real-time PCR

The FDA approved the real-time PCR-based test for use on the Cobas 6800 and 8800 systems to assess the response of transplant patients to treatments. 

The GenePOC GBS LB assay uses real-time PCR technology to detect GBS colonization from lim broth samples with sensitivity of 95.9 percent and specificity of 95.5 percent. 

The deal covers Streck's cell stabilization and molecular products, including the soon-to-be released Zulu RT, a rapid real-time PCR instrument. 

The Alabama-based firm has grown its infectious disease testing menu for the BD Max system to six CE-marked tests identifying bacteria, viruses, or fungi.

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 test for cervical cancer screening previously received the IVD mark and US Food and Drug Administration approval on the Cobas 4800 system.

The assay has been available outside the US since November and runs on the Liaison MDX benchtop instrument. 

The firm said that it is on track to seek FDA approval for a liquid cytology solution early this year.

The firm said that it has completed clinical trials for the Group B Strep assay for the FDA and will start trials for the C. difficile test this month.