• Cambridge Heart (Bedford, Massachusetts) reported the publication of a proposed decision memorandum regarding Medicare coverage of Microvolt T-wave Alternans (MTWA) diagnostic testing. The Centers for Medicare & Medicaid Services maintained coverage of MTWA using the spectral analysis method and found insufficient evidence for coverage of MTWA using any other method. The proposed decision memorandum is the result of CMS’ six-month evaluation of the relevant clinical evidence available to the agency and consideration of public comments submitted on the request to expand coverage to include the Modified Moving Average methodology. The memorandum proposes to continue the existing coverage of MTWA with spectral analysis.

• Focus Diagnostics (Cypress California) reported the first laboratory-developed test in the U.S. for detecting the mosquito-borne chikungunya virus. Commercial availability of the molecular polymerase chain reaction (PCR) test will enable physicians in the U.S. to test patients who may have contracted the virus, such as individuals returning from regions in Africa and Asia where chikungunya is endemic. The chikungunya virus test is a molecular assay that employs PCR, a highly sensitive and commonly used testing method that can detect the presence of the virus’ RNA in a patient’s blood. Physicians can use test results in conjunction with clinical symptoms to diagnose a patient’s infection with the virus. Until now, testing for chikungunya virus was not commercially available in the U.S. and specimens were referred to a public health laboratory, which could take a week or more to report results. Focus Diagnostics expects to be able to provide physicians with test results within a day of receiving a sample for testing. Focus Diagnostics is an infectious disease diagnostics company.

• OrbusNeich’s (Hong Kong) Genous bio-engineered R stent is feasible and safe for use in acute myocardial infarction (AMI) patients, according to a paper published in the American Heart Journal. Unlike drug-eluting stents, Genous, which is coated with an antibody, captures a patient’s endothelial progenitor cells (EPCs) to accelerate the natural healing process. EPCs circulate in the bloodstream and are involved in the repair of blood vessels. When attracted to the surface of Genous, EPCs rapidly form an endothelial layer over the stent that provides protection against thrombus and minimizes restenosis. OrbusNeich makes medical devices for the treatment of vascular diseases.