warfarin genotyping

While past studies that have attempted to gauge the clinical utility of warfarin PGx testing have been hampered by slow test turnaround times, Iverson is promising to provide genetic test results within 24 hours.

The study found that when doctors and their patients were educated about PGx-guided dosing for warfarin and tamoxifen in a pharmacy-initiated personalized medicine program, the testing rate increased 45-fold for warfarin and seven-fold for tamoxifen.

Although some industry observers suggest that Boehringer Ingelheim's newly FDA-approved anticoagulant spells the end for PGx-guided warfarin dosing, some still see opportunities where warfarin administration, made more accurate with genetic testing, may be a better option for patients.

Fluimedix is developing a diagnostic test for warfarin metabolism on the NanoCycler, its benchtop, PCR-based diagnostic platform.

At AACC, Rheonix presented three research studies demonstrating its integrated sample prep and PCR testing platform. In addition, the company reiterated its intent to seek regulatory clearance in the US for a warfarin sensitivity genotyping test by the end of the year; followed by a regulatory submission in China for an HPV test.

The firm intends to file for FDA clearance of the test, which would run on its CARD molecular diagnostics system.

The two-year study will assess the impact of genetic information on determining warfarin dosage and changes in the rate of adverse events when beginning a warfarin treatment regimen.

The company will use the cash to continue developing in vitro diagnostic assays for its "chemistry and reagent device," or CARD — which integrates sample preparation, nucleic acid amplification, and endpoint detection all on a single microfluidics-based, point-of-care polymeric module.

The Genetics Informatics Trial of Warfarin will apply new PGx algorithms to investigate the utility of genetic testing in the orthopedic population.

According to the agency, ParagonDx's ASR probes for gauging the presence of CYP2C9*2, CYP2C9*3, VKORC1 1173, VKORC1 3730 variants "are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body."

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