Medicare Awards Coverage to Molecular Breast Cancer Test From BioTheranostics

BioTheranostics’s Breast Cancer Index test has received Medicare coverage, making it the only molecular test covered by Medicare that assesses a patient’s risk of late distant breast cancer recurrence and identifies which patients will benefit from extended hormone therapy. The Centers for Medicare and Medicaid Services posted a positive coverage and reimbursement policy after evaluation by Palmetto GBA, the Medicare administrator responsible for the MolDx molecular diagnostic technology assessment program. This policy covers use of the test to predict risk of breast cancer recurrence after 5–10 years in women with early stage, estrogen receptor-positive breast cancer who are considering extended endocrine therapy but are concerned about its documented toxicity or possible patient-specific side effects. About two-thirds of breast cancer patients are estrogen receptor-positive, and the risk of late distant recurrence in these women is a substantial concern, with more than 50% of recurrences arising after 5 years.

In addition to new claims, Medicare coverage and payment for the Breast Cancer Index test will be made retroactively for previously submitted claims. The Medicare coverage decision was based on a review of the scientific evidence supporting the analytical validity, clinical validity, and clinical utility of the test. It is one of the first coverage determinations for a molecular cancer diagnostic technology handed down by the rigorous evaluative process implemented by Palmetto GBA since the inception of MolDx in 2011.

Two BioFire Ebola Tests Receive Emergency Use Authorization From FDA

The Food and Drug Adminis­tration (FDA) has granted Emergency Use Authorization to BioFire Defense for its commercial FilmArray Ebola test—the BioThreat-E test—as well as for a second Ebola test to be used by laboratories designated by the Department of Defense. The FilmArray BioThreat-E is the first commercial Ebola test to be authorized for emergency use on patients with signs and symptoms of Ebola Zaire virus infection in conjunction with epidemiological risk factors. It is available to high and moderate complexity clinical laboratories in the U.S. and can be run on any existing BioFire FilmArray system, which is in routine use in more than 300 hospitals. Previously cleared by FDA, the FilmArray system is a PCR-based diagnostic device that can identify pathogens in 1 hour, enabling health professionals to make rapid treatment decisions.

The BioThreat-E test has not received FDA clearance or approval, and is only authorized for the duration of the declaration that circumstances exist justifying emergency use tests for the detection of Ebola Zaire virus.

Abbott Granted CE Mark for Molecular Tuberculosis Test

Abbott has received CE mark approval for a molecular diagnostic test for the detection of Mycobacterium tuberculosis (MTB), which causes tuberculosis. Tuberculosis continues to be a major public health threat, with the World Health Organization estimating that 8.6 million people developed the disease in 2012. Of these, an estimated 1.1 million are also HIV-positive, due to the fact that individuals with compromised immune systems are at a higher risk of developing TB. Abbott’s MTB test is performed on the automated m2000 molecular diagnostic testing system and consolidates HIV-1 and MTB tests on the same platform. Abbott intends for this test to help reduce the global burden of infectious diseases in high prevalence areas like Africa, where 75% of TB-HIV co-infections occur. Additionally, an MTB inactivation step is included with the test procedure to reduce the risk of infection caused by airborne exposure to MTB during handling of sample material.

FDA Clears Quidel Adenovirus Assay

Quidel Corporation has received FDA clearance for its Lyra Adenovirus assay, a real-time PCR test for the qualitative detection of human adenovirus DNA isolated from nasal swab and nasopharyngeal swab specimens. Adenovirus infections can cause several illneseses and symptoms, such as colds, sore throat, bronchitis, pneumonia, diarrhea, pink eye, and fever.

Quidel’s Lyra Adenovirus assay is part of the company’s new Lyra brand of ready-to-use, molecular PCR reagent kits that are designed to be compatible with a laboratory’s existing thermocycler. These kits provide ready-to-use master mix and refrigerated storage of key reagents, in addition to yielding quantitative PCR results within 75 minutes.

Nanosphere Enteric Pathogens Test Receives FDA Clearance for New Viral Targets

FDA has cleared new viral targets for Nanosphere’s Verigene Enteric Pathogens Nucleic Acid test (EP) in addition to the bacterial and toxigenic targets the agency cleared earlier this summer. Verigene EP is a rapid alternative to traditional stool diagnostics that has the potential to reduce the use of unnecessary or inappropriate antibiotics by enabling clinicians to make informed patient treatment decisions earlier. Designed on the Verigene system, it uses Nanosphere’s core proprietary gold nanoparticle chemistry to offer highly sensitive, highly specific molecular diagnostic results through multiplexing, and detects infectious pathogens and drug resistance markers by targeting conserved genetic regions of a bacterium or virus.

Beckman Coulter Gets FDA Nod for Automated Sample Processing System

FDA has granted Beckman Coulter 510(k) clearance for its Power Express high-speed automated sample processing system, which processes samples for all core disciplines: chemistry, immunoassay, hematology, and coagulation. The Power Express provides connected automation by combining Beckman Coulter’s AU clinical chemistry system, the UniCel Dxl 800 immunoassay system, and third-party connection capabilities, including coagulation. The company also plans to include hematology solutions in the system later this year.