publication date: Mar. 25, 2016

FDA Approves Roche Hepatits C RNA Test 


FDA approved a hepatitis C virus quantitative RNA test to be used as an aid in the diagnosis of HCV infection for certain patient populations.

Results from the COBAS AmpliPrep/COBAS TaqMan HCV Test v2.0, developed by Roche, can now be used to confirm an active hepatitis infection, in addition to providing an accurate measurement of how much virus is in a patient’s blood, to help a physician determine the best course of treatment.

The test is the first quantitative HCV RNA test to be approved for use as an aid in diagnosis for active HCV infection. This expanded indication is in addition to its approved use as a viral load test to help physicians assess a patient’s response to antiviral therapy. Roche HCV viral load tests have also been used to establish the treatment efficacy of direct-acting antiviral treatment regimens recently approved by the FDA.

The dual-probe PCR assay is intended for use in the management of patients with chronic HCV, in conjunction with clinical and laboratory markers of infection, and as an aid in diagnosis for individuals with antibody evidence of HCV infection with evidence of liver disease, individuals suspected to be actively infected with HCV antibody evidence, and individuals at risk for HCV infection with antibodies to HCV. Detection of HCV RNA indicates that the virus is replicating and therefore is evidence of active infection.

The test is an in vitro nucleic acid amplification test for the detection and quantitation of hepatitis C virus RNA genotypes 1 to 6 in human EDTA plasma or serum. It can be used to predict the probability of sustained virologic response early during a course of antiviral therapy and to assess viral response to antiviral treatment, as measured by changes of HCV RNA levels.


The University of Pennsylvania and Genisphere LLC formed a collaborative research agreement to study targeted nanotherapeutics. The collaboration between Genisphere, provider of the 3DNA drug delivery platform, and UPenn’s Theresa Busch, will utilize a breast cancer model to study photodynamic therapy.

Photosensitizing drugs are administered to patients prior to surgery, and then activated by visible light after the tumor tissue is removed, to destroy cancerous cells left behind. The delivery of PDT to the entire surgical field is essential, thus selective photosensitizer accumulation in diseased cells is necessary to avoid therapy-limiting damage to normal tissues.

“When used in the intraoperative setting, PDT provides for local treatment at the site of surgery and can be effective in eradicating undetected or unresectable tumor,” said Busch, a research associate professor of radiation oncology. “This concept is suggested by patient outcomes in our previous clinical trials of intraoperative PDT for malignant pleural mesothelioma, and we are currently conducting a randomized phase II clinical trial for this indication.

“This approach can be adapted for intraoperative PDT of breast cancer; however, the addition of a photosensitizer that is targeted to breast cancer cells could broaden the therapeutic window and selectively increase cytotoxic effect.”

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