Alere's new HIV test could gain momentum from Affordable Care Act

If timing is everything, then Alere ($ALR) stands to gain plenty, thanks to the Affordable Care Act. The new law mandates reimbursement for HIV testing from both public and private insurers, and the diagnostics and patient monitoring company recently rolled out a new, first-of-its-kind combo HIV diagnostic in the U.S.

Dubbed the Alere Determine HIV-1/2 Ag/Ab Combo test, it is a rapid point-of-care diagnostic designed to detect both HIV-1/2 antibodies and the HIV-1 p24 antigen--the first immunoassay of its kind to do so. It's a big advance as far as HIV diagnosis, as the test allows for far earlier detection of HIV, considering that the HIV-1 p24 antigen makes itself known well before HIV-1/2 antibodies. Alere won FDA approval in August, and regulators themselves announced the milestone because of the novelty.

For now, Alere's marketing efforts are focused on slow but deliberate growth for the test. Joe Medeiros, director of marketing for Alere's North America Virology Solutions division, told FierceDiagnostics via email that the company's sales force "has been extensively trained on the product and the disease state" and "are actively promoting" the test "to decision-makers within healthcare facilities."

Medeiros wouldn't comment on how much the in vitro test costs, but said it is "priced responsibly and competitively" compared to rivals. Coming next: Alere plans to submit to the FDA by the end of 2013 an application to categorize the test as a CLIA-waived diagnostic, a move that will help make it broadly available in public health facilities and physician offices. CLIA-waiver-related studies are now underway.

Execs are also likely hoping that the diagnostic will quiet restive shareholders such as Coppersmith Capital Management. Earlier this summer, the outfit built up a bid to install its own board members and upend Alere's status quo. Alere rebuffed a pretty intense proxy fight but also pledged to double down on giving investors strong results.

Alere's results for the 2013 third quarter, released at the end of October, showed some progress. The Waltham, MA, company's net revenue nearly hit $754 million, up from $691.4 million over the same period in the 2013 third quarter. But net losses reached $24.8 million, versus a $9.2 million net loss over the same period last year. The company's revenue grew due to a number of recent acquisitions, but Alere also faced far higher costs, a trend that carried on from previous quarters.

Regardless, the company's new HIV test reaches a potentially large, untapped market. According to CDC statistics cited by the company, more than 1.2 million Americans have HIV, of which 207,000 haven't yet been diagnosed.

- read the release
- see the recap of Alere's Q3 financials

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