The test is the second infectious disease assay from Bioneer to be CE marked, and the South Korean company has a third test in the pipeline.
The company posted higher total sales for the first half of its fiscal year 2020 on sales growth in both in Japan and internationally.
The firms will codevelop companion diagnostics for anti-PD1/PD-L1 immunotherapy treatments for cancer.
The company has signed technology deals with Repertoire Genesis of Japan, Stratifyer Molecular Pathology of Germany, and the University of Bonn.
Promega's microsatellite instability technology will be used to develop an on-label, solid tumor companion diagnostic for pembrolizumab.
The company said three clinical centers have validated the test in a prospective clinical trial involving more than 10,000 participants.
Under the new 15-year exclusive agreement, the test will become available through all of Sonic's clinical labs and anatomic pathology practices in the US.
MGI Tech will market Pillar Biosciences' Onco/Reveal NGS panels alongside its high-throughput, automated library prep systems outside the US.
The approval allows the company to directly market and sell the CTC technology to labs and other institutions to develop and implement IVD tests.
The two companies have been working together since February and now are formalizing plans to develop and test new products.
