Bio Screening Industry News

Archive for the 'Cancer Research' Category

May 7, 2008

Invitrogen Scientists Link microRNA Sequences to Cancer Using RNA Samples from BioServe

Carlsbad, Calif., and Beltsville, Md., May 7, 2008 – In research demonstrating that RNA previously thought to have no biological relevance may be of use for therapeutic and diagnostic targets, Invitrogen Corporation (NASDAQ:IVGN), a provider of essential life science technologies for research, production and diagnostics, and BioServe, the leading provider of clinically annotated tissue samples and provider of molecular marker research services, today announced that their technologies identified noncoding RNAs that were differentially expressed in healthy and diseased tissue. These micro ribonucleic acid (miRNA) sequences were either up or down-regulated between matched samples of RNA isolated from healthy colon and colorectal cancer tissues.  Data was presented in a poster at the annual meeting for the American Association for Cancer Research.

Invitrogen researchers used RNA samples from BioServe’s OncoRNA (http://www.bioserve.com/products/oncoRNA.cfm) product line, a series of RNAs isolated from fresh-frozen, fully annotated tumor and adjacent normal tissues, to probe the Ncode(TM) Human miRNA microarray V3.  Ncode(TM) Profiler software identified miRNAs that were either up- or down-regulated in tumor versus healthy tissue, and researchers used quantitative PCR to validate the findings.

“Using the high quality RNA samples from BioServe, we were able to identify novel microRNA sequences that could potentially be involved in the generation of new tumor tissues, particularly in colorectal cancer,” said Chris Adams, research and development leader of Epigenetics at Invitrogen.  “If more stringently validated, these disease-related microRNAs may eventually serve as targets for diagnostic or therapeutic development.”

MicroRNAs are short RNA sequences that do not code for specific proteins but are extremely important in the regulation of gene expression; they are implicated in several disease states including cancer and heart disease.  Among the activity of miRNAs is the triggering of messenger RNA (mRNA) degradation and the inhibition of protein translation – the process of assembling amino acids into proteins based on the instructions contained in mRNA sequences.  Invitrogen’s Ncode(TM) Human miRNA microarray V3 consists of miRNA content from multiple sources, including the Sanger 10.0 miRNA database and novel miRNAs unavailable in public databases, giving users access to strong content for identification and study of miRNAs.

“MicroRNA is making headlines in drug discovery for its ability to fine tune the activity of genes and its part in the formation of cancer,” said Kevin Krenitsky, chief executive officer, BioServe. “This makes it all the more critical that researchers can be certain they are working with stable, highly annotated samples collected under rigorous ethical and scientific protocols. We created OncoRNA to respond to this need, providing bench-ready RNA for tomorrow’s discoveries.”

About BioServe

BioServe is a leader in the processing, development, and validation of diagnostic tests for the practice of personalized, predictive and preventive medicine. Leading pharma, biotech and diagnostic firms collaborate with BioServe to identify and validate markers that cause disease while correlating clinical and molecular data to develop new diagnostic tests promoting wellness around the world. BioServe offers the Global Repository(R), a growing library of over 600,000 human DNA, tissue and serum samples linked to detailed clinical and demographic data from 140,000 consented and anonymized patients from four continents. Leveraging BioServe’s robust genomic analytical services, technology, Global Repository and CLIA-certified laboratory, collaborators gain a complete, highly efficient platform for processing diagnostic test results and identifying genomic markers for powerful new assays. BioServe has headquarters in Beltsville, MD and Hyderabad, India. For more information please visit www.bioserve.com or call 301-470-3362.

About Invitrogen

Invitrogen Corporation (NASDAQ:IVGN) provides products and services that support academic and government research institutions and pharmaceutical and biotech companies worldwide in their efforts to improve the human condition. The company provides essential life science technologies for disease research, drug discovery, and commercial bioproduction. Invitrogen’s own research and development efforts are focused on breakthrough innovation in all major areas of biological discovery including functional genomics, proteomics, stem cells, cell therapy and cell biology — placing Invitrogen’s products in nearly every major laboratory in the world. Founded in 1987, Invitrogen is headquartered in Carlsbad, California, and conducts business in more than 70 countries around the world. The company employs approximately 4,700 scientists and other professionals and had revenues of approximately $1.3 billion in 2007. For more information, visit www.invitrogen.com.

