NC-based pharmacogenomics company has achieved its first FDA product clearance just two years after launching diagnostics division

Research Triangle Park, NC -- (ReleaseWire) -- 02/06/2007 -- Gentris Corporation (Gentris) today announced FDA clearance for GentriSure™, its first product line and the first FDA-cleared product for this specialty pharmacogenomics company. These six Human Genomic Reference Controls, the first products of their kind approved by a federal agency, are used to perform diagnostic testing for the Cytochrome P450 2D6 gene (CYP2D6). Gentris, a leading global provider of applied clinical pharmacogenomic services and diagnostic product solutions, can now add FDA approval and a GMP-compliant device manufacturer to its long list of accomplishments.

"The FDA's approval of our GentriSure product line is an extremely important achievement for Gentris," said Michael Murphy, the company's President and CEO. "It demonstrates our ability to implement a GMP-compliant facility, as well as to navigate the regulatory process. This latest development also proves our capability to expediently manage the complexities of conducting clinical trials with our products." he added. "We are already applying the same model to other products in our pipeline."

FDA approval reflects the growing demand for consistent, reliable genomic material obtained from properly consented patients. Previously, the only other sources of available reference materials for CYP2D6 diagnostic testing were surplus human specimens and synthetics. All of these materials are generally less desirable due to consistency, ethical and representative issues.

"Gentris' FDA-cleared human genomic reference controls for CYP2D6 set an important precedent in the pharmacogenomics arena," commented William Evans, Pharm.D., Director and CEO, St. Jude Children's Research Hospital in Memphis, Tennessee. "Controls are as important as tests in ensuring accurate and safe clinical testing. As one of the few FDA cleared pharmacogenomic-related diagnostics, each new Gentris product is a step closer to personalized drug treatment," said Dr. Evans.

In compliance with strict FDA submission requirements, Gentris conducted user trials at three outside, independent sites to validate the efficacy and quality of these products. The sites included one of the world's largest clinical reference laboratories, a world-renowned reference laboratory for national and international clinics and hospitals, and an independent laboratory spun out of a university that specializes in clinical pharmacogenetic testing. GentriSure controls were tested on several CYP2D6 test platforms including laboratory developed assays. Notably, GentriSure Human Genomic Reference Controls were tested on the Roche AmpliChip®, CYP450 Test, the only FDA cleared device for CYP2D6 testing on the market.

About Gentris Corporation
Gentris Corporation is a leading global provider of applied clinical pharmacogenomic services and diagnostic product solutions. As pioneers in the field of pharmacogenomics, Gentris helps pharmaceutical companies and clinical research organizations effectively integrate pharmacogenomics into their drug development programs to deliver safer, more effective compounds to the market sooner. Gentris is developing validated reference controls and diagnostic test kits that will bring the promise of personalized medicine to physicians and patients, which will enhance patient management, improve patients' response to therapy and revolutionize medicine through pharmacogenomics. For additional information, please visit http://www.gentris.com

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LGC Promochem to market and distribute GentriSure™ product range in Europe and India

Teddington, London, UK -- (ReleaseWire) -- 01/10/2007 -- LGC Promochem, Europe's leading supplier of reference standards, will bring to Europe a new milestone in DNA standards for use in drug-response genotyping assays. LGC has agreed terms with Gentris Corporation for the marketing and distribution of their pioneering GentriSure range of Human Genomic Reference Controls (HGRC).

The GentriSure products, developed at the Gentris facility in Morrisville, North Carolina, offer the first of an ever-expanding menu of highly characterised controls for a variety of key genetic polymorphisms which directly impact drug response. Currently available controls contain polymorphisms for CYP2D6, CYP2C19, CYP2C9 and VKORC1 genes. Until now, finding a consistent, reliable and commercial source of reference controls for genotyping laboratories to use in their quality assurance and proficiency testing programmes has been a challenge. The GentriSure products offer a highly characterised source of human genomic DNA and the agreement with LGC Promochem will facilitate easier access to the controls for laboratories across Europe and in India.

The controls are isolated from B-lymphoblastoids derived from fully consented, individual donors. DNA sequences are verified using bi-directional sequencing. Importantly, there are no artificial DNA sequences introduced to the cell lines so the controls are virtually identical to genomic DNA isolated from typical patient samples. Clearance for some of the products is expected from the United States Food and Drug Administration (FDA) early next year.

