Quidel this week received 510(k) clearance from the US Food and Drug Administration for its AmpliVue C. Difficile assay.
AmpliVue C. Difficile is a non-instrumented molecular test that combines isothermal helicase-dependent amplification licensed from BioHelix and lateral flow detection technology licensed from Alere in a hand-held cassette format.
Quidel's assay detects toxigenic Clostridium difficile and does not require the use of capital equipment or an upfront nucleic acid extraction step. The company received the CE IVD mark for the test in March (PCR Insider, 3/29/2012).
Spartan Bioscience this week announced the commencement of a 5,945-patient study for the use of its rapid DNA testing technology for personalized therapy in cardiac stent patients.
The study, sponsored by the Center for Individualized Medicine at the Mayo Clinic, is entitled "Tailored Antiplatelet Initiation to Lessen Outcomes due to Clopidogrel Resistance after Percutaneous Coronary Intervention, or TAILOR-PCI.
The trial will evaluate whether genotyping cardiac stent patients at the time of angioplasty can help improve patient outcomes by informing providers about drug selection of either ticagrelor, marketed by AstraZeneca as Brilinta; or clopidogrel, marketed by Bristol-Myers Squibb and Sanofi-Aventis as Plavix.
These antiplatelet drugs are prescribed after surgery to reduce clotting complications, such as heart attacks, strokes, and cardiovascular deaths. The drugs are thought to work differently in patients with specific variations in the CYP2C19 gene, and the Spartan RX CYP2C19 rapid DNA testing system will be used to identify these variations in some patients of the TAILOR-PCI study. The study will enroll patients over a 22-month period at nine hospitals in Canada and the United States.
Spartan RX is a fully automated, point-of-care PCR-based testing platform that the company claims can complete a genetic test such as the CYP2C19 assay in an hour or less.