April 30, 2008

Validated biomarkers will drive personalized medicine

Filed under: Cancer Research, HIV Research, Press Releases — admin @ 7:12 pm

Biomarkers will be accepted as predicted tools, but their clinical usefulness needs to be understood
first, according to personalized medicine expert.

Coordinating personalized medicine on an international level, Dr Edward Abrahams, Executive
Director of the Personalized Medicine Coalition believes that biomarkers will eventually impact all
disease areas.

“When they were validated, and when it can be understood how clinically useful they are, biomarkers will be the easier method to understand the etiology of disease and human wellness,” commented Abrahams.

While the science of personalized medicine is fairly new, it is already being demonstrated in successful approaches to treating breast cancer and HIV. In cancer research in particular, industry is realising the potential of a separate diagnostic readout for every patient to allow for more targeted therapeutics. Abrahams sees biomarkers as “the scalpel that opens the patient,” but despite current success there are also serious issues for the uptake of personalized medicine, such as barriers to market.

The Personalized Medicine Coalition has been set-up to deal with such barriers in all levels of
research across the various industries involved. Evolving business models, demonstrating clinical
utility, and improving training at the bedside are just a few of the barriers that have affected “a clear regulatory pathway to co-develop personalized products,” commented Abrahams.

Despite warning of the serious issue of probability when using biomarkers as predictive tools, Abraham’s view of the future is bright: “I and many foresee a day when we’ll have predictive
biomarkers across all of healthcare.” With successful validation and clinical usefulness, advancing the use of biomarkers in industry will be a key stepping stone towards a personalized approach and the success of the healthcare system in the future.

Reducing healthcare costs will be a vital step to ensuring an effective system is in place for our aging populations; “personalized targeted therapies” may be one way to improve outcomes, with products tailored to each patient group. Highlighting this is one of the goals of the Personalized Medicine Coalition.

“Even if the individual products might cost more money, the system might save money by getting the approach right the first time.”

Hear more from Dr Edward Abrahams during his plenary lecture at the upcoming Informa Life
Sciences’ conference on ‘Advancing Biomarkers for Industry.’ Running alongside a Molecular
Diagnostics meeting, this takes place on 24-25 June 2008 in Brussels, Belgium. Find out more at
www.informa-ls.com/biomarkers

February 21, 2008

Norwich company joins cancer fight

Filed under: Europe, Research Projects, Cancer Research, Press Releases — Fred @ 2:03 pm

A new company based on the Norwich Research Park has joined the fight against MRSA and cancer.

Researchers at the John Innes Centre near Norwich have launched a new company, Inspiralis, based around their expertise in ‘DNA topoisomerases’.

These are a group of enzymes that help DNA molecules to unravel and wind up properly and not to become tangled during replication.

Inspiralis co-founder Nicolas Burton said: “DNA becomes tangled as a result of various cellular processes, such as replication, which ultimately stops these processes continuing. DNA topoisomerases untangle it. Without them, cells die.”

A number of powerful antibiotics and key anti-cancer drugs act by inhibiting topoisomerases.

In cancer, cells rapidly divide in an uncontrolled manner and topoisomerase inhibitors can block this uncontrolled division.

The search is now on for new ways of inhibiting topoisomerases.

Inspiralis makes a range of products targeted at the pharmaceutical industry to enable drug-discovery work in this area including topoisomerase enzymes themselves as well as associated products.

A new high-throughput test, developed recently in the laboratory of Prof Tony Maxwell of the John Innes Centre and co-founder of Inspiralis, will also provide a huge advance on the standard gel-based screening method for topoisomerase inhibitors.

