Roche gets FDA approval for cytomegalovirus diagnostic

Roche ($RHHBY) has snagged its second FDA approval of a diagnostic test this week, this time for a viral infection often found in organ transplant recipients. The agency moved to approve Roche's viral load test for cytomegalovirus (CMV), which uses the company's Cobas AmpliPrep system.

CMV is a potentially deadly disease often transmitted to patients alongside new organs, and Roche's test is a real-time polymerase chain reaction-based assay that the company says will help doctors identify and treat the virus before it has the chance to harm patients.

"With this test, laboratories now have an FDA-approved option for standardized and automated CMV viral load testing that improves the laboratory's workflow." said Paul Brown, head of Roche Molecular Diagnostics, in a statement. "It provides physicians with clinically useful information to aid in the management of solid organ transplant patients with CMV disease."

Roche plans to start shipping the test kit to labs in August.

Earlier this week, the FDA signed off on Roche's new dual-target test for HIV-1, using the Cobas TaqMan platform. All this comes as the Swiss firm has doubled down on its Dx business, announcing last month that it will invest $300 million in its Indiana diagnostics headquarters, planning to add 100 jobs in the process.

- read the Roche release

Suggested Articles

AI-based drug molecule designer XtalPi has secured a mammoth funding round totaling $318.8 million, from global banking and tech investors.

LabCorp has licensed a blood test from Genfit designed to identify patients with risky cases of the liver disease NASH.

Philips has launched a compact, single-use device for physically clearing potentially dangerous blood clots lodged in the arms and legs.