Released on = October 26, 2006, 7:10 am

Press Release Author = Gentris Corporation

Industry = Biotech

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

Press Release Body = Research Triangle Park, North Carolina - October 26 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 GentriSureT 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, GentriSureT 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 GentriSureT 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 GentriSureT 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.

Web Site = http://www.gentris.com.

Contact Details = Jonathan Jordan
press@gentris.com
919 Marketing/919-557-7890