Inspiralis will develop the technique further as well as offering screening services to companies.

“The test will potentially allow millions of compounds to be screened for activity rather than just hundreds,” said Dr Burton.

The technology can now be accessed as a service or as a kit helping pharmaceutical companies and academics to screen for new and better cancer drugs and antibiotics.

“Topoisomerase inhibitors are key targets for new drug development”, said Alison Howells, a co-founder of Inspiralis.

“We can test potential new drugs against topoisomerases as well as help discover new inhibitors as a first step to developing brand new drugs.”

Inspiralis is based at the Norwich Bio-Incubator at JIC and was founded with backing from the Iceni fund, a private investor, and the John Innes Centre.

The high-throughput test is patented by JIC’s and BBSRC’s technology transfer company, Plant Biosciences, and non-exclusive licenses have already been granted to pharmaceutical companies to utilise the equipment.

February 13, 2008

DNA with a twist: New company to search for cancer drugs and antibiotics

Filed under: Europe, Cancer Research, Press Releases, DNA Reasearch — Fred @ 2:12 pm

A new company has joined the fight against MRSA and cancer. Researchers at the John Innes Centre (Norwich) have launched a new company, Inspiralis Ltd, based around their expertise in DNA topoisomerases – a group of enzymes that help DNA molecules to unravel and wind up properly and not to become tangled during replication.

“DNA becomes tangled as a result of various cellular processes, such as replication, which ultimately stops these processes continuing. DNA topoisomerases untangle it. Without them cells die”, says Inspiralis co-founder Dr Nicolas Burton.

Topoisomerases are already targets for several drugs, including anti-tumour drugs and antibiotics, such as ciprofloxacin – the anti-anthrax drug. The search is now on for new ways of inhibiting them. Inspiralis Ltd make a range of products targeted to the pharmaceutical industry to enable drug-discovery work in this area including topoisomerase enzymes themselves as well as associated products.

A new high-throughput assay, developed recently in the laboratory of Prof. Tony Maxwell of the John Innes Centre (and co-founder of Inspiralis), will also provide a huge advance on the standard gel-based screening method for topoisomerase inhibitors. Inspiralis Ltd will develop the technique further as well as offering screening services to companies. “The assay will potentially allow millions of compounds to be screened for activity rather than just hundreds”, says Dr Burton.

The technology can now be accessed as a service or as a kit helping pharmaceutical companies and academics to screen for new and better cancer drugs and antibiotics.

Some powerful antibiotics and key anti-cancer drugs act by inhibiting topoisomerases. In cancer, cells rapidly divide in an uncontrolled manner and topoisomerase inhibitors can block this uncontrolled cell division.

“Topoisomerase inhibitors are key targets for new drug development”, says Mrs Alison Howells (co-founder). “We can test potential new drugs against topoisomerases as well as help discover new inhibitors as a first step to developing brand new drugs”.

Inspiralis is based at the Norwich Bio-Incubator at JIC and was founded with backing from the ICENI fund, a private investor and the John Innes Centre.

The high-throughput assay is patented by JIC’s and BBSRC’s technology transfer company, Plant Biosciences Ltd, and non-exclusive licenses have already been granted to pharmaceutical companies.

January 3, 2008

New drug target leaves lung cancer cells alone, lonely and dying

It seems even tumour cells can get lonely; scientists have discovered that by cutting off a key gene, lung cancer tumour cells are left ‘homeless’ and they can’t survive on their own.
The gene in question is called 14-3-3zeta and it can now be considered a potential target for selective anticancer drugs, according to Professor Haian Fu at the Emory University School of Medicine. These latest research results were published in the 24 December edition of the Proceedings of the National Academy of Sciences (PNAS).

Lung cancer kills more Americans annually than any other type of cancer, according to the National Cancer Institute. Yet treatment options are very limited.

“The recent trend towards targeted therapies requires us to understand the altered signalling pathways in the cell that allow cancer to develop,” said Prof. Fu.

