This Week In Diagnostics

Quidel receives FDA clearance for its Influenza A+B assay

Quidel Corp. (NASDAQ: QDEL) reports that it has received 510(k) clearance from the FDA for its Molecular™ Influenza A+B Assay for the detection of influenza A and B for use with Cepheid’s SmartCycler® PCR system. Quidel received FDA clearance in December to run its Quidel Molecular Influenza A+B and hMPV assays on Life Technologies’ Applied Biosystems® 7500 Fast DX thermocycler.

The product was launched in Europe for use with both thermocyclers shortly after receiving the CE Mark in August 2011.


Ariosa completes study for prenatal test

San Jose, Calif.-based Ariosa Diagnostics (formerly Aria Diagnostics), says that it has completed a clinical validation study for the Harmony™ Prenatal Test. The test utilizes a directed, non-invasive approach to cell-free DNA (cfDNA) analysis in maternal blood. The company will be providing details about their proprietary biochemistry and algorithm platforms, which work together to analyze patient samples in order to provide individualized risk scores at the 2012 American College of Medical Genetics (ACMG) Annual Clinical Genetics Meeting in Charlotte, N.C.


Clearbridge BioMedics  launches its ClearCell system

Clearbridge BioMedics is reporting that it has achieved ISO13485 certification for the development of cell-based in-vitro diagnostic devices and has launched its ClearCell™ System, for the cancer research market. The company says that it is one of the world’s first commercially-available systems that can successfully isolate circulating tumor cells (CTC) from blood, using biomechanical properties. The system can retrieve intact and viable CTCs in their native states, without the use of antibodies or magnetic beads. This will enable cancer researchers to better understand the relationship between such cells and mechanisms of cancer. The ClearCell™ System will be showcased at the American Association for Cancer Research annual meeting, from March 31 to April 4, 2012 in Chicago.


Statins compliance in patients linked to knowledge of gene test results

According to a study there is evidence that genetic tests can influence behavior, as well as helping physicians more accurately diagnose and treat disease.  Patients who are told of their test results are more motivated to regularly take and stay on medications to treat high cholesterol.  The results of the Additional KIF6 Risk Offers Better Adherence to Statins (AKROBATS) study was presented by investigators from the Medco Research Institute™, a subsidiary of Medco Health Solutions, Inc. (NYSE: MHS) and Quest Diagnostics (NYSE: DGX), at the American College of Cardiology’s 61st Annual Scientific Session & Expo.

The study examined medication adherence of 1,294 patients that were newly prescribed statins.  A laboratory-developed gene test to measure kinesin-like protein 6 (KIF6) carrier status was provided to 647 patients while 647 patients in the control group did not receive a genetic test.  The two groups were matched for age, gender, prescription distribution channel, and the number of chronic medications used.  After controlling for other patient characteristics known to affect adherence (such as co-morbidities and socioeconomic status), tested patients who were informed of their test result had significantly higher overall adherence to their statin treatment as measured by the proportion of days with medication on hand over a six-month period, the study’s primary end point (77 percent of days covered versus 68 percent).

 -Peter Winter

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