Recent Device Approvals: cobas® HCV Test

The FDA has recently approved the cobas® HCV Test to be marketed. The cobas® HCV is a laboratory test used to measure the amount of hepatitis C virus (HCV) RNA (ribonucleic acid) in a patient’s blood. Viral RNA is genetic material from HCV.

Hepatitis C is a liver infection caused by HCV. Hepatitis C is transmitted when blood or another body fluid from a person infected with the Hepatitis C virus enters the body of someone who is not infected. This can happen through sharing needles, syringes, or other drug-injection equipment, from mother to baby at birth, and less commonly, through sexual contact. Approximately 75% - 85% of people who become infected with hepatitis C develop chronic infection. Chronic Hepatitis C can lead to serious health issues, like cirrhosis or liver cancer.

The results from the cobas® HCV must be interpreted within the context of all other relevant clinical and laboratory findings.