“If you think about genes that are deregulated in cancer as drivers or passengers, we want to find the drivers and then, aim for these drivers during drug discovery.”

Prof. Fu and his collaborator, Dr Fadlo Khuri, deputy director of clinical and translational research at Emory Winship Cancer Institute, chose to focus on the gene 14-3-3zeta because it is activated in many lung tumours. In addition, recent research elsewhere shows that lung cancer patients are less likely to survive if the gene is on overdrive in their tumours, Dr. Fu explained.

There are seven 14-3-3 genes, each designated with a Greek letter. Their protein products act as adaptors that can clamp onto other proteins, depending on whether the target protein has been phosphorylated or not. One of the pathways 14-3-3 helps control is epidermal growth factor receptor (EGFR) signalling, which drives the growth of lung cancer.

The team of scientists, including lead author Dr Zenggang Li, used RNA interference (RNAi) to selectively silence the 14-3-3zeta gene. They found that when 14-3-3zeta is turned off, lung cancer cells become less able to form new tumour colonies in a laboratory test.

One of the most important properties of cancer cells is their ability to grow and survive without touching other cells or the polymers that connect them. The researchers found that if they turned 14-3-3zeta off, the tumour cells once again become vulnerable to anoikis (Greek for homelessness), a form of cell death that occurs when cells that are accustomed to growing in layers find themselves alone.

“You can see how control of anoikis means 14-3-3zeta could play a critical role in cancer invasion and metastasis,” Dr. Fu says. “The mechanistic question we still haven’t answered is: what makes zeta unique so that it can’t be replaced by the others.”

Further experiments also showed that 14-3-3zeta regulates the Bcl2 protein family, which is a popular target for cancer drug developers thanks to its role in cell death. If 14-3-3zeta is absent, it upsets the balance within the Bcl2 family.

The finding has implications beyond lung cancer, in that 14-3-3zeta is also activated in other forms of cancer such as breast and oral, he notes.

“Targeting this critical molecule could lead to meaningful therapeutic progress,” said Dr Khuri.

Dr Fu and his co-workers are using a robot-driven screening programme at the Emory Chemical Biology Discovery Center to sort through thousands of chemicals that may disrupt its interactions specifically. They hope to identify these compounds rapidly and move them from bench into clinic testing to benefit patients.

December 19, 2007

Michael J. Fox Foundation Awards $4.4 Million for Development of New Class of Parkinson’s Therapy

NEW YORK, Dec. 18 /PRNewswire-USNewswire/ — The Michael J. Fox Foundation has awarded $4.4 million to jump-start the development of a new class of symptomatic Parkinson’s disease drugs targeting glutamate receptor mGluR4. The funding was awarded to a multidisciplinary team of researchers led by Jeffrey Conn, PhD, of Vanderbilt University under the Foundation’s LEAPS (Linked Efforts to Accelerate Parkinson’s Solutions) 2007 initiative.

The LEAPS 2007 program was funded with a lead gift from the Edmond J. Safra Philanthropic Foundation. The Edmond J. Safra Philanthropic Foundation has been one of the most steadfast supporters of The Michael J. Fox Foundation since its inception.

“Dopamine replacement therapies have long been considered the ‘gold standard’ of Parkinson’s treatment. But they lose efficacy over time, alleviate only some of PD’s symptoms, and cause side effects that can be as debilitating as the disease itself,” said Katie Hood, CEO of MJFF. “Patients don’t think this status quo is good enough, and neither does our Foundation. Dr. Conn and colleagues are aiming to bring about a 180-degree turn in PD treatment by developing an entirely new class of drugs that would bypass the dopamine system altogether.”

The death of dopamine neurons is a hallmark of PD pathology, and Parkinson’s scientists traditionally have focused their efforts on modulating aspects of the dopamine system. But recent insights into the physiology of the basal ganglia (a brain region affected in Parkinson’s disease) have shed light on the potential for treatments that could alleviate PD symptoms by “resetting” brain circuits. The glutamate system in particular has shown promise as a target for such treatments.

