Genoptix, which is placing itself at "the forefront of personalized medicine," recently received its clinical laboratory license from the California Department of Health Services to offer "[Clinical Laboratory Improvement Amendment]-compliant, high-complexity medical testing services for certain blood and lymph system cancers."

Founded in 2000, Genoptix, of San Diego, has spent the last three years developing its assay technologies with the goal of offering a range of services to help physicians determine the best medicines for patients.

"We're trying to offer a total [disease] management package," said Tina Nova, president and CEO of Genoptix. "So, it's a really different approach than just offering pieces of the assays together. We can help the physician from the beginning, through the treatment, through the monitoring and back around again, [often because] these patients relapse and have to be re-treated."

The American Cancer Society in Atlanta projects that in 2004 nearly 100,000 new cases of leukemia, non-Hodgkin's lymphoma and multiple myeloma will be diagnosed, Genoptix said.

While Nova said that there's "no question" that other companies have genetic markers to help identify individuals likely to develop diseases and how best to treat them, Genoptix operates more specifically at the cellular level of disease.

And she believes that personalized medicine will continue to grow.

"As drugs become more personalized, the need for diagnostics to become more personalized is going to increase over time," she said.

Toward that end, Genoptix, she said, has developed its technology in "two tracks" - the CancerTrax test, launched a month ago, and the OptoTrax test, still awaiting CLIA approval.

The CancerTrax test is used to evaluate patients' reactions to different chemotherapeutic agents plus monoclonal antibodies. CancerTrax uses polymerase chain reaction and flow cytometry in its assays, which typically test a blood sample against about seven drugs, including Rituxan, to measure for resistance.

Like CancerTrax, OptoTrax also can be used to identify the best medicine for certain cancer patients.

Genoptix said that the addition of monoclonal antibodies being used with certain chemotherapeutic agents has made selection of the right drug for the right patient that much more important.

Mike Nerenberg, company laboratory director, said CancerTrax derives from the work of Andrew Bosanquet, of Bath, UK, who has about 20 years of experience in treating liquid tumors, leukemias and lymphomas. A test built on his work has been developed and used in Europe, but to a lesser degree in the U.S., Nerenberg said. Data from studies on the tests have been published in the Journal of Hematology in the UK.

"The overall accuracy of prediction of resistance [to certain drugs] is about 93 percent; sensitivity is a little less, about 73 percent," Nerenberg said. "What's striking about it is when patients are treated with drugs they are resistant to, they do very badly. And I think it's a big surprise to hematologists how badly they do."

Also, Nerenberg pointed to the necessity of the first drug a patient receives being the right one. He gave as an example the traditional philosophy related to chronic lymphocytic lymphoma (CLL). It's considered a disease of the elderly and not curable. Therefore, the goal becomes improving the patient's quality of life. Typically, Nerenberg said, patients are treated sequentially with several drugs to the point that they ultimately become resistant to all of them.

His conclusion is that "the first drug that [a physician comes] out of the box with is the important drug."

"You want it to work," Nerenberg said, adding that he believes that "there is enough scientific information to allow one to make highly personalized choices of therapy and management."

So, Genoptix offers a suite of services, including predictive and prognostic testing to allow physicians to assess patients and put them into different risk groups, he said.

For example, Genoptix uses six-color flow cytometry for directed phenotyping and can provide characterization of marker expression for prognostic information in CLL and quantitation of minimal residual disease in CLL and acute myelogenous leukemia.

Genoptix, which has raised about $35 million to date, is just getting under way with CancerTrax, Nova said, adding that the company is using a small sales force and publications to validate the CancerTrax assay and back its applications in the clinical setting. So far, it is "getting some nice traction in the marketplace," Nova said.

"Our strategy is to support the company through sales and through corporate partnerships for the next phase until we break even," she said.

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