies. The market for autoimmune diseases, including rheumatoid arthritis, currently exceeds 7 billion and is expected to grow to 14 billion in the next few years. Galapagos started its drug discovery program 14 months ago. The in vivo proof of concept study currently underway investigates how a compound developed against one of Galapagos’ proprietary targets reduces paw swelling in a well-established mouse arthritis model. Our results today show a significant a nd important reduction in disease causing cytokines such as TNF-alpha, providing the first in vivo validation of a Galapagos target for rheumatoid arthritis.

The collaboration with ZoBio, Pyxis Discovery and Leiden University, which was announced in August 2005 has enabled Galapagos to take advantage of cutting-edge drug discovery technology in the progression of one of its proprietary targets in arthritis. As part of the 1.2 million government grant for the collaboration, Galapagos receives 550k in support of this program.

As further support to out-licensing efforts, we will combine the required expertise of BioFocus in medicinal chemistry with our proprietary Alzheimer targets, thereby creating additional value for these targets.

Conference call and webcast presentation

Galapagos will conduct a conference call open to the public today at 09.30 Central European Time (CET), which will also be webcast. To participate in the conference call, please call +32 2290 1608 ten minutes prior to commencement. A question and answer session will follow the presentation of the results. The live audio webcast can be accessed via Galapagos’ website at www.glpg.com, and will be available for replay a few minutes after the live version airs.

About Galapagos

Galapagos is a publicly traded, genomics-based drug discovery company (Euronext Brussels: GLPG; Euronext Amsterdam: GLPGA, London AiM: GLPG) that has drug discovery programs based on proprietary, novel targets in the bone and joint diseases — osteoarthritis, osteoporosis and rheumatoid arthritis. Galapagos offers a full suite of target-to-drug discovery products and services to pharmaceutical and biotech companies through its division BioFocus, encompassing target discovery and validation, and drug discovery services through to delivery of pre-clinical candidates. In addition, BioFocus provides adenoviral reagents for rapid identification and validation of novel drug targets and compound libraries for screening. Galapagos currently employs 193 people, including 74 PhDs, and occupies facilities in Mechelen, Belgium, Saffron Walden, U.K. and Leiden, The Netherlands. The partners of Galapagos include Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Celgene, GlaxoSmithKline, Novartis, Organon, Serono, Vertex, and Wyeth. More information about Galapagos and BioFocus can be found at www.glpg.com.

CONTACT: Galapagos NV
Onno van de Stolpe, CEO
Tel: +31 6 2909 8028
ir@galapagos.be

Source: Galapagos Genomics

Following interest from its clients, Melbourn Scientific is extending the range of pharmacopoeial testing that it offers. Managing director Steve Westcott says that it is easy to calculate the benefits of outsourcing pharmacopoeial testing: ‘Pharmacopoeial testing requires specialist skills, it is the old school chemistry that is taught at few universities because it requires expensive reagents and an investment in specialist glassware and other equipment. ‘It is rarely economical for companies to retain people with these skills for the few occasions when the tests are needed.

‘We have found that our analysts enjoy the challenge of pharmacopoeial, which puts their skills to the test.

‘The methods are very exact and the reagents specific to a particular test makes it the equivalent of Delia Smith for the pharma world.

‘The skills required to make it work are not easy to pick up and our analysts have decades of accumulated experience to call upon and it gives them an opportunity to use them’.

Melbourn Scientific provides contract analytical services to the pharmaceutical industry, it is expanding its pharmacopoeial test facility and investing in the equipment and reagents required to run the full range of tests such as organic volatile impurities (OVIs), Kjeldahl nitrogen determination, sulphated ash, optical rotation and refractive index determinations.

Steve Westcott made the decision to expand the facilities in response to market demand.

‘A number of clients had requested pharmacopoeial testing and we made an investment to support this.

‘The natural progression was to build on this and offer a complete range of tests.

‘Response from clients has been enthusiastic and the staff are keen to take on the challenge’.

Melbourn Scientific says it has invested continually in the latest equipment.

The company employs about 40 analysts at its laboratories and has grown organically to provide a range of contract analytical services to the pharmaceutical industry.

