Oncor
This article was originally published in The Gray Sheet
Executive Summary
Submits premarket approval application Oct. 3 for the in vitro diagnostic use of its chronic myelogenous leukemia (CML) Mbcr/abl genetic test system. The company says that in multi-center trials involving close to 350 patients, the Oncor test, when used alone, "was 96.1% sensitive and 99.3% specific in detecting CML, compared to the detection rates of a combination of the best presently available methods." The Gaithersburg, Maryland-based firm estimates that its test will cost "five times less than conventional methods"
You may also be interested in...
Alvotech Highlights Lack Of Simponi Rivals As It Delivers Golimumab Results
Alvotech has just become the first company to announce positive topline results from a confirmatory clinical study for a proposed golimumab rival to Simponi and Simponi Aria – and moreover, the firm sees limited competition from other biosimilars on the horizon.
Xbrane Assembles The Troops As FDA Says No To Lucentis Biosimilar
Xbrane Biopharma was riding the crest of a wave with the EU launch of its biosimilar to Lucentis, following years of toil and investment. However, plans to roll out the product in the US will have to be pushed back – likely – into the middle of 2025, following a US FDA complete response letter.
UK MHRA Updates Assistive Tech And Borderline Regulations
Device classification themes were uppermost in April for the UK regulator, which issued key guidance in two areas prone to complexities. It also contributed to the MedTech Directorate’s one-year progress report.