Inflammatix hopes to market an 18-gene panel that will be able to tell from a blood sample whether a hospitalized patient has a bacterial, viral, or no infection.
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.
The real-time PCR-based test runs on the BD Max system and comes in a single tube that snaps into the BD MAX extraction cartridge.
The Taiwanese research team that developed the method showed in a new study that it could better detect BRAF mutations than conventional PCR plus Sanger sequencing.
The firm sees the new panel as an important step forward in its strategy to further penetrate the molecular diagnostics market with its qPCR products.