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AutoGenomics' Warfarin Test Approved

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AutoGenomics announced that the US Food and Drug Administration approved its Infiniti Warfarin XP dose-response assay for identifying patients with CYP450 2C9 and VKORC1 genetic variants.

The company, based in Carlsbad, Calif., submitted the assay to the FDA for 510(k) approval last December. The test runs on its Infiniti platform, which the FDA cleared for multiplex testing earlier this year.

AutoGenomics is entering a crowded market. Four months ago, the FDA approved Nanosphere's Verigene Warfarin Metabolism Nucleic Acid Test, which runs on the company's Verigene platform. There are also several companies, such as Clinical Data, LabCorp, Genelex, and Nanogen that market homebrew tests for this indication.
But Autogenomics' test has several points that differentiate it from these rivals, the company says. For one, its warfarin panel was validated by the Harvard Medical School-Partners HealthCare Center for Genetics and Genomics. HPCGG also used AutoGenomics' assay in the "CReating an Optimal Warfarin Nomogram," or CROWN, trial, a prospective study that used genetic tests to determine optimal warfarin dosing.
According to AutoGenomics, there can be more than a 10-fold dosing variability among patients on warfarin. The Infiniti 2C9-VKORC1 panel "has the potential to optimize warfarin dosing and lower the risk of bleeding complications," Raju Kucherlapati, HPCGG scientific director, has said of the assay.

In addition to being validated by independent researchers, the assay is able to test for variants that no other marketed test can assess. Most marketed warfarin assays test for CYP239*2 and *3 variants, and VKORC1 variant 3673 (-1639G>A).
The Infiniti assay tests for those variants plus CYP239 *4, *5, *6, and *11, as well as VKORC1 variants 5808, 6009, 6484 (1173C>T), 6853, 7566, 8773, and 9041(3730G>A). Clinical studies have linked some of these variants to warfarin sensitivity in certain ethnic populations, such as Japanese and African-American.

— Turna Ray

PGx & Molecular Dx Notes

Three soon-to-be published studies suggest that a polymorphism in KIF6, a gene encoding a kinesin-like protein in the molecular motor family, increases the risk of coronary heart disease. Celera subsidiary Berkeley HeartLab is developing a laboratory test, which it expects to launch soon, for the gene variant.

Four papers on lupus genetics, including two large genome-wide SNP studies, one investigating SNPs that specifically predict amino acid changes and one focusing on a particular candidate gene, shed light on the molecular pathways implicated in the disease. The papers appeared in Nature Genetics and the New England Journal of Medicine.

The Canadian government licensed Cepheid's test for methicillin-resistant Staphylococcus aureus for use in hospitals.

Datapoint

$2.5 million
Value of NIH grant funding an initiative pairing the Cancer Institute of New Jersey and IBM to develop diagnostic tools.

Funded Grants

$162,918/FY2007
Molecular Targeted Imaging in Colon Cancer
Grantee: Joseph Backer, SibTech
Began: Sep. 28, 2007; Ends: Mar. 31, 2008
According to the abstract, Backer and his colleagues plan to optimize detection of colorectal lesions via VEGFR-mediated fluorescent imaging and establish the feasibility of early detection of colorectal lesions with scVEGF/Cy tracer. If all goes well, this work could lead to the clinical development of a new imaging tracer for early diagnosis of prostate cancer.

$471,753/FY2007
Biomarker signatures of biological, chemical, or psychological stress
Grantee: David Lawrence, Wadsworth Center
Began: Aug. 15, 2007; Ends: May 31, 2011
Lawrence will study patients with sepsis or rheumatoid arthritis as a prototype of stressed individuals to identify and quantify the presence of serum proteins that have increased, decreased, or which display epitope-modified expression, according to the abstract. These molecular features will form the basis of specific biomarker signatures characteristic of people under stress.

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