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 China-based company said that it now has 11 products that have been CE marked, and has applied for additional CE certification for other tests.
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 new European initiative promises to deliver multiple new tests and methods for improving the treatment of breast cancer and rectal cancer.
The company believes its product, called Constellation, will differentiate itself from current commercial offerings in terms of throughput and multiplexing capability.
Investigators using droplet digital PCR methods are following cell-free tumor DNA in the blood, looking for patterns coinciding with immunotherapy treatment outcomes.
The firm recently released two droplet digital PCR-based assays that can characterize edits generated by CRISPR-Cas9 or other genome editing tools.
Researchers combined a microfluidic technology called the CTC-iChip with digital PCR to potentially improve cancer detection in hepatocellular carcinoma patients.
University of Cambridge researchers found that the portion of tumor DNA in patients' blood could predict treatment response and time to disease progression.
Esoterix sued Myriad in September, claiming that its myRisk Hereditary Cancer panel and services directly infringe four patents it has exclusively licensed.
Consulting company McKinsey says diagnostics companies will have to combine genomic data analysis, electronic medical records, effective reimbursement strategies, and regulatory compliance in order to win.
A new report has found that researchers in Africa are still heavily dependent on funding from organizations in the US, Europe, and China, Nature News says.
An article in The Atlantic argues that the progress being made in science isn't keeping pace with the money and time being spent on research.
In Science this week: a CRISPR screen identifies sideroflexin 1 as a requisite component of one-carbon metabolism, and more.