Close Menu

FDA clearance

The firm said that molecular product sales were up 103 percent, driven by the launch of the Solana Group A Strep assay earlier this year.

The FDA has approved Merck's Keytruda as a first-line treatment for non-small cell lung cancer in patients with high PD-L1 expression. 

The test enables donor screening laboratories to use PCR-based diagnostic technology to screen donated blood and plasma.

The test uses the helicase-dependent amplification technology that underpins Quidel's AmpliVue line of molecular assays.

The firm's multi-analyte quality controls for nucleic acid tests are designed to help large and small labs mitigate quality challenges. 

The PCR-based assays run on the company's Aries system, which itself received FDA clearance in October 2015.

The M1, a lower-throughput version of the company's Aries System, can process up to six samples and six assays at a time.

It is the first FDA-approved test for the stem cell transplant use case and meets the WHO International Standard for comparable results.

The software connects Luminex's FDA-cleared Aries PCR-based platform with its multiplex xMap technology-based Magpix system.

With this clearance, the respiratory pathogen panel is ready to enter the market to aid in accurate patient diagnosis for respiratory illness. 

Pages

In a cartoon, Vox explores the lack of women among this year's winners of the Nobel Prize.

Science reports a new US defense bill would establish two groups aimed at combating foreign influence on research. 

Nature Biotechnology discusses promising early results from two clinical trials of CRISPR-based therapy for β-thalassemia and sickle cell disease.

In Cell this week: analysis of tissue clones, metagenomic studies of ocean water samples, and more.