Roche Gets FDA Approval for the HPV Self-Test in the US

Roche, one of the first companies to provide an HPV self-collection option in the US, recently announced its FDA approval. Cervical cancer can be detected and treated early before it has a chance to grow by using HPV screening to identify women who are at risk of the illness.

Self-collection of HPV provides a convenient screening method. In a medical facility, a patient takes their own vaginal sample, which is then submitted to a lab where Roche’s cobas molecular equipment is used for analysis. If an HPV test is positive, the patient would next see a doctor to continue their treatment.

According to Matt Sause, CEO of Roche Diagnostics, the World Health Organization’s 2030 cervical cancer elimination target can be reached through immunizations, diagnostic tools, and screening programs. “By eliminating obstacles and facilitating access to HPV screening, our HPV self-collection solution helps achieve this goal by enabling individuals to gather their sample for HPV testing discreetly.”

HPV is the recognized cause of over 95% of cervical malignancies. The cobas HPV Test, which is used for both primary screening and co-testing, is part of Roche’s cervical cancer portfolio. Although anomalies in the cervix may be detected by Pap smear, the cobas HPV test identifies 14 high-risk HPV genotypes that increase the risk of cervical cancer. Results for HPV 16, HPV 18, and 12 other high-risk pooled genotypes are included.

Roche’s cobas HPV test is authorized to be used with the HPV self-collection solution. The cobas 4800 and fully automated cobas systems provide the most efficient time to results, with up to 96 results in around three hours. The cobas 6800 system can produce 384 results in an eight-hour shift, while the cobas 8800 system can produce 1,056 results.

A varied range of patient segments was represented in the IMPACT trial design, which was utilized to evaluate the therapeutic advantages of the Roche cervical cancer portfolio. Among these participants were 21% Black, 24% Hispanic-Latino, and 0.3% American Indian or Alaskan Native. This variety was essential for an appropriