The certification enables the company to offer its flow cytometry-based myeloid-derived suppressor cell assay for cancer patients.
The point-of-care test detects and distinguishes influenza A and B as well as respiratory syncytial virus in about 20 minutes.
The certification enables the company's lab in Grenoble to receive patient specimens from the US for testing with its ImmuneTracker Dx cancer immunotherapy assay.
The molecular diagnostics arm of Patrick Soon-Shiong's healthcare empire performs sequencing and proteomic analysis for the GPS Cancer test.
Regulators have proposed banning Theranos CEO from owning or operating any lab for two years, the Wall Street Journal reports.
The firm aims to establish a CLIA-certified laboratory within the facility and provide whole-genome sequencing services for human, plant, and animal samples.
The state of California has given the lab permission to start offering its QClamp test to screen for tumor oncogenic driver and resistance mutations in tumor DNA.
It is also the first such lab in China to be licensed by the State of California, allowing it to process samples from the state.
Bill 1392 enumerates various requirements labs would have to follow to provide DTC genetic testing, but doesn't mandate FDA approval or clearance of tests.
The Centers for Medicare & Medicaid Services has sent a letter to Theranos that says some of its lab practices are deficient, and one poses "immediate jeopardy."
The Guardian reports that some UK physicians are calling for increased regulation of direct-to-consumer genetic tests.
US tax agency says 23andMe's genetic health test can be claimed as a medical expense for tax purposes, the Wall Street Journal reports.
Two Democratic lawmakers argue at USA Today that independent science is under attack by the Trump Administration.
In PLOS this week: networks of genes co-expressed in depression, role of minichromosome maintenance genes in lung adenocarcinoma, and more.