Bioanalysis Zone

Imminent launch of urine-based HPV Carrier and oncogene mutation screening tests by Trovagene


Trovagene have recently announced that their urine-based HPV Carrier and oncogene mutation tests are expected to achieve analytical and clinical validation in March 2013.

Trovagene, Inc. (CA, USA) have announced good progression in the development of their proprietary, urine-based HPV carrier and oncogene mutation screening test and, once validation is successfully completed in March 2013, this will be available to clinicians to use with their patients. It will comprise tests for a specific p53 mutation as well as a specific double mutation in the hepatitis B virus. These mutations are highly associated with hepatocellular carcinoma, one of the most common causes of cancer mortality worldwide.

Trovagene has patented technology for detecting transrenal DNA and RNA in the urine, and expects to develop these technologies to enable the detection of oncogene mutations. The use of urine samples reduces the need for invasive procedures such as biopsies, and is not limited by volume as with blood samples.

Alongside validation studies, two clinical trials in India and one in Brazil are also currently underway. Another trial, with MD Anderson (TX, USA) is focussing on mutations in patients with advanced or metastatic cancers. It is predicted that KRAS oncogene tests will be introduced between April and June 2013, and the BRAF oncogene tests between July and September 2013. Further studies are being prepared to evaluate the detection of PIK3CA oncogene mutations.

Source: Trovagene announces commercial launch timelines for HPV carrier and oncogene mutation tests.



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