TruScreen, a New Zealand cancer screening technology company, 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 believes 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,” Dillon says.
“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.”
At present, Mexico has a population of over 120 million and with 30 million women of screening age the potential Mexican market for cervical cancer screening is estimated at NZ$100 million per annum, Dillon estimates.
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 percent compared to 31 percent for the pap smear,” Dillon adds.
TruScreen currently has distribution contracts in 11 international markets, including China, Latin America, Central Asia, Russia, the Middle East and Eastern Europe.