Commenting on the new partnership, Dr Matthias Brommer, Director, Laboratory Quality Products and Services at LGC, indicated the potential the new agreement with Gentris brings to the market: "We are excited by the synergy that this collaboration will create. The analysis of polymorphisms affecting drug metabolism, as with many other areas of genetic analysis, will play an increasingly important role in drug development and delivery. LGC Promochem is ideally positioned to create a centre through which standards to support genetic analysis can be distributed to laboratories both in Europe and across the world. The GentriSure products offer the most highly characterised DNA controls of their type and are a welcome addition to the LGC Promochem portfolio."

This will be the second time in the past 12 months that the two leading companies have announced partnership agreements. In August this year, LGC and Gentris Corporation announced a licensing agreement that gives Gentris the right to make, use and sell diagnostic products and services which include testing for the CYP2D6*4 polymorphism in the US.

"We are building on the success of our earlier partnership with LGC to deliver clinical pharmacogenomic products to key markets throughout the world. This is a confirmation of our commitment to building the industry's most robust and relevant portfolio of genetic testing reference controls and diagnostic kits," commented Gentris CEO Michael Murphy.

About LGC Promochem's reference materials business
The reference materials business at LGC Promochem is a Europe-wide distribution business focused on a number of key market sectors including pharmaceutical testing, food analysis, environmental analysis, forensic science, clinical science and general analyte determination. Reference materials assist analysts dealing with a broad range of analyses to improve the accuracy, traceability and repeatability of a diverse range of chemical measurements. LGC Promochem's head office is located at LGC's Teddington laboratory in the UK with the network of European distribution offices including UK, Spain, Sweden, Italy, Germany, Poland, France and India. LGC Promochem has distribution partnerships with many of the world's leading reference materials producers, including ATCC, ULTRA Scientific, Cambridge Isotope Laboratories, NMIA, Cerilliant and the Institute for Reference Materials and Measurements.

About Gentris Corporation
Gentris Corporation (www.gentris.com) is a leading global provider of clinical pharmacogenomic diagnostic solutions. As pioneers in the field of pharmacogenomics, Gentris is setting the standard for genetic testing controls with its GentriSure™ line of human genomic reference controls. Gentris is also developing diagnostic test kits that will deliver rapid results for direct patient testing. By providing access to these innovative personalised medicine solutions, Gentris is contributing to enhance patient management, improve patients' response to therapy and, ultimately, revolutionising medicine through pharmacogenomics.

About LGC
LGC, an international science service company, is a leading independent provider of analytical and diagnostic services and reference standards. LGC's operations comprise: LGC Forensics, Life and Food Sciences, Pharmaceutical and Chemical Services and, for products and services for laboratory quality, a single division embracing LGC Promochem, LGC's proficiency testing offering (based in Bury, UK) and our pharmaceutical impurity reference standards business. LGC's research-led Analytical Technology and Government Chemist division houses specialist laboratories for the delivery of contracts under the DTI's Office of Science and Innovation and to serve its designated role as the UK's National Measurement Institute for chemical and biochemical analysis. LGC is headquartered in Teddington, Middlesex, UK. LGC has laboratories located in Teddington, Runcorn (Cheshire), Culham (Oxfordshire), Risley (Cheshire), Tamworth (Staffordshire), Edinburgh (Scotland), Luckenwalde (Germany) and Bangalore (India). LGC also has offices in France, Germany, Italy, Poland, Spain, Sweden and India. In 2006, AGOWA, a specialist genomics company based in Berlin, and the Institut fuer Blutgruppenforschung, a provider of DNA services in paternity testing and forensic genetics based in Cologne, joined the Group.

For further information, please contact:

Imelda Topping
Group Communications Manager
LGC
Queens Road, Teddington
Middlesex, TW11 0LY
Tel: +44 (0) 20 8943 7563
Fax: +44 (0) 20 8943 2767
Web: www.lgc.co.uk

Mariana McCulley
919 Marketing
USA
Tel: 919.557.7890
Email: press@gentris.com

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Dr. Andrea Gaedigk of Children’s Mercy Hospital & Clinics joins advisory board of leading scientists

Research Triangle Park, NC -- (ReleaseWire) -- 11/10/2006 -- Gentris Corporation (Gentris), a leading global provider of applied clinical pharmacogenomic services and diagnostic product solutions, today announced the appointment of Andrea Gaedigk, M.S., Ph.D. to the company's Scientific Advisory Board.

