The firm said that its test is the first on the market to detect RSV infection at the point of care in 13 minutes or less.
The firm wants to develop a test that can provide objective, reliable, and rapid information so that clinicians can make critical decisions in circumstances of high uncertainty.
The FDA granted Abbott Emergency Use Authorization for the assay in serum, plasma, and urine in November.
Companies with diverse infectious disease diagnostic technology offerings said that molecular methods are complementary to, not competitive with traditional diagnostics.
Abbott's commitment to closing the deal is still uncertain, but Alere's CEO said the regulatory clearance marks a "significant milestone."
Separately, Alere said today that the European Commission has granted clearance for its acquistion by Abbott.
Mergers and acquisitions in the omics space rose for the second year in a row, but the increase was significantly less than the 33 percent uptick in 2015 deals.
Alere said its would-be acquirer has no grounds for seeking termination, but Abbott cited adverse material events as a basis for ending the deal.
The GenomeWeb Index, which fell nearly 9 percent in October, rebounded to a 1 percent gain in November, but still underperformed the Dow and Nasdaq.
The CDC noted that if the test yields a negative RNA NAT result, clinicians should then analyze patient serum using an IgM antibody test.
The former commissioner of the FDA has returned to the venture capital firm New Enterprise Associates as a special partner on the healthcare investment team.
Astronauts have edited yeast genes on the International Space Station in an experiment designed to show how cells repair themselves in space.
Emory University has found that two of its researchers failed to divulge they had received funds from China, according to the Atlanta Journal-Constitution.
In Science this week: influence of the nuclear genome on human mitochondrial DNA, and more.