Glutamate, like dopamine, is a neurotransmitter — a signaling molecule that plays a role in transporting brain messages and controlling body functions. In previous work, Dr. Conn showed in an animal model that increasing activity of a specific glutamate receptor, mGluR4, may alleviate symptoms of Parkinson’s. In further work supported by MJFF’s Target Validation initiative, his team identified molecules that increase mGluR4 activity. The researchers will now use a combination of medicinal chemistry, molecular biology, and animal studies to engineer these molecules into a compound that can be clinically tested for use as a drug that could provide sustained symptomatic relief.

LEAPS are multi-year, multi-million, multi-disciplinary projects that bring together “all-star” teams of researchers to address questions with significant practical impact on the treatment of Parkinson’s disease. Continued funding is dependent on completion of predetermined milestones at specific stages.

In addition to coordinating principal investigator Dr. Conn, who is professor of pharmacology and director of the Vanderbilt Program in Drug Discovery, this LEAPS team includes:

C. David Weaver, PhD, Research Associate Professor of Pharmacology; Director, Vanderbilt Institute of Chemical Biology High-throughput Screening Facility; Director, New Leads Discovery, Vanderbilt Program in Drug Discovery — Dr. Weaver will oversee the high-throughput screening to identify initially promising lead compounds.

Colleen Niswender, PhD, Research Assistant Professor, Department of Pharmacology; Head, Molecular Pharmacology Team, Vanderbilt Program in Drug Discovery — Once lead compounds have been identified through high-throughput screening, Dr. Niswender will be responsible for screening them in cell-based assays to determine which hold the most promise to move on to testing in animal models.

Carrie K. Jones, PhD, Research Associate Professor, Department of Pharmacology; Head, In Vivo and Behavioral Pharmacology Group, Vanderbilt Program in Drug Discovery — Dr. Jones will spearhead the screening of lead compounds in rodent behavior models of Parkinson’s disease.

Yoland Smith, PhD, Professor, Department of Neurology, Yerkes National Primate Research Center, Emory University — Dr. Smith, an expert in the neurophysiology of primate models of Parkinson’s, will oversee the testing of the most promising lead compounds in the final preclinical phase of the project.

Craig W. Lindsley, PhD, Associate Professor of Pharmacology and Chemistry; Director of Medicinal Chemistry, Vanderbilt Program in Drug Discovery; Director, Vanderbilt University MLSCN (Molecular Libraries Screening Center Network) Chemistry Center and Vanderbilt Institute of Chemical Biology Synthesis Core — Dr. Lindsey, a medicinal chemist, will hold ultimate responsibility for optimizing engineering of the compound that will be tested in the clinic.

December 1, 2007

Profiling of Tumor Tissue Slices is Awarded Prize

Novel drug screening tool based on the Bionas® 2500 analyzing system wins silver medal in European business plan contest

Rostock, Germany, November 26, 2007 / b3c newswire / - Bionas GmbH, a specialist for in vitro profiling the metabolic activity of cells, announced that Prof. Pedro Mestres of the Saarland University (Homburg/Saar, Germany) has been awarded the second prize in the business plan contest 1,2,3 GO for a novel drug sensitivity screening tool based on the Bionas technology.

Tumors react in different ways against anti-cancer drugs. It is therefore important to determine tumor drug sensitivity in order to establish a tumor and patient-specific therapy in the clinic.

Prof. Mestres, who plans to found a company for drug screening services in early 2008, has developed a tissue slicing technology producing microtumors that retain near-original tissue structure and cell activity. These microtumors are then analyzed with the Bionas® 2500 analyzing system for their metabolic activity upon drug treatment.

With the Bionas 2500 instrument we can analyze the metabolic pattern of the tissue slices in a highly precise way, “says Prof. Pedro Mestres. “This enables us to profile tissue specimens from tumor patients for optimal drug responsiveness”.