Source: Melbourn Scientific

In-house and External Retrospective Research Studies Incorporating ProEx C
Biomarkers Presented at 53rd Annual Scientific Meeting of the American Society
of Cytopathology

BURLINGTON, N.C., Nov. 7 /PRNewswire-FirstCall/ — TriPath Imaging, Inc.
(Nasdaq: TPTH) today announced that the results of a new in-house
retrospective research study demonstrated that testing of cervical cytology
specimens with Research Use Only (RUO) reagents incorporating the Company’s
proprietary ProEx C biomarkers yielded a 93% (p<0.0001) improvement in
sensitivity for detection of biopsy evidence of high grade cervical
intraepithelial neoplasia (CIN2+) when compared to a high grade abnormal
cytology classification of HSIL+. The results of this retrospective research
study also demonstrated a 65% improvement in calculated Positive Predictive
Value for detection of CIN2+ when compared to all atypical and abnormal
cytology classifications combined, defined as ASCUS and higher (ASCUS+).
These and other data relating to the performance of the ProEx C biomarkers
as well as an array of clinical and research studies incorporating the
SurePath liquid based Pap test were presented at the 53rd Annual Scientific
Meeting of the American Society of Cytopathology (ASC) in San Diego,
California. In conjunction with the meeting, the Company is also sponsoring
two symposia entitled “A New Era in Cervical Cytology: Revealing Clues from
the Cell-Cycle” and “Molecular Technology for the Cytology Lab: Initial
Impressions of In-House Use of ProEx C”.

Data from In-House Research Is Consistent with Previously Reported
External Research Studies
In a platform presentation made to the plenary session of the ASC meeting,
Adriann Taylor, Director of Product Development at TriPath Oncology, discussed
the results of a new in-house research study that was designed to evaluate the
performance of RUO reagents incorporating ProEx C biomarkers in a
retrospective study of 1,600 cervical cytology specimens collected using the
SurePath test pack. This retrospective cohort included 939 specimens that had
been classified as atypical or abnormal (ASCUS+) by standard microscopic
examination. For the purpose of this retrospective research study, the ProEx
C biomarkers were incorporated into RUO reagents designed to cytochemically
distinguish the presence of the over-expression of proteins associated with
aberrant S-phase induction in cervical smears that have been classified as
atypical or abnormal according to the generally accepted Bethesda 2001 System
for classification of cytologic morphology.
In this pre-clinical research study, the sensitivity of testing with RUO
reagents incorporating the ProEx C biomarkers for detection of biopsy evidence
of CIN2+ was 96.2%, a 93% improvement (p<0.0001) when compared to
classification of HSIL+ by microscopic examination. The calculated Positive
Predictive Value (PPV) for biopsy-confirmed CIN2+ reflected a 65% improvement
in the PPV when compared to microscopic examination.
These data are consistent with the results of external retrospective
research studies that were presented in September at the European Congress of
Cytology in Paris. In these retrospective studies from the Johns Hopkins
Medical Institutions and the Massachusetts General Hospital, the results
demonstrated an improvement of 70.6% and 95%, (p=0.0015, p=0.0002),
respectively, in sensitivity for detection of biopsy evidence of CIN2+ and an
improvement of calculated Positive Predictive Value of 113% and 136%,
respectively, when compared to microscopic examination.
“The results of our relatively large retrospective study with RUO reagents
incorporating the ProEx C biomarkers are wholly consistent with previously
reported results,” said Johnny Powers, PhD., Senior Vice President, TriPath
Oncology. “These research studies further demonstrate the correlation between
detection of aberrant S-phase induction with our ProEx C biomarkers and biopsy
evidence of high grade cervical disease.”

External and In-House Research Studies Address Analytical Performance,
Workflow, Impact on Microscopic Examination, and Specific Biomarker
Performance
In addition to the large retrospective in-house study, six additional
studies were presented at the ASC meeting. Investigators from the Johns
Hopkins Medical Institutions and the University of Colorado reported virtually
no variability with regard to scoring and staining reproducibility when using
a “home brew” version of the ProEx C Analyte Specific Reagent (ASR). These
researchers further concluded that their “home brew” assays were unaffected by
routine laboratory environment factors in these studies. In a separate study,
investigators from Johns Hopkins Medical Institutions observed that testing
with the ProEx C biomarkers may assist with the detection of cytologic
abnormalities on microscopic examination. Studies from the Company’s in-house
research staff addressed assay automation and the performance of specific
constituent biomarkers.
“We are very pleased with the results of these very practical studies,”
said Timothy Fischer, TriPath Imaging’s Vice President of Product Development.
“These studies provide early validation of our efforts to develop a product
that will be robust, easy to use and can be readily introduced into the
routine laboratory setting. Analytical performance and adaptability to routine
laboratory workflow will be critical determinants of the commercial success of
our products.”

