The company,Trovagene, based in San Diego, Calif., announced in mid-January that it has entered into contracts to distribute its Trovera tests with a number of partners in Europe and the Middle East. Including Bulgaria, where the contract partner is NM Genomix.
These partners will present the advances of the test in front of doctors, geneticists and oncology units from the region, and will also allow early access to the new tests developed by Trovagene with Boreal Genomics, expected to be presented in the summer of 2017.
The Trovera tests currently offered by the company provide information on the mutation status of several genes (EGFR, KRAS and BRAF), for which target therapies for lung and colorectal cancer and melanoma have been developed and are approved (including in Bulgaria). The analysis is based on the so-called “liquid biopsies” that aim to overcome the limitations of traditionally used tissue biopsies.
One of the main challenges to in companion diagnosis for personalized therapies is the lack of tumor material needed for genetic analysis. Statistics show that up to 25% of tissue biopsies do not have enough tumor cells. Moreover, due to the difficult condition of the patients and the complexity of the procedure, no tissue can be taken for examination. Another problem is that tissue biopsies has cells from a very limited section of the tumor, which itself an extremely heterogeneous cell population. Thus, the mutation profile determined by them does not always reflect the actual frequency of the mutations.
The “liquid biopsy” used in Trovagene tests may be blood or urine, making it a much more accessible and non-invasive method for collecting tumor DNA. Combining both sources (blood and urine) increases sensitivity and reduces the chance of false negative results. The noninvasiveness of the method allows the test to be performed more than once and is used not only for primary tumor status determination but also for its dynamic tracking over time.