FDA clearance

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 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.