About the ProEx C Biomarkers
The ProEx C biomarkers are monoclonal antibodies that detect over-
expression of proteins that is associated with aberrant S-phase induction, an
abnormal growth state that has been associated with cancer of the cervix,
esophagus, skin, prostate, ovary and colon. These biomarkers were identified
as the result of an outcome driven gene discovery analysis of cervical
neoplasia that was completed in 2003.

Analyst Day
Immediately following its third quarter earnings conference call on
November 10th, the Company will host an Analyst Day conference in New York
City. Management will review the results of research studies employing the
Company’s ProEx C molecular markers that were presented in conjunction with
the October meeting of the European Congress of Cytology in Paris and the
November meeting of the American Society of Cytopathology in San Diego. This
review will include the results of studies performed by investigators from
three major academic centers as well as the results of new in-house research
studies. The Company will also review the potential clinical and commercial
value of its developing pipeline in the area of molecular diagnostic products
and imaging systems.

TriPath Imaging, Inc., headquartered in Burlington, North Carolina,
develops, manufactures, markets and sells innovative solutions to improve the
clinical management of cancer, including detection, diagnosis, staging and
treatment. TriPath Oncology, a wholly owned subsidiary of TriPath Imaging,
develops molecular diagnostic products for malignant melanoma and cancers of
the cervix, breast, ovary and prostate. For more information on TriPath
Imaging please visit our web site at http://www.tripathimaging.com.

Investors are cautioned that statements in this press release that are not
strictly historical statements constitute forward-looking statements which
involve risks and uncertainties that could cause actual results and outcomes
to differ materially from what is expressed in those forward-looking
statements. Such forward-looking statements include, without limitation, those
related to the development of the ProEx C biomarker and the analyte specific
reagent for detection of aberrant S phase induction. Important factors that
may affect such forward-looking statements include, without limitation:
TriPath Oncology may be unable to successfully develop and commercialize
products and services when anticipated, if at all; clinical trials may yield
results for product candidates incorporating the ProEx C biomarkers that
differ from the results of our in-house and external research studies; TriPath
Imaging’s products may not achieve or maintain market acceptance to the degree
anticipated; TriPath Imaging and TriPath Oncology’s products may not receive
FDA or other required regulatory approval when expected, if at all; and other
risks detailed in TriPath Imaging’s filings with the Securities and Exchange
Commission, including those described in TriPath Imaging’s Annual Report on
Form 10-K for the year ended December 31, 2004.

Contact
Stephen P. Hall, Chief Financial Officer
TriPath Imaging
336-290-8721

Power SYBR Sets a New Standard of Quality and Performance for Real-Time PCR Using SYBR Green Dye

FOSTER CITY, Calif. & SALT LAKE CITY–(BUSINESS WIRE)–Oct 26, 2005 - Applied Biosystems (NYSE:ABI), an Applera Corporation business, today announced the launch of Power SYBR(R) Green PCR Master Mix, a new line of reagents for real-time PCR gene expression applications.

SYBR(R) Green dye binds to any double stranded DNA molecule, offering a flexible and easy to use labeling method for real-time PCR.

“Power SYBR(R) Green PCR master mix is the next generation in SYBR-based real-time technology, providing researchers a cost effective and reliable chemistry with enhanced sensitivity for gene expression analysis, gene detection, and quantitation,” said Peter M. Dansky, Vice President and General Manager, PCR Consumables Business, Applied Biosystems. “This product introduction enhances our product portfolio for real-time PCR applications and is part of our larger strategy to grow our consumables business.”

Applied Biosystems Power SYBR(R) Green PCR Master Mix offers improved sensitivity through a newly optimized formulation. Power SYBR(R) Green PCR Master Mix minimizes variation and ensures consistent experimental results. Extensive validation studies were conducted to demonstrate enhanced sensitivity down to two copies per target.

“While TaqMan(R) chemistry is considered the gold standard platform for gene expression applications requiring high sensitivity and specificity, Applied Biosystems Power SYBR(R) Green reagents offer comparable sensitivity, but at lower cost, for researchers who opt to use SYBR(R) Green for specific applications, such as initial screening, target validation, or rapid assay development,” added Dansky.

