The PCR-based test, run on Roche's Liat platform, was among several other assays that was cleared by the agency last month.
With only one test FDA-approved for primary hrHPV screening, groups express concern about feasibility of moving away from co-testing
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.
Their study suggests that commercial IHC assays for PD-L1 can yield compatible and transferrable results if handled appropriately.
Advantages like better accuracy and easier assay development could help HRAM systems carve out space in a market currently dominated by triple quadrupoles.
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.
Until March 2018, when the patent in question expires, Cenata will have its Harmony test performed by Medirex in Slovakia.