Hologic: FDA OKs Expanded Emergency Use Of Zika Virus Test

Diagnostic systems manufacturer Hologic, Inc. (NASDAQ:HOLX) recently received extended emergency use authorization (EUA) from the U.S. FDA for its Aptima Zika virus assay to be used with urine samples. These samples are collected along with patient-matched serum or plasma specimens.

Earlier in June, the FDA had authorized this test the first time for emergency use with serum and blood samples. However, the use with urine samples, as per the latest extended approval, provides more comprehensive and accurate diagnosis of Zika virus infection. Not only this, to perform the test successfully, urine samples can be collected any time from seven to 14 days following symptoms, as recommended by the U.S. Centers for Disease Control and Prevention (CDC).

According to the WHO, the Zika virus disease is caused by a mosquito-borne virus which may lead to severe neurological complications. People infected with Zika may have symptoms such as mild fever, rash, muscle and joint pains or conjunctivitis. It was predominantly a tropical disease discovered in 1947. However, recently, a large number of such cases have been confirmed in the continental U.S.

The Aptima Zika virus assay by Hologic is a molecular diagnostic tool for comprehensive detection of Zika virus RNA (Ribonucleic acid) in human specimens. RNA is a type of molecule which has substantial genetic information. The assay or trial runs on Hologic’s Panther System which is a market leading integrated platform that entirely automates all aspects of nucleic acid amplification testing. This platform reduces time, labor and energy for manual errors. The Aptima Zika Virus assay has not received any FDA approval for commercial use. It has only been authorized for Zika virus detection in in-vitro diagnostic tests. The assay is available for use in 50 states, Puerto Rico and U.S. territories.

Zika virus disease is believed to have taken a pandemic form, quite similar to AIDS. Governments and research organizations around the globe are finding ways, measures and technologies to check the spread of this deadly virus. As per Market Research Media report, the global Zika virus preparedness market is expected to reach $4 billion by 2022 and grow at CAGR 11% in the period 2017--2022.

Hologic’s management feels that FDA’s action is highly favorable for the company to tap into this growing market. Since no other FDA approved tests are currently available in the market to detect the virus, this aforementioned authorization will definitely boost this company’s share in the billion-dollar molecular diagnostic market.

We note that, Hologic is always in constant urge to provide solutions for meeting critical health care needs. We also believe that with the suspension of Medical Device Excise Tax, Hologic can now undertake various research related investments and increase the capability of the Zika virus assay.

Zacks Rank & Key Picks

Hologic currently has a Zacks Rank #3 (Hold). Better-ranked stocks in the medical product sector are GW Pharmaceuticals plc (NASDAQ:GWPH) , NuVasive, Inc. (NASDAQ:NUVA) and Quidel Corp. (NASDAQ:QDEL) . All these stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

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