Dr. Gaedigk's work encompasses basic and translational research at Children's Mercy Hospital & Clinics, where she directs the Pharmacogenetics Core Laboratory within the Division of Pediatric Clinical Pharmacology and Medical Toxicology. Dr. Gaedigk is considered a leading specialist on the pharmacogenetics of drug metabolizing enzymes, in particular, the cytochrome P450s. She has published over 60 peer-reviewed papers and presented her work in over 100 abstracts at national and international scientific conferences. She serves as a co-investigator on numerous NIH-funded projects.

"Every member of this world-class Scientific Advisory Board provides specific expertise and knowledge of a discipline that is critical to rapid development, regulatory approval and commercialization of Gentris products or services," said Gentris CEO, Michael P. Murphy. "The members of our Scientific Advisory Board also share our vision of a future where drug delivery is safer and more personalized for each patient."

Welcoming Dr. Gaedigk are fellow Gentris Scientific Advisory Board members: William E. Evans, Pharm.D., Director, St. Jude's Children's Hospital; Janice Kurth, M.D., Ph.D., Vice President of Life Sciences, Visualize Inc.; and Paul A. Andrews, Ph.D., R.A.C., Head of Toxicology Department, ImClone.

About Gentris Corporation
Gentris Corporation is a leading global provider of applied clinical pharmacogenomic services and diagnostic product solutions. As pioneers in the field of pharmacogenomics, Gentris helps pharmaceutical companies and clinical research organizations effectively integrate pharmacogenomics into their drug development programs to deliver safer, more effective compounds to the market sooner. Gentris is developing validated reference controls and diagnostic test kits that will bring the promise of personalized medicine to physicians and patients, which will enhance patient management, improve patients' response to therapy and revolutionize medicine through pharmacogenomics. For additional information, please visit http://www.gentris.com.

For more information on this press release visit: http://www.releasewire.com/press-releases/release-3.htm

NC Technology Association and TotalCare IT Solutions team up to conduct “IT Landscape & Challenges” Survey

Raleigh, NC -- (ReleaseWire) -- 10/31/2006 -- The North Carolina Technology Association (NCTA) and TotalCare IT Solutions by Alphanumeric are joining forces to conduct a survey of NC-based organizations, in an effort to better understand what IT choices area companies are making to accomplish strategic business goals.

Beginning this week, NCTA members and other North Carolina-based businesses will be invited to respond to an online questionnaire asking them to reflect on the biggest IT concerns for their organization, decisions on outsourcing IT elements and projected spending levels on IT in 2007.

"There is a great deal of national data accumulated by major research organizations and analysts, but until now there has never been an attempt to collect data on IT issues and outsourcing on a local level," says Tim Finnegan, TotalCare Program Director. "This survey will allow participants for the first time to see how they stack up against other local, like-minded companies in terms of the decisions they are making on IT."

Organizations participating in the survey must be headquartered in North Carolina. All survey participants will receive the survey results. To participate, click here.

About TotalCare IT Solutions:
TotalCare IT Solutions, a division of Alphanumeric Systems, Inc., is the leading provider of outsourced IT support services to small and mid sized Triangle based businesses.

The company's proprietary 24x7x365 remote monitoring technology eliminates most computer related issues before they occur, saving clients from downtime and significantly reducing the costs associated with traditional "break/fix" site visits.

TotalCare is the smart, safe and secure solution for growing technology enabled businesses. Over the past 25 years the company has worked with more Triangle based companies than any other local IT company and supports over 10,000 devices for its roster of clients. TotalCare is headquartered in Raleigh, North Carolina and provides IT services to companies from the Triad to the North Carolina coast. For more information, call 919-376-4518 or visit www.TotalCareITSolutions.com.

