The real-time PCR, sample-to-answer assay provides surveillance of whooping cough, a contagious respiratory disease, in clinically symptomatic patients.
The Ventana PD-L1 assay was approved as a complementary diagnostic for bladder cancer patients being considered for treatment with the immunotherapy Imfinzi.
The test runs on Qiagen's Rotor-Gene Q MDx system and is designed to qualitatively detect the JAK2 V617F/G1849T allele in genomic DNA from whole blood.
The assay has been available outside the US since November and runs on the Liaison MDX benchtop instrument.
To develop the test, the firm said it used a library of MRSA strains collected around the world, and included components that reduce false positive results.
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.
NPR says the explosion and fire earlier this week at a Russian lab that stores dangerous pathogens revives the question of whether such samples should be kept.
According to Wired, Nebula Genomics is providing a way for people to get their genomes sequenced anonymously.
A 26-year-old woman tells Cosmopolitan about learning her APOE status at a young age.
In Science journals this week: a functional genomic screen uncovers drug combination that increases KRAS inhibitor efficacy in aggressive lung cancer, and more.