FDA clearance

Physicians can now use the Dako PD-L1 IHC 22C3 pharmDx assay to identify urothelial carcinoma patients who may benefit from the anti-PD1 immunotherapy.

The FDA granted the assay's status based on its ability to detect both ovarian and pancreatic cancer in asymptomatic individuals over the age of 65.

Clinical research has shown that the assay exhibited 100 percent sensitivity compared to culture-based testing methods, Hologic said.

The Cobas HPV Test is now approved for use as a primary screening test with BD's SurePath and Hologic's ThinPrep PreservCyt Solution.

The test, which uses automated reverse-transcription real-time PCR, expands the firm's menu of CLIA-waived tests for use in near-patient and point-of-care settings.

The system is for high-throughput testing in central labs and the firm plans additional assays for infectious and sexually transmitted diseases.

The new assay simultaneously detects four viral targets in donated blood plasma in a single sample and can add value to the biologics development space.

With the new clearance, DiaSorin's test can be run on genital swabs, and all cutaneous and mucocutaneous swab samples, as well as CSF samples.

Physicians can now use the Dako PD-L1 IHC 22C3 pharmDx assay to identify cervical cancer patients who may benefit from the anti-PD1 immunotherapy.

The test is Micronics’ first to receive FDA clearance, and the company is pursuing CE marking for it and the PanNAT system.