BD and Roche Secure FDA Approval for HPV Self-Collection Solutions

Source: 360Dx, IVD Toolman

Roche and BD Announce FDA Approval of Their Respective Self-Collection Solutions for HPV

Roche's Self-Sampling Device

This solution allows women to collect their own vaginal samples in a healthcare setting and then send them to a laboratory for analysis using Roche's Cobas molecular system. The solution has been approved for use with Roche's FDA-approved Cobas HPV test, which runs on the Roche Cobas 4800, 5800, and 6800/8800 systems. The company noted in a statement that Roche's solution is designed to provide an alternative to clinicians' collection procedures while "delivering accurate and reliable results."

"Eliminating cervical cancer by 2030, as per the [World Health Organization]’s goal, is within reach through vaccination, innovative diagnostic tools, and screening programs," said Matt Sause, CEO of Roche Diagnostics, in a statement. "Our HPV self-collection solution supports this goal by reducing barriers and providing access to HPV screening, allowing individuals to privately collect their own samples for HPV testing."

The company stated that Roche, in collaboration with the U.S. National Cancer Institute, launched the "Last Mile" initiative for cervical cancer, which, to a certain extent, facilitated the regulatory pathway to approval.

BD's Self-Sampling Device

BD Announces FDA Approval for Self-Collection of Vaginal Samples for Human Papillomavirus (HPV) Testing When Cervical Specimens Are Not Accessible by Other Means

HPV is the cause of almost all cervical cancers, and HPV testing is the preferred screening method recommended by the American Cancer Society. The BD Onclarity™ HPV Assay has received FDA approval for use as a primary HPV test without the need for a speculum during traditional Pap smear procedures. The new approval for self-collected samples opens the door to less invasive testing options and improves access to cervical cancer screening for individuals facing barriers.