Roche Diagnostics got the nod for its Elecsys Anti-HAV II test for the detection of total antibodies — IgG and IgM — to the hepatitis A virus.
A brief recap of Diagnostics news the week of Feb 15, 2019: SpeeDX, Translational Software, PWN Health & Allscripts Healthcare Solutions, Immunovia, Curculogene, Fujirebio Diagnostics, Precipio
Launched to commercialize technologies from two leading glycoproteomic researchers, the startup's lead test is a mass spec-based assay for triaging pelvic masses.
By testing for changes in PCT levels, clinicians can use the assay to assess the risk of a patient getting a lower respiratory tract infection and sepsis.
The partners will develop an amyloid β 42/40 ratio assay to identify patients who may benefit from treatment with Janssen's drug called atabecestat.
The three firms each had 510(k) clearances for multiple products from the FDA last month for marketing.
The companies will validate and commercialize the assay as a companion diagnostic to identify best responders to Morphotek's investigational ovarian cancer treatment.