This article has been updated from a previous version to clarify statements from a TrimGen official about the company's expectations regarding FDA approval for its test. The company said that it has not yet received official notification from the FDA, and that it expects the test to clear in the near future, rather than by the end of the month, as the firm previously stated.
NEW YORK (GenomeWeb News) - TrimGen expects the US Food and Drug Administration to clear as an in vitro diagnostic its warfarin-dosing test “in the near future,” James Doherty, TrimGen product specialist, told GenomeWeb Daily News sister publication Pharmacogenomics Reporter this week.
Maryland-based TrimGen, which submitted its 510(k) application for the eQ-PCR LightCycler Warfarin Genotyping Kit in December 2007, said it plans to differentiate its test from rivals’ products based on its 1.5-hour turnaround and relative ease of use.
TrimGen has looked at the clinical and analytical validity of the test in a 170-patient study at three sites. Doherty said the diagnostic, which is based on Roche's eq-PCR LightCycler platform, had 100 percent agreement with bi-directional sequencing.
TrimGen also markets the Mutector II Warfarin Genotyping Test kit, a homebrew that analyzes samples using an Applied Biosystems capillary sequencer.
If cleared, the company’s LightCycler warfarin test will be the fifth such product to win regulatory approval in the US behind those made by ParagonDx, AutoGenomics, Nanosphere, and Osmetech. There are also several homebrew assays marketed by Laboratory Corporation of America, Idaho Technology, and Clinical Data, among others.
TrimGen’s test is designed to detect what are generally believed to be the most clinically relevant genetic variations responsible for patient sensitivity to the anticoagulant: the CYP 2C9*2 (C430T), 2C9*3 (A1075C), and VKORC1 (-1639 G>A) mutations.
However, there are several competing products on the market that offer testing for other mutations. For instance, Genelex’s homebrew Warfarin Target Dose Safety Test, based on Luminex Molecular Diagnostics’ Tag-It Universal Array platform, gauges CYP 2C9 *2, *3, *4, *5, *6, and VKORC1 (-1639 G>A) mutations. Nanosphere’s FDA-approved Warfarin Metabolism Nucleic Acid Test gauges CYP 2C9 *2, *3, as well as VKORC1 (-1639 G>A) and (1173C>T).
Meanwhile, AutoGenomics boasts that its INFINITI assay detects 15 2C9 and VKORC1 variants, more than any other company in the market. Among the 15 variants the Infiniti assay detects, several polymorphisms will be specific to particular ethnicities – such as the *4 variant identified exclusively among Japanese people and the 8,773 SNPs in VKORC1 found in 21 percent of African Americans.
A more comprehensive version of this article appears in this week's issue of Pharmacogenomics Reporter.