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Rheonix Plans FDA Submission for Warfarin Sensitivity Test

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – Rheonix today said that it intends to file for US Food and Drug Administration clearance for its warfarin sensitivity test on its CARD platform.

The Ithaca, NY-based startup said that it intends to file a 510(k) application for the test, which detects three SNPs — VKOR1, CYP2C9*2, and CYP2C9*3 — associated with warfarin sensitivity.

The test was one of three that the firm presented in posters at the American Association for Clinical Chemistry meeting being held this week in Anaheim, Calif. The other posters detailed results of studies on tests for human papillomavirus and sexually transmitted infections. The HPV test detects and identifies 20 clinically relevant HPV types, while the STI test identifies N. gonorrhoeae, C. trachomatis, T. pallidum, and T. vaginalis in a multiplex assay.

Rheonix's CARD (Chemistry and Reagent Device) system is a microfluidic platform that fully automates all the functions of a molecular biology lab on a small disposable chip. It includes raw sample preparation, molecular amplification, and multiplex analysis and enables end users to automate new or existing assays using single or multiple raw clinical samples.

"The rapid advancement of the molecular diagnostics industry is driving the need for new, cost-efficient platforms that can be rapidly customized to perform single or multiplex diagnostic assays across a broad range of applications with minimal operator intervention," Rheonix President Tony Eisenhut said in a statement. He added that the posters presented at AACC demonstrate that the system "can achieve industry gold standard accuracy in important clinical applications."

Earlier this, Rheonix raised $12.6 million in a Series A round of financing.