Hologic: FDA Okays Procleix Zika Virus Test Under IND Study

It’s raining opportunities for Hologic, Inc. (NASDAQ:HOLX) in the billion-dollar molecular diagnostics market. Soon after receiving an emergency authorization from the FDA for the use of its Aptima Zika Virus test, the company got FDA approval for its Procleix Zika virus blood screening assay.

Notably, this diagnostic test was approved under FDA’s Investigational New Drug (IND) study protocol to detect the presence of Zika virus in donated blood.

The Procleix assay, developed as part of Hologic’s long-standing partnership with Grifols and manufactured by the former, was originally used to screen donated blood for HIV, hepatitis B and C, West Nile and a handful of other viruses.

The Procleix Zika virus assay is an advanced version of this test, which now includes Zika virus as the criteria to be screened. As per terms of the IND study, the blood to be screened will be particularly collected from potential endemic areas in southern U.S., and may expand to other areas in the U.S. if the virus spreads.

Notable U.S. blood centers will run this test on Grifols’ Procleix Panther– a fully integrated and automated nucleic acid technology (NAT) system – for blood and plasma screening.

Although discovered in 1947, the public was alerted about the first confirmed Zika virus infection case in Brazil by the Pan American Health Organization (PAHO) in May 2015. On Feb 1, 2016, the World Health Organization (WHO) declared Zika virus a Public Health Emergency of International Concern (PHEIC).

So far, this virus has been predominantly affecting tropical countries. However, as of Jun 8, 2016, more than 691 confirmed cases of Zika have been reported in the continental U.S.

With the Centers for Disease Control and prevention (CDC) suspecting a Zika outbreak in new areas, the availability of the Procleix Zika virus blood screening assay, is expected to enhance Hologic’s shares in the molecular diagnostics market; which is projected to reach $9 billion by 2020.

Further, management believes that this approval reflects Hologic’s capability to quickly develop molecular diagnostics in response to new and emerging pathogens.

Interestingly, Hologic's competitor in the blood screening market, Roche, received IND for a Zika assay for blood screening in Mar 2016, indicating the gradual emergence of Zika virus tests in the molecular diagnostics space.

Hologic currently carries a Zacks Rank #3 (Hold). Better-ranked medical stocks are Baxter International Inc. (NYSE:BAX) , ICU Medical, Inc. (NASDAQ:ICUI) and LeMaitre Vascular, Inc. (NASDAQ:LMAT) . While Baxter holds a Zacks Rank #1 (Strong Buy), ICU Medical and LeMaitre carry a Zacks Rank #2 (Buy).