By Allan Maurer

MORRISVILLE, NC—Gentris, a small Morrisville company working on tests that will help usher in the era of personalized medicine, recently gained U.S. Food and Drug Administration approval of its first set of products only three months after applying. That’s something of a validation for the Gentris strategy of focusing on areas where the FDA itself has said there’s a pressing need.

With its infrastructure and a pipeline of products in development, “2007 will be a breakout year for Gentris,” says CEO Michael Murphy. Murphy says building a Good Manufacturing Practices facility was the real challenge. FDA regulations for a GMP facility run to well over 100 pages. “People literally worked 24 hours a day,” he notes. But now that the company has that hurdle out of the way, “The rest should flow fairly easily out of our infrastructure,” he says.

The FDA approved GentriSure, the first six of its set of products that act as controls when testing how a patient reacts to commonly used drugs. Genetic differences make some people process drugs much more quickly or much more slowly than others. This can lead to bad drug reactions, which kill an estimated 100,000 people a year in the United States and injure more than 2 million people annually according the American Medical Association. Solving this problem is an FDA priority.

GentriSure controls are used with tests for a liver enzyme called CYP2D6, which helps metabolize about 20 percent of commonly prescribed drugs. “Up until now, no one paid attention to the reference control,” Murphy says. “But since you have to have a control for all the tests in the diagnostic lab, you can’t do one without the other. We saw that as a unique opportunity.”

Following the FDA’s lead

Murphy points out that Gentris is developing tests that have an assured market.

“We’re basically following the FDA’s lead.” The company, he explains, develops products for genetics tests the FDA mandates in an effort to prevent bad drug interactions. When genetic tests are required by the FDA, insurers generally cover the cost. “If there isn’t a government mandate for the test, you’re probably not going to have a good market,” Murphy says.

Blockbuster test coming

The company is developing a test for Warfarin, which keeps blood from clotting. The FDA is expected to mandate genetic testing for those prescribed the drug in 2007. “It’s one of the most commonly used drugs in the United States,” says Murphy. “Thirty million people use it, 10 percent of the population, 10 million new prescriptions each year.”

Warfarin is used to treat heart attacks and strokes, help prevent clots following heart valve replacement, and as the primary treatment for deep vein thrombosis, which often affects people who travel a great deal in cars.

People who take Warfarin are tested daily the first week. About 1 percent of the population does not have the proper liver enzyme to break it down, so it accumulates with each dose. About 11 percent have a genetic mutation that can cause a similar but less severe problem. Overdosing causes internal bleeding.

Gentris geared up to start clinical trials on its genetic tests for Warfarin this month. “Our test is designed to use blood or saliva with a 30 minute turnaround time.” Tests currently made by competitors take at least four hours. “This will be our first real blockbuster test because of the urgent need,” Murphy says.

He says the Gentris product should be cleared by the FDA by the third quarter this year.

The company has numerous other tests in its pipeline. “Our advantage,” Murphy says, “is that we’re not a platform technology company. We’re not constrained to using any particular tech. We choose the one that works fastest and most accurately for each particular test.”

Gentris, which raised a $8.1 million in four rounds, and is seeking an additional $10 million in venture capital to accelerate development of its Gentris Diagnostics pipeline. The company has 35 employees and two units.

Its clinical genetics service unit has produced a revenue stream since 2002.

For more information see: www.gentris.com

TechJournal South Editor Allan Maurer can be reached at: allan@techjournalsouth.com

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