Roche launches rapid HIV, hep C tests in Europe

Roche ($RHHBY) is rolling out rapid tests for HIV, hepatitis C and hep C genotyping in Europe, continuing its molecular diagnostics winning streak a couple of weeks after scoring FDA approval for related tests and unveiling promising numbers for its testing business.

The Basel-based company's cobas HIV-1, HCV and HCV Genotyping (GT) tests can run simultaneously on Roche's cobas 4800 system, speeding up processing times while streamlining workflow, the company said in a statement. Roche's HIV-1 uses dual-target technology to pinpoint two regions of the HIV-1 genome, allowing technicians to determine the amount of harmful RNA in a patient's blood.

Roche's Cobas HCV and HCV Genotyping tests rely on different screening methods, with cobas HCV using a dual-probe to screen for hep C virus RNA and for how a patient responds to treatment with antiviral drugs. Cobas HCV Genotyping uses PCR to identify 6 HCV genotypes from human plasma or serum of patients who have the infection.

The tests respond to a critical need. There were about 35 million people living with HIV globally in 2012, according to the World Health Organization's (WHO) estimates cited by Roche. Sound diagnosis, along with treatment, could boost life expectancy for patients infected with the virus, the company said in a statement.

Roland Diggelmann, COO of Roche Diagnostics Global--Courtesy of Roche

Hepatitis C afflicts about 200 million individuals across the globe, with most people not knowing they're infected, according to the WHO's data. Roche's tests could catch the disease early before complications such as liver failure and cirrhosis set in.

"With the addition of these assays to the cobas 4800 menu, more laboratories have access to advanced virology assays that provide reliable results for confident patient management," Roland Diggelmann, COO of Roche Diagnostics, said in a statement.

Next up, Roche plans to launch its cobas HBV test for hepatitis B detection, rounding out its portfolio of viral load monitoring and genotyping tests that run on its cobas 4800 system, the company said in a statement.

As it stands, Roche seems to be doing well for itself in the diagnostics world. The company recently revealed positive numbers for its diagnostics division, with sales climbing 6% to 7.8 billion Swiss francs ($8 billion) for the first 9 months of 2015. Although Roche's tissue diagnostics business largely contributed to that haul with a 12% jump in sales, the company's diagnostics division "shows very good momentum overall," Diggelmann said during the company's earnings call, auguring bigger things to come.

Roche also recently scored FDA approval for two of its viral load tests for patients with hep C or hep C. The company is still waiting for the agency's blessing for its tests for HIV-1 and cytomegalovirus, which will complete its viral testing portfolio once they're approved.

- here's Roche's statement

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