Hologic: FDA OKs Expanded Emergency Use Of Zika Virus Test
Zacks Investment Research | Sep 13, 2016 06:48AM ET
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.
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