Roche gets FDA OK for new HIV diagnostic

Roche's ($RHHBY) diagnostics unit scored FDA approval for another viral load HIV test, and the company is looking to get the kit on the market later this year.

The COBAS TaqMan HIV-1 test expands on the company's existing assays, focusing on two regions of the HIV-1 genome and dodging regions that are current drug targets, allowing for increased reliability in the case of mutation, the company said. Roche launched its first dual-target HIV diagnostic back in 2008, and its tests have been administered more than 8 million times since, according to the company.

Getting this latest test onto the market is the next step in Roche Diagnostics' expansion, Paul Brown, head of the unit, said in a statement. "Roche is committed to developing new diagnostic tools such as this highly innovative HIV 'dual target' test to help improve the ability of physicians to monitor viral load and properly treat people living with HIV," he said.

The FDA nod serves as something of a validation of Roche's recent focus on expanding its diagnostics business. Last month, the company announced it would invest $300 million in its Indiana Dx headquarters, planning to add 100 jobs in the process.

- read Roche's statement

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