CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
June 8, 2018—Roche will feature at ASM Microbe 2018, in Atlanta, new test options that aim to expand the opportunities for laboratories to automate molecular testing. The company is introducing its CT/NG test for its Cobas 6800 and 8800 systems. The test, which was cleared by the FDA in April, allows laboratories to consolidate STI testing with Roche’s viral load test menu—including HIV, hepatitis B, hepatitis C, and cytomegalovirus—as moderate-complexity tests. Roche has TV/MG (Trichomonas vaginalis and Mycoplasma genitalium), HPV, and HIV1/HIV2 qualitative assays in development for the same platforms (not available for sale in the U.S.).
Also being introduced for the Cobas 6800/8800 platforms is the Cobas Omni Utility Channel, which enables labs to consolidate laboratory-developed tests with in vitro diagnostic tests on the same system. This feature aims to help labs to minimize errors and free up staff by fully automating the manual steps for routine LDTs.
Roche is also highlighting the addition of its recently cleared Cobas Factor II and Factor V test to the menu for its Cobas 4800 system. “The test enables laboratories to simultaneously assess Factor II and Factor V gene mutations from a single patient sample, which can reduce hands-on time when testing patients for inherited thrombophilia,” the company said in a release. The addition of the test allows labs to consolidate genomics, oncology, and microbiology testing onto a single platform.