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.
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.
NPR reports that many USDA researchers working at the two agencies that are relocating to the Kansas City area are declining to go.
Genetic genealogy has helped exonerate a man who has been jailed for 20 years, Agence France Presse reports.
A new report says genetically modified food might be necessary to be able to feed a planet of nearly 10 billion people, Bloomberg says.
In Nature this week: new RNA editing approach called LEAPER, draft assembly of Musa balbisiana banana genome, and more.