Roche said at the AMP annual meeting that it plans to commercialize the system in Europe with CE IVD marking for clinical applications and in the US with a 510(k) exemption.
The approach could allow doctors to more accurately and more easily identify which patients are free from cancer after radiation treatment.
Investigators developed a droplet digital PCR assay targeting driver mutations and found that changes in circulating DNA were correlated with response to radiation.
The company is collecting validation evidence it intends to submit to the FDA next year, which will also support launch of the test as an LDT.
The company said Q2 sales increased 11 percent on a currency-neutral basis, driven by growth in both its Life Science and Clinical Diagnostics segments.
Bio-Rad tallied net sales of $551.5 million compared to $500.1 million in Q1 2017, driven by growth in both its Life Science and Clinical Diagnostics businesses.
The assay could provide detection of HBV infection at early stages, potentially preventing progression to cirrhosis or hepatocellular carcinoma.
Researchers have developed a PCR-based assay to gauge whether manatees are present in waters.
In PNAS this week: mouse model of genetically induced emphysema, gene expression signatures of circulating melanoma cells, and more.
The firm has provided glimpses into its strategies for developing a line of regulated droplet digital PCR tests in a number of recent forums.
The United Nations is to consider a ban on field testing gene drives at a meeting being held next week, Technology Review reports.
The Associated Press reports that gene-edited food may soon be for sale.
The US Department of Health and Human Services is beginning a series of meetings on human fetal tissue research, Stat News reports.
In Cell this week: epigenetic change linked to glioblastomas, rare and low-frequency variants contributing to multiple sclerosis risk, and more.