Power SYBR(R) Green PCR Master Mix replaces the SYBR(R) Green PCR Master Mix in existing Applied Biosystems protocols using the same reaction preparation and thermal cycling conditions. Applied Biosystems offers a complete application solution for gene expression analysis, including an integrated suite of consumables and instruments, such as the Applied Biosystems Expression Array System, the Nucleic Acid PrepStation, TaqMan(R) Genomic Assays, TaqMan(R) Low Density Arrays, Real-Time PCR systems, primer and probe sets, reagents, disposables and software.

About Applera Corporation and Applied Biosystems

Applera Corporation consists of two operating groups. The Applied Biosystems Group serves the life science industry and research community by developing and marketing instrument-based systems, consumables, software, and services. Customers use these tools to analyze nucleic acids (DNA and RNA), small molecules, and proteins to make scientific discoveries and develop new pharmaceuticals. Applied Biosystems’ products also serve the needs of some markets outside of life science research, which we refer to as “applied markets,” such as the fields of: human identity testing (forensic and paternity testing); biosecurity, which refers to products needed in response to the threat of biological terrorism and other malicious, accidental, and natural biological dangers; and quality and safety testing, for example in food and the environment. Applied Biosystems is headquartered in Foster City, CA, and reported sales of nearly $1.8 billion during fiscal 2005. The Celera Genomics Group (NYSE:CRA) is engaged principally in the discovery and development of targeted therapeutics for cancer, autoimmune and inflammatory diseases. Celera Genomics is leveraging its proteomic, bioinformatic, and genomic capabilities to identify and validate drug targets, and to discover and develop small molecule therapeutics. It is also seeking to advance therapeutic antibody and selected small molecule drug programs in collaboration with global technology and market leaders. Celera Diagnostics, a 50/50 joint venture between Applied Biosystems and Celera Genomics, is focused on discovery, development, and commercialization of diagnostic products. Information about Applera Corporation, including reports and other information filed by the company with the Securities and Exchange Commission, is available at http://www.applera.com, or by telephoning 800-762-6923. Information about Applied Biosystems is available at http://www.appliedbiosystems.com/.

Applied Biosystems Forward-Looking Statements

Certain statements in this press release are forward-looking. These may be identified by the use of forward-looking words or phrases such as “should” among others. These forward-looking statements are based on Applera Corporation’s current expectations. The Private Securities Litigation Reform Act of 1995 provides a “safe harbor” for such forward-looking statements. In order to comply with the terms of the safe harbor, Applera Corporation notes that a variety of factors could cause actual results and experience to differ materially from the anticipated results or other expectations expressed in such forward-looking statements. These factors include but are not limited to (1) rapidly changing technology and dependence on the development and customer acceptance of new products; (2) sales dependent on customers’ capital spending policies and government-sponsored research; and (3) other factors that might be described from time to time in Applera Corporation’s filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Applera does not undertake any duty to update this information, including any forward-looking statements, unless required by law.

For Research Use Only. Not for use in diagnostic procedures.

NOTICE TO PURCHASER: LIMITED LICENSE

The PCR process, 5′ nuclease processes and dsDNA-binding dye processes are covered by patents owned by Roche and by patents owned by or licensed to Applera Corporation. Purchase of Power SYBR(R) Green PCR Master Mix is accompanied by a limited license to use it with detection by a dsDNA-binding dye as described in U.S. Patents Nos. 5,994,056 and 6,171,785 and corresponding patent claims outside the United States for the purchaser’s own internal research. No real-time apparatus or system patent rights or any other patent rights, and no right to use this product for any other purpose are conveyed expressly, by implication or by estoppel. This product is for research purposes only. Diagnostic uses require a separate license from Roche. Further information on purchasing licenses may be obtained by contacting the Director of Licensing, Applied Biosystems, 850 Lincoln Centre Drive, Foster City, California 94404, USA.

The SYBR(R) Green dye is sold pursuant to a limited license from Molecular Probes, Inc. under U.S. Patent No. 5,436,134 and 5,658,751 and corresponding foreign patents and patent applications.

Applied Biosystems is a registered trademark and Applera is a trademark of Applera Corporation or its subsidiaries in the US and/or certain other countries. TaqMan is a registered trademark of Roche Molecular Systems, Inc. SYBR is a registered trademark of Molecular Probes, Inc. Copyright(C) 2005. Applied Biosystems. All rights reserved.

Contact Applied Biosystems Sophie Patel, 650-554-2732 (Media) sophia.patel@appliedbiosystems.com Ana Kapor, 650-638-6227 (Investors) kapora1@appliedbiosystems.com