Roche's COBAS HIV blood test cleared in Italy:
This article was originally published in Clinica
Roche Diagnostics has gained clearance to sell its COBAS AmpliScreen HIV-1 v1.5 blood test for screening HIV in Italy. The PCR-based diagnostic assay is capable of revealing very early infections that cannot be detected by currently available antibody/antigen serological assays, said the Basel, Switzerland firm. Additionally, Roche Diagnostics now has PCR-based tests approved in Australia, France, Germany and Switzerland and Italy for detecting HIV and also HCV.
You may also be interested in...
Data show Opdivo/Cabometyx combo bests Sutent for overall and progression-free survival and response endpoints in first-line RCC. Exelixis CEO says comparison to Sutent is standard control and allows better comparison to other combo regimens.
ES: Public Company Edition: Fifty biopharma companies launched initial public offerings in the US last year and there have been 52 so far in 2020, including Metacrine, Dyne, Athira and COMPASS.
In an update to stakeholders, the US FDA says regulators can successfully evaluate a firm’s performance, allowing it to eventually get medical software to market in the agency’s Pre-Cert Program.