Close Menu

real-time PCR

LabCorp's test is being made available pursuant to FDA guidance that allows high-complexity, CLIA-certified labs to perform their own tests for SARS-CoV-2.

Some believe that more could be done to help deliver diagnostics to the European market. 

 

 

A*STAR and Tan Tock Seng Hospital developed the test, which is the first diagnostic to be deployed in the country's hospitals since the outbreak began in December.

The company said its Liberty16 device is capable of detecting viral infection quickly, and can be deployed where other PCR instruments are too big to go.

The single-tube real-time PCR-based test has also received CE marking, according to Seegene, and is now commercially available.

The Centers for Disease Control and Prevention says one of the test reagents will likely need to be remanufactured in its labs.

The EUA allows the test to be used at all CDC-qualified labs in the US on patients who meet CDC criteria for testing for the coronavirus.

Qiagen obtained CE marking for its Therascreen PIK3CA RGQ PCR kit to aid in identifying breast cancer patients with a PIK3CA mutation.

The companies will develop tissue-based companion diagnostics for Amgen's investigational treatment AMG 510 for non-small cell lung cancer.

The seven-year grant renews funding for the Antibacterial Resistance Leadership Group, led by Duke University and UCSF, with $15 million in 2020.

Pages