The test is intended for use by blood collection facilities and is not approved for the individual diagnosis of Zika infection.
Companies are now expected to have their tests cleared by authorities for clinical use, and to bring their entire catalogs into line with the new regulations by May 2022.
The firm's in vitro diagnostic nucleic acid screening test performs direct detection of Babesia DNA and RNA in whole blood specimens from human blood donors.
The group is proposing women ages 30 to 65 be screened with cervical cytology every three years or receive testing for high-risk HPV every five years.
The company shared validation data this week that it said led the FDA to approve use of the test in a new prospective trial of Roche's Tecentriq in NSCLC.
Until March 2018, when the patent in question expires, Cenata will have its Harmony test performed by Medirex in Slovakia.
The firm said that immunoassays had 19 years in a row of double-digit growth, driven in part by an automated workflow approach to achieving lab efficiencies.
The CE-marked test enables health professionals to distinguish between HIV-1 and HIV-2, and runs on the fully automated Cobas 6800/8800 systems.
The test, which simultaneously detects MRSA and Staphylococcus aureus, is designed to run on the company's Liat PCR point-of-care platform.
Enzo's patent relates to modified nucleotides for diagnostic and therapeutic applications, and is central to separate ongoing lawsuits with diagnostic developers.
The Washington Post reports on a Federal Bureau of Investigation plan to place rapid DNA analyzers at booking stations around the country.
In an editorial, officials from scientific societies in the US and China call for the international community to develop criteria and standards for human germline editing.
The US National Institutes of Health is to review studies that have received private support for conflicts of interest, according to the New York Times.
In Science this week: the PsychENCODE Consortium reports on the molecular mechanisms of neuropsychiatric disorders, and more.