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FDA, Celera and Merck, Nanogen, and Ipsogen and Xenomics

FDA Clears First Warfarin Sensitivity Test from Nanosphere
The US Food and Drug Administration this week cleared the first test to detect gene variants in patients that are sensitive to the anticoagulant warfarin. The test is made by Northbrook, Ill.-based Nanosphere.
"Today’s action offers physicians the first FDA cleared genetic test for warfarin sensitivity, which is another step in our commitment to personalized medicine,” said Daniel Schultz, director of FDA’s Center for Devices and Radiological Health, in a statement. “With this test, physicians may be able to use genetic information along with other clinical information to treat their patients.”
Warfarin, marketed as Coumadin by Bristol-Myers Squibb, is used to prevent potentially fatal clots in blood vessels. However, too much or too little of the drug in patients can cause serious, life-threatening bleeding or blood clots. Variability to warfarin response has been linked to mutations in two genes: CYP2C9 and VKORC1.
Nanosphere’s Verigene Warfarin Metabolism Nucleic Acid Test, which runs on the company’s Verigene platform, “detects some variants of both genes,” the FDA said in a statement.
The agency cleared the test based on results of a study conducted by Nanosphere of “hundreds of DNA samples as well as on a broad range of published literature.” In a three-site study, the test was “accurate in all cases where the test yielded a result,” the FDA said. However, approximately 8 percent of the tests could not identify which genetic variants were present.
In August, FDA updated labeling [see PGx Reporter 9-5-2007] for warfarin with information explaining that people with variations of the genes CYP2C9 and VKORC1 may respond differently to the drug.
The agency, however, stopped short of requiring physicians in the label to genetically test their patients, noting that additional outcomes studies needed to be done.
“The Nanosphere test is not intended to be a stand-alone tool to determine optimum drug dosage, but should be used along with clinical evaluation and other tools, including [International Normalized Ratio], to determine the best treatment for patients,” the FDA said.
While Nanosphere is the first company to receive FDA approval for a warfarin test, it is not the only company with a product in this area. Kimball Genetics last year launched a warfarin sensitivity DNA test for research purposes, while Nanogen, Genelex, AutoGenomics, and Clinical Data each market home-brew warfarin tests of their own. Other companies, such as Osmetech and ParagonDx, have announced plans to develop their own tests in this area.

Celera to Develop Dxs for Merck Cancer Trials That Could Become Companion Tests
Celera said this week it will collaborate with Merck & Co. to develop molecular diagnostics for the drug maker to use in its clinical trials, which could potentially be used as companion diagnostics for Merck’s cancer drugs.
Terms of the deal, which is expected to wrap up at the end of Celera’s fiscal year 2008, call for the Applera unit to create assays based on gene-expression profiles that Merck identifies.
Celera said it will collect an undisclosed payment for its work in the collaboration, and will receive another payment if Merck opts to transfer one of Celera’s validated tests to a clinical reference lab, Celera said.

Nanogen Mulls Sale or Closure of Microarray Business in Bid to Focus on Clinical Dx
Nanogen said this week that it is looking for ways to exit its microarray business as part of a plan to achieve profitability and focus on its clinical diagnostics strategy.
The company said it has hired Credit Suisse to help evaluate its options, “which may include a sale, partnering, or closure of the array business.”
Nanogen said it expects to complete the evaluation of the array business, which includes its NanoChip instruments and related reagents and consumables, within sixty to ninety days.
The company expects that the sale or closure of the microarray business will decrease expenses and improve cash flow by at least $15 million per year.
Robert Saltmarsh, Nanogen’s CFO, said that if the company sells or closes the segment, “the restructured business will show revenue growth on a year-over-year basis.”
Nanogen said it plans to continue to focus on the clinical diagnostic market, with an “emphasis on real-time molecular and rapid point-of-care products."
Howard Birndorf, Nanogen CEO, said in a statement that despite “positive“ customer reception for its microarray product line, “multiplex molecular testing remains an early-stage market with slower growth and lower testing volumes than we expected."
He added, “The cost and effort to develop the broad product menu needed to be successful while also working to develop the clinical market over the next several years are large efforts and are expenses that Nanogen can no longer afford on its own.”
The plan follows several recent moves Nanogen has taken to augment its working capital, including a $50 million shelf offering in May and a $20 million convertible debt registered offering in August.

Ipsogen Licenses Xenomics’ IP to Develop AML Dx
Ipsogen said this week it has co-exclusively licensed a biomarker from Xenomics linked to acute myeloid leukemia in order to develop and sell tests for the disease.  
Ipsogen’s diagnostics, which will be designed to stratify and monitor AML patients, will be based on NPM1 mutations that will integrate Ipsogen’s quantitative and standardized technology, including its FusionQuant and ProfileQuant tools, according to a statement.
“With this acute disease, physicians need a rapid assessment of patient prognosis for effective use of chemotherapy,” Xenomics CSO Samuil Umansky said in a statement.
He added that NPM1 “provides an excellent test for monitoring the minimal residual disease and patients in response to anti-tumor therapy.”

Financial terms of the agreement were not released.

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