About NCTA:
The North Carolina Technology Association (NCTA) is a not-for-profit membership-driven trade organization and the primary voice of the information technology industry in North Carolina. NCTA is the intersection of leadership and technology, fueling the growth of North Carolina through Executive Engagement, Public Affairs, and a Knowledge Workforce. For more information, visit www.nc-tech.org

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Submission represents significant milestone and growth potential for Gentris Diagnostics Division as FDA considers the relabeling of a breast cancer drug metabolized by CYP2D6

Research Triangle Park, NC -- (ReleaseWire) -- 10/27/2006 -- Gentris Corporation (Gentris), a leading global provider of applied clinical pharmacogenomic services and diagnostic product solutions, today announced that the company has completed an FDA 510(k) submission for six Human Genomic DNA Reference Controls for the Cytochrome P450 2D6 gene (CYP2D6). Under the GentriSure™ brand, the six products include: CYP2D6 *4A/*2AxN, CYP2D6 *29/*2AxN, CYP2D6 *2M/*17, CYP2D6 *3A/*4A, CYP2D6 *6B/*41 and CYP2D6 *1/*5 Human Genomic DNA Reference Controls.

Roughly 20 percent of all commonly prescribed drugs are known to be metabolized by the liver enzyme, CYP2D6. Approximately seven percent of the U.S. population carries genetic variations of the CYP2D6 gene which could result in unexpected changes in the way patients react, including severe adverse reactions. Recently the FDA made a public announcement that it intends to relabel the breast cancer drug, tamoxifen, because efficacy can be affected in patients with inherited genetic variants that cause deficiencies in CYP2D6. Routine laboratory tests are currently available that can detect CYP2D6 variants to help predict patient outcome before drug treatment. However, without proper controls, the results of these tests cannot be validated and may be unreliable.

Gentris' reference controls are the first commercially available source of well-characterized and consistent genomic material for CYP2D6 testing, obtained with informed consent, and produced under Good Manufacturing Practice (GMP) conditions. Until now, the only reference materials available to the rising number of laboratories performing CYP2D6 diagnostic testing were leftover human specimens, and there are limitations and ethical concerns in using this source of controls. Other control materials are available strictly for research purposes and not of the proper quality required in clinical diagnostic testing. The ideal solution to these dated alternatives, Gentris' reference controls promote necessary standardization across clinical laboratories and facilitate sound proficiency testing.

"Clinical laboratories are now realizing that consistent, properly consented reference controls are just as important in diagnostic testing as the tests themselves," commented Gentris CEO Michael Murphy. "Being the first to file a 510(k) submission for CYP2D6 reference controls is a tremendous milestone for Gentris and came as a direct result of our dedication to innovation and quality in the diagnostic product market. This submission represents the culmination of significant amounts of time, effort and work. We have no doubts that our investment will put us at the forefront of the $2 billion molecular diagnostics market, the fastest growing segment in the clinical laboratory business."

In compliance with strict FDA submission requirements, Gentris conducted user trials at three outside, independent sites to validate the efficacy and quality of these products. The sites included one of the world's largest clinical reference laboratories, a world-renowned reference laboratory for national and international clinics and hospitals, and an independent laboratory spun out of a university that specializes in clinical pharmacogenetic testing. Notably, GentriSure™ Human Genomic DNA Reference Controls were tested on the Roche AmpliChip®, CYP450 Test, the only FDA cleared device for CYP2D6 testing on the market.

Gentris has already identified distributors for GentriSure™ Human Genomic DNA Reference Controls in the U.S and Europe, and is currently seeking distribution partners in Japan. The company anticipates this to be the first of many FDA 510(k) submissions including additional reference controls for other genes such as CYP2C19, CYP2C9 and VKORC1. Currently the GentriSure™ Human Genomic DNA Reference Controls are available for research use.

About Gentris Corporation
Gentris Corporation is a leading global provider of applied clinical pharmacogenomic services and diagnostic product solutions. As pioneers in the field of pharmacogenomics, Gentris helps pharmaceutical companies and clinical research organizations effectively integrate pharmacogenomics into their drug development programs to deliver safer, more effective compounds to the market sooner. Gentris is developing validated reference controls and diagnostic test kits that will bring the promise of personalized medicine to physicians and patients, which will enhance patient management, improve patients' response to therapy and revolutionize medicine through pharmacogenomics. For additional information, please visit http://www.gentris.com.

For more information on this press release visit: http://www.releasewire.com/press-releases/release-3.htm