The Bionas® 2500 analyzing system gives a complete overview of the physiological state of cells and tissues by analyzing metabolic and morphological parameters over a long period.

About Bionas www.bionas.de
Bionas GmbH, located in Rostock, Germany, specializes in analyzing systems and services for in vitro profiling the metabolic activity of cells to understand cellular function. Bionas® 2500 analyzing system measures extracellular acidification, oxygen consumption and cell adhesion label-free and noninvasively. It can be applied to various cell types including primary cells and tissues. The readout is performed continuously and can be monitored online. Main applications include drug profiling, lead optimization, pharmacokinetics, early toxicology programs, ADME/Tox, chemosensitivity testing, toxicological testing of chemical substances (REACH) and cell culture monitoring and optimization.

October 22, 2007

Gossypol Biological Properties

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

October 18, 2007

Strategic Diagnostics Launches Initial Oncology-Targeted Antibody Reagent Catalog

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.

August 13, 2007

BioServe and Phenomenome Discoveries Develop Novel Diagnostic Test for Colorectal Cancer

Filed under: Collaborations, Cancer Research, Press Releases — Fred @ 1:08 pm

Laurel, MD and Saskatoon, SK, Canada, August 6, 2007 – BioServe and Phenomenome Discoveries Inc. (“PDI”) today announced that they have developed a novel serum-based diagnostic test for the identification of colorectal cancer (CRC), and pre-cancerous states conducive to the development of CRC. Colorectal cancer comprises a tenth of the global cancer burden, and is the third most common malignancy in the world. According to the National Cancer Institute, in the United States during 2007 there were an estimated 153,760 new cases of colorectal cancer and 52,180 deaths from the disease.

The new colorectal cancer diagnostic test is currently available in Canada and Japan. Both companies anticipate that the test will be available for distribution in the United States in Q4 2007. The test is also currently available for use by researchers worldwide as a fee-for-service research tool that allows research-use-only applications. Further plans for broad commercialization to physicians and patients are underway.

In developing the test, BioServe identified a large number of patient tissue and serum samples from its Global Repository® exhibiting CRC across a spectrum of stages, as well as matched healthy controls. Using PDI’s patented non-targeted metabolomics platform, PDI discovered that a series of novel metabolites were significantly decreased in serum samples collected from colorectal cancer patients compared to controls. From these results, PDI developed a two minute high-throughput screening method capable of simultaneously measuring a key subset of these molecules. BioServe provided a second independent population of 189 CRC samples and 287 controls, and the rapid test was found to be 78% sensitive and 90% specific in this validation sample set.

The test has now been validated in four independent studies, across which the sensitivity of detection for colorectal cancer positive cases averaged 75%, and the specificity averaged 90%. Trials are planned for late 2007 in Canada and Japan, in which healthcare authorities will evaluate the test’s utility as part of a broad-based population screening regimen.

“Early detection is the single most important factor in improving patient survival. The availability of a simple, serum-based, pre-colonoscopy screening test for CRC will have a positive impact on the low compliance rate of colonoscopy as a screening tool and enable healthcare providers to make more efficient use of the colonoscopy in the management of CRC,” said John Hyshka, Chief Operating Officer of PDI. “BioServe’s clinical colorectal cancer data and control samples from its vast Global Repository of over 600,000 human DNA, tissue and serum samples were critical to accelerating our research in colon cancer and developing this breakthrough diagnostic test. Based on our success in CRC, we have expanded our collaboration with BioServe to identify serum biomarkers for other forms of cancer as well as multiple sclerosis.”

“The development of this new and novel diagnostic test for colorectal cancer showcases how BioServe successfully collaborates with partners to gain insights to disease at the deep molecular level to advance the science of personalized and predictive medicine,” said Kevin Krenitsky, Chief Executive Officer, BioServe. “PDI is at the forefront of molecular biomarker research and discovery, and we look forward to the discovery of similar biomarkers in other diseases as a result of our expanded collaboration with PDI and to the development of more ‘wellness’ enhancing diagnostics.”


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