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 life sciences company can now offer its genetic tests in all 50 states in the US, as well as Canada and several other countries.
The Beckman Coulter unit provides genomic sequencing solutions to healthcare businesses, governments, and academia around the world.
The unscientific FDA report cites examples of harm that wouldn't have been avoided by its oversight or could have been better managed under CLIA, AMP said.
Maverix Biomics and Diagnomics have received CLIA validation for their pre-natal molecular diagnostic on a next-generation sequencing platform.
The test is the first of several planned CLIA-waived assays from Cepheid, and the first point-of-care test on the market to differentiate flu from RSV.
Pacific Biosciences announced this week that it has reached the final developmental milestone of its commercialization and licensing agreement with Roche.
At AMP's annual meeting, a researcher presented results of a study to determine the Cobas Liat Influenza A/B assay's impact on clinical decision making in the ER.
The company plans to establish a clinical laboratory to offer its Gensignia miRNA Signature Classifier for Lung Cancer Test, as well as other tests in the future.
The test detects and differentiates influenza A and B in about 20 minutes. It is the second CLIA-waived test on Roche's Cobas Liat platform.
According to Gizmodo, researchers have developed a list of a million nucleic acid-like polymers that could store genetic information.
An opinion piece in the Washington Post argues that golden rice could save the sight and lives of many children.
US National Institutes of Health has issued a new draft data-sharing policy, ScienceInsider reports.
In Cell this week: analysis of immune microenvironment in hepatocellular carcinoma, proteogenomic analysis of clear cell renal cell carcinoma, and more.