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.
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.
The new test will also be packaged as a kit for routine diagnosis of HDV RNA and HBV DNA.
A New Zealand minister says the country's genetic modification laws need to be re-examined to help combat climate change, the New Zealand Herald reports.
A new analysis finds some cancers receive more nonprofit dollars than others.
An Australian mother's conviction in the deaths of her children may be re-examined after finding that two of the children carried a cardiac arrhythmia-linked gene variant.
In Science this week: comparative analysis of sex differences in mammal gene expression, and more.