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Labs in China can now use the Cobas EGFR Mutation Test v2 with either tissue or plasma samples as a CDx for three Roche oncology drugs in NSCLC patients.
The program started in 2014, originally to increase access to HIV diagnostics, and provides special pricing to qualifying organizations in eligible countries.
Included in the 510(k) clearances was one for AMS Diagnostics' Liasys 600 Electrolyte Measurement System for measuring sodium, chloride, and potassium in human serum.
With two FDA-cleared platforms available, the technology is drawing clinicians interested in reaping its near-term benefits while preparing for its future impact.
Regulators in the country granted additional approval of the test as a companion diagnostic for Rozlytrek, marketed in Japan by Roche's Chugai Pharmaceutical.
The closure has no impact on the firm's other Los Gatos location, the original home of GeneWeave Biosciences, which Roche acquired in 2015 for up to $425 million.
A combination of three biomarkers accurately predicted abnormal accumulation of beta-amyloid plaques in the brains of living Alzheimer's disease patients.
The company's patent related to labeled nucleotides for use as diagnostic tools and as therapeutic agents has been invalidated.
According to the company, it has shipped more than 1,700 of the IVD analyzer platforms since launching sales globally in 2017.
A UK court determined that Ariosa's licensee infringed upon at least one claim of Illumina's European patent 1 524 321 and upheld the patent's validity.