NEW YORK – Roche announced Wednesday that its self-collection solution for human papillomavirus has received approval from the US Food and Drug Administration.
The solution allows women to collect their own vaginal samples in a healthcare setting that are then sent to a laboratory for analysis with Roche's Cobas molecular system. The solution is approved for use with Roche's FDA-approved Cobas HPV test, which runs on the Roche Cobas 4800, 5800, and 6800/8800 systems. Roche's solution is intended to offer an alternative to clinician collection procedures while "providing accurate and reliable results," the company noted in a statement.
"With vaccinations, innovative diagnostic tools, and screening programs, achieving the [World Health Organization's] goal of eliminating cervical cancer by 2030 is within reach," Roche Diagnostics CEO Matt Sause said in a statement. "Our HPV self-collection solution helps support this goal by reducing barriers and providing access to HPV screening by allowing people to privately collect their own sample for HPV testing."
Roche collaborated with the National Cancer Institute on its Cervical Cancer "Last Mile" Initiative, and the partnership partially facilitated the regulatory pathway toward the approval, the company said.