Put It on the Board, 9/16

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Alere’s RSV test cleared

The FDA has given Alere 510(k) marketing clearance for its point-of-care test to detect respiratory syncytial virus infection in children and adults. The RSV test is the latest offering on the Alere i platform and is the first molecular test that can be used at the point of care to detect RSV in 13 minutes or less, the company said.

Alere said it will soon submit an application for CLIA waiver of its RSV test. Alere i testing applications for streptococcus A and influenza A and B are CLIA-waived.

Alere’s RSV test detects the virus in nasopharyngeal swab samples using the company’s isothermal nucleic acid amplification technology. Alere said the test is faster than conventional PCR tests. In clinical performance studies, the overall sensitivity and specificity of the i RSV using direct NP swab samples was 98.6 percent and 98 percent, respectively, versus PCR. With viral transport media samples, the sensitivity and specificity of the i RSV was 98.6 percent and 97.8 percent, respectively, versus PCR.

The Alere i RSV test will be available for use in hospitals in time for the 2016–2017 flu and respiratory illness season.
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HHS announces $15.5 million for rapid Zika tests

The Department of Health and Human Services in August announced separate funding agreements with OraSure Technologies, Chembio Diagnostic Systems, and DiaSorin Group aimed at speeding the development of Zika diagnostic tests.

Nearly half of the money, $7 million, will go to OraSure, of Bethlehem, Pa., to help the company develop a point-of-care test. The HHS will provide the funding over the next three years to support the product’s continued development, manufacturing preparations, and the clinical testing needed to apply for clearance from the FDA.

The agency has the option to fund additional work through 2022 for as much as $16.6 million total to OraSure. During development, the company also could request that the FDA issue an emergency use authorization for the lateral-flow serological test.

Chembio Diagnostics, of Medford, NY, also is developing a POC lateral-flow serological test and will get $5.9 million from the HHS over the next year. That contract could be extended for up to three years and a total of $13.2 million.

DiaSorin Group, based in Italy, will get $2.6 million for work on an automated laboratory test for its Liaison XL system. That platform can test up to 120 samples at a time and generate results within an hour.
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MammaPrint may help more women avoid chemo

Agendia announced the primary outcome results of the MINDACT clinical trial, which demonstrated that 46 percent of breast cancer patients with tumors classified as low risk by the MammaPrint 70-gene signature have excellent survival without chemotherapy and can thus be candidates to forgo it.

Of the 6,693 patients in the trial, 23.2 percent were deemed to have high clinical risk and low genomic risk. Among these patients, the ones who skipped chemotherapy had a five-year survival rate without distant metastasis that was 1.5 percentage points lower than that of similarly risk-stratified patients who did receive chemotherapy (Cardoso F, et al. N Engl J Med. 2016;375[8]:717–729).

In a NEJM editorial, Memorial Sloan Kettering oncologists Clifford Hudis, MD, and Maura Dickler, MD, commended the MINDACT trial’s efficient research model but said the study’s result is “statistically underpowered.” The survival “difference does not precisely exclude a benefit that clinicians and patients might find meaningful,” they added.[hr]