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FDA Clears Single-Use PCR Test That Rapidly Detects STIs in Women

The FDA has cleared the Visby Medical Sexual Health Test, a PCR diagnostic test for the detection of sexually transmitted infections in women.

Gary schoolnikVisby medical sexual health testVisby medical sexual healthDrug administrationVisby medical sexual health instructions forProfessor of medicine at stanford universityVisby medicalVisby medical vaginal specimen collectionChief medical officerLancet infectiousMedical sexual health point of care instructions

Visby Medical™ Receives FDA Clearance and CLIA Waiver for Second Generation Sexual Health Test for Women

/PRNewswire/ Visby Medical™ announced today that it has received 510(k) clearance and was granted a CLIA waiver from the U.S. Food and Drug Administration.

United statesLamont tylerDenise sweeneyMark medlenGary schoolnikCenters for diseaseVisby medical sexual health testSexual healthVisby medical sexual healthDrug administrationVisby sexual health testSexual health testProfessor of medicine at stanford universityMedical sexual healthVisby medical senior vice presidentDisease control

Sherlock Biosciences Expects Sense Biodetection Buy to Accelerate Commercialization Plans

The firm now anticipates accelerating its commercialization phase by one to two years and will mix and match its technologies going forward.

United kingdomUnited statesJohn bishopBrian dechairoDavid wallHarry lambleMike rubenSanta barbaraSherlock biosciencesHeiner dreismannJohns hopkinsUniversity of californiaInnova medical groupLucira healthCue healthTulane university

Sapphiros Taps Teresa Abraham for VP of Scientific and Technical Affairs

Sapphiros Taps Teresa Abraham for VP of Scientific and Technical Affairs
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United statesNamal nawanaTeresa abrahamAmerican association for the advancement of scienceScientific affairsUs department of healthHuman servicesTechnical affairsTechnology policy fellowshipVice presidentMed techTechnical partnershipsVisby medicalSan joseSilicon valleyAmerican association

COVID-19 Still a Focus for Infectious Disease Test Developers in 2022, but Ceded Some Ground

Tests for other respiratory viruses, as well as sexually transmitted infections and tuberculosis, moved back into the development pipeline last year.

United statesSiemens healthineersTulane universityMelinda gates foundationThermo fisherCue healthUs department of healthLucira healthLaboratory corporation of americaOrasure technologiesHuman servicesBecton dickinsonUs centers for diseaseDrug administrationWorld health organizationLiverpool school of tropical medicine