A Medical Device Daily

Roche Diagnostics (Pleasanton, California) reported that it has submitted its automated test for Hepatitis C viral load monitoring to the FDA for review.

The test, called the COBAS AmpliPrep/COBAS TaqMan HCV Test, is designed to provide information about the quantity of Hepatitis C virus in a patient’s blood, from very high to very low levels. This type of diagnostic, called viral load testing, is a key measure of how well a patient infected with Hepatitis C is responding to drug therapy, according to Roche.

Hepatitis C is an asymptomatic blood-borne infection of the liver, yet one that can cause serious chronic disease, liver failure, in some cases, death. Combination therapy with pegylated interferon and ribavirin drugs (currently the treatment of choice) can get rid of the virus in up to five out of 10 persons infected with genotype 1 of the Hepatitis C virus, and up to eight out of 10 persons infected with genotypes 2 and 3.

“This is an important milestone in the development of our automated virology portfolio for the U.S. market,” said Daniel O’Day, head of Roche molecular diagnostics, the business area of Roche Diagnostics that developed the test. “[O]ur goal is to continue to increase system integration and automation, enabling labs to deliver reliable healthcare information with greater ease and efficiency.”

Roche’s diagnostics division supplies testing products and services to researchers, physicians, patients, hospitals and laboratories.