Bio Screening Industry News

Rockville, MD, April 23, 2008: Seegene today announced that its Seeplex(R) multi-pathogen tests are now optimized for Lab 901’s ScreenTape(R)  and Caliper LifeSciences’ LC90(R)  automated detection systems. Compatibility with these two leading detection systems opens the way for Seeplex tests to be used throughout a wide spectrum of labs, from small to mid-sized labs to large commercial reference labs.

Seeplex tests are based on a breakthrough multiplexing PCR technology capable of detecting multiple pathogens in a single tube. Seeplex-based tests deliver maximum specificity, reproducibility and sensitivity and can be applied to a broad range of molecular diagnostics, including human, animal, plant and microorganism. Currently, Seegene’s Seeplex multi-pathogen detection tests offer labs worldwide simple, cost-effective and comprehensive screening for STDs, respiratory viruses, human papillomaviruses, sepsis and pneumonia.

“Our broad portfolio of multi-pathogen detection tests being optimized for ScreenTape and the Caliper LC90 systems will make it easier for clinical and research labs of all sizes to take advantage of our technology,” said Dr. Jong-Yoon Chun, Founder and Chief Executive Officer, Seegene. “Both the Lab901 and Caliper LifeSciences systems represent the cutting edge of automated detection. Working in combination with these leading systems provides a powerful high-throughput method for analyzing test results.”

The ScreenTape system is the first fully automated, walk-away solution for gel electrophoresis. ScreenTape will automate the simultaneous analysis of eight or sixteen Seeplex PCR samples. Processing speed for 8 samples is completed within 10 minutes;  16 samples within 15 minutes. ScreenTape displays results using easy to interpret color codes. The ScreenTape system comprises the TapeStation (that carries out liquid handling, electrophoresis and imaging), ScreenTape (a consumable that contains the pre-cast, pre-packaged gel and running buffer) and bespoke software. With no gel or buffer preparation and no system priming, even untrained operators can rapidly generate accurate and reproducible test data.

The LabChip 90 System performs fast, automated, 1-D electrophoretic separations of protein, DNA, and RNA samples directly from a 96 or 384 well plate. The LC90 can load and read 96 Seeplex samples within 45 minutes or 384 Seeplex samples in 4 hours in easy-to-interpret reports.

Seegene is currently working to optimize Seeplex tests for other automated capillary electrophoresis systems. Seeplex’s compatibility with a wide range of automated detection systems will provide end-users with the flexibility to use the platform best suited for their purposes.

About Seeplex(R) System: Frontier of Multi-pathogen Detection

Seeplex(R) is a breakthrough multiplexing PCR technology that enables a new standard in simultaneous multi-pathogen detection. Seeplex works in combination with automatic detection systems such as Capillary Electrophoresis and delivers a benchmark in testing accuracy, efficiency and cost-effectiveness.

About Seegene

Seegene, Inc. is pioneering the field of multi-pathogen testing. Seegene applies its novel and proprietary Seeplex system utilizing “DPO (Dual Priming Oligo)” and “ACP (Annealing Control Primer)” to create multi-pathogen tests delivering maximum specificity, reproducibility and sensitivity. With over 260 citations and several patents and patents pending, Seegene has been offering advanced molecular diagnostics services to over 1,000 major global institutes in more than 25 countries. Seegene is actively working with both the scientific and OEM business community. Seegene’s mission is to integrate Seeplex with disease diagnostics to provide a new guideline for effectively treating patients. Seegene was founded in 2000 and is based in Rockville, MD and Seoul, Korea. For more information please visit www.seegene.com.

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.

New line of DNA and serum samples for Type II diabetes, hypertension and hyperlipidemia provide researchers access to clinically defined controls to validate biomedical research results

Beltsville, MD, December 4, 2007 – BioServe today introduced ControlMATCH, a new line of fully annotated control DNA and serum samples designed to help biomedical researchers efficiently validate new biomarkers and early stage clinical trial drug candidates. Leveraging BioServe’s Global Repository of 600,000 human biological samples, ControlMATCH allows researchers to select and match control samples to the specific needs of their own DNA and/or serum-based studies.

ControlMATCH DNA and serum controls will initially cover type II diabetes, hypertension and hyperlipidemia, and extend to other disease states in early 2008.

ControlMATCH normal samples for type II diabetes, hypertension and hyperlipidemia are annotated with body mass index (BMI), confirmed normal blood glucose levels, confirmed normal blood pressure and cholesterol levels, and a family history of health status and ethnicity determined by data collected on three generations. ControlMATCH therefore permits researchers to identify one-to-one matched controls for extended criteria such as age, gender, ethnicity, BMI, diet and a host of lifestyle factors. Furthermore, ControlMATCH includes clinically confirmed negative results enabling researchers to further confirm that their markers are valued against the correct set of controls.

Xin Li Wang, a professor and director in the cardiothoracic research laboratory in the division of cardiothoracic surgery of the Michael E. DeBakey Department of Surgery at Baylor College of Medicine, commented, “We are engaged in landmark cardiothoracic studies that we hope will reveal the DNA aberrations in a few target genes responsible for thoracic aortic disease. Like any large epidemiological study, time is money and generating valid results as quickly as possible is a prerequisite for success.”

“The faster a study is able to generate validated results, the higher the probability of achieving longer term program milestones. By providing us with ready made DNA samples stratified by age, ethnicity and smoking status, BioServe’s ControlMATCH has proven to be an indispensable tool in accelerating our research,” he added.

“ControlMATCH was developed to be a powerful validation tool for epidemiologists and researchers investigating a variety of major diseases,” said Kevin Krenitsky, Chief Executive Officer, BioServe.  “DNA and serum control sets linked to extensive clinical, demographic and lifestyle data will enable researchers to both rapidly validate which markers are valuable and worth pursuing, and generally contribute to the genetic understanding of debilitating disease.”

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®, 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.

(Amherst, NH) - The success of recombinant protein drugs such as Enbrel, Remicade, and Herceptin in treating refractory conditions is fueling the search for protein and peptide-based therapeutic agents in oncology, inflammation and a host of other disease classes. Led by the proliferation of antibody-based drug candidates, biological drugs as a class continue to outpace all other NCEs in development pipelines and clinical trials. This shift away from small molecule drugs is creating opportunities for drug developers, device designers, packagers and - ultimately - pharmaceutical marketers.

Because biological drugs most often target chronic conditions, dosing strategies and treatment protocols must be developed for long-term use, often for self-administration by patients who may have limitations directly related to their condition. The powerful physiological effects of antibodies, hormones and other biological drugs also increase the need for safety and compliance.

Compliance with drug therapy and disease management protocols has been and is a primary concern within the healthcare and pharmaceutical industries. Efforts to enhance compliance are having a non-negligible effect on drug formulations and delivery decisions, and can be a significant factor in the prescribing decisions of most physicians. Compliance concerns have driven and continue to drive investment in new drug delivery technologies.

As patients live longer and are diagnosed with chronic and often debilitating ailments, the result will be a dramatic increase in self-administration of drug therapies in non-traditional settings for a number of conditions. This trend is creating an increased interest in routes of administration that are patient-friendly and cost-effective. Pharma company decision makers have come to the realization that new drug product success no longer only depends on the medication itself but also on achieving a patient-friendly form of application.

New injectable delivery device designs currently being developed will create new opportunities for alternative injection methods. Reusable injectors designed to accept prefilled syringes or drug cartridges will improve ease-of-use and increase alternative device share of the growing self-injection market. Partnerships between device suppliers and pharmaceutical companies will foster market acceptance of new injection devices for a host of new therapies such as therapeutic vaccines, DNA-based drugs, and protein-derived biologics.

These findings are contained in a comprehensive report, Injectable Drug Delivery: Evolving Markets, Emerging Opportunities. More information is available at www.greystoneassociates.org .

About Greystone
Greystone Associates is a medical and healthcare technology consulting firm providing services in strategic planning, venture development, product commercialization, and technology and market assessment.

BioServe’s fully annotated clinical samples across many diseases to be tagged with ancestry information using DNAPrint’s genetic ancestry tests

BELTSVILLE, MD., Oct. 9, 2007 – BioServe today announced the formation of strategic alliance with DNAPrint® Genomics, Inc. (OTCBB: DNAG) to provide biomedical researchers with clinical DNA samples that for the first time will include genetic ancestry data for each sample. With the added dimension of ancestry information to clinical samples, medical researchers will be able to determine whether certain biological markers are artifacts of genetic ancestry or are true markers for a disease or drug response in a disease. To create the genetic ancestry data, DNAPrint® Genomics will analyze and categorize BioServe’s Global Repository® of nearly 600,000 human biological samples using its ANCESTRYbyDNA(TM) validated genetic ancestry test.

“Our relationship with BioServe is highly synergistic. Both companies believe that any epidemiological program will be more productive with access to high quality validated clinical samples that have been effectively categorized across a validated genetic ancestry platform,” said Richard Gabriel, CEO and President of DNAPrint® Genomics. “By removing the question of ancestry from a clinical sample researchers can more readily evaluate which medicines will produce side effects within certain ethnic groups, and which medicines will work for the widest spectrum of a population.”

“Through this partnership with DNAPrint Genomics we can provide the medical research community with the best defined clinical sample set in the world,” said Dr. Kevin Krenitsky, CEO of BioServe. “Additionally, we are able to uniquely support the application of our samples with services that include sample extraction and preparation, genotyping, and gene expression. Now that we are able to add the genetic ancestry component to our samples, a new layer of sample data quality and analysis can be provided that was not previously available to researchers.”

Both companies are also capable of providing genotyping services, and between the two companies the following platforms are available: Beckman Ultra High Throughput SNP Platform, Illumina SNP Golden Gate, and Sequenom iPLEX. In addition, several gene RNA expression analysis platforms are available including Differential Expression Pattern Display Technology which has an RNA expression sensitivity 10 to 100 times greater than either of Affymetrix or Illumina gene expression profile technologies.

DNAPrint™ Genomics, Inc.

DNAPrint™ Genomics, Inc. (www.dnaprint.com) is a developer of genomics-based products and services in two primary markets: biomedical and forensics. DNAPrint Pharmaceuticals, Inc., a wholly owned subsidiary, develops diagnostic tests and theranostic products (drug/test combinations) using the Company’s proprietary ancestry-informed genetic marker studies combined with proprietary computational modeling technology. Computational Biology and Pharmacogenomics services are also offered externally to biopharmaceutical companies. The Company’s first theranostic product is PT-401, a “Super EPO” (erythropoietin) dimer protein drug for treatment of anemia in renal dialysis patients (with end stage renal disease). Preclinical and clinical development of all the Company’s drug candidates will benefit from simulated pre-trials to design actual trials better and are targeted to patients with genetic profiles indicating their propensity to have the best clinical responses. DNAPrint is proud of its continued dedication to developing and supplying new technological advances in law enforcement and consumer ancestry heritage interests. Please refer to www.dnaprint.com for information on law enforcement and consumer applications which include DNAWITNESS(TM), RETINOME(TM), ANCESTRYbyDNA(TM) and EURO-DNA(TM). DNAWitness-Y and DNAWitness-Mito are two tests offered by the Company. The results from these tests may be used as identification tools when a DNA sample is deteriorated or compromised or other DNA testing fails to yield acceptable results.

About BioServe

BioServe (www.bioserve.com) 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®, 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, e-mail info@bioserve.com or call 301-470-3362.

Forward-Looking Statements

All statements in this press release that are not historical are forward-looking statements. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected, including, but not limited to, uncertainties relating to technologies, product development, manufacturing, market acceptance, cost and pricing of DNAPrint’s products, dependence on collaborations and partners, regulatory approvals, competition, intellectual property of others, and patent protection and litigation. DNAPrint Genomics, Inc. expressly disclaims any obligation or undertaking, except as may be required by applicable law or regulation to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in DNAPrint’s expectations with regard thereto or any change in events, conditions, or circumstances on which any such statements are based.