oncoReveal ® CDx is a NGS based IVD kit that uses Pillar's proprietary SLIMamp (Stem-Loop Inhibition-Mediated amplification) technology for detection of single nucleotide variants (SNVs), insertions ...
SAN DIEGO, May 19, 2020 /PRNewswire/ -- Invivoscribe to offer the LeukoStrat ® CDx FLT3 Mutation Assay as an FDA approved kit with analysis software. In 2017, Invivoscribe's LeukoStrat ® CDx FLT3 ...
More than seven years after it unsuccessfully attempted to acquire Illumina for $5.7 billion, Roche is now partnering with its erstwhile takeover target on a common goal: Advancing the use of ...
Alex Aravanis, MD, PhD, Illumina Chief Technology Officer and Senior Vice President Illumina has revealed plans to step up its cancer detection efforts by launching a new in vitro diagnostic (IVD) ...
Precision approaches to treating cancer are making companion diagnostics increasingly valuable in determining patient eligibility. Image credit: SewCreamStudio via Shutterstock.com. · Medical Device ...
Australia’s Therapeutic Goods Administration (TGA) issued a consultation paper on Tuesday to propose a new framework for the regulation of companion in vitro diagnostic (IVD) devices. The framework ...
EMA recognizes that a regulatory framework, under which medicines and diagnostics are developed and approved independently, may not be ideal. The European Union has been overhauling its rules on ...
The collaboration will begin with the development of a CDx-IVD for larotrectinib for the Chinese market. Larotrectinib is the world's first TRK inhibitor to be approved in patients with TRK gene ...