TruScreen Limited, a New Zealand company with a unique real time cervical cancer screening technology, has received certification from the Federal Commission for the Protection against Sanitary Risk (COFEPRIS) in Mexico.
Under this certification the company’s proprietary TruScreen cervical cancer screening device may be sold to government hospitals and public entities and be marketed and promoted to the general public in Mexico.
TruScreen’s CEO Martin Dillon said “the Mexican market is strategically significant for the company’s growth plans in the broader Latin American region. The granting of this COFEPRIS approval will enable us to sell to any government hospital or public health program in Mexico. This will be a significant validation of TruScreen in Latin America as a cervical cancer screening solution, and is central to TruScreen’s strategy to expand into other Central and South American markets.”
Mexico has a population of over 120million. With 30million women of screening age the potential Mexican market for cervical cancer screening is estimated at NZ$100 million per annum. Interim results from a clinical trial being conducted in Guadalajara, Mexico, report TruScreen performing significantly better than the traditional pap smear test in identifying pre-cancerous cervical abnormalities in Mexican women.
TruScreen’s sensitivity achieved in this trial is currently 78% compared to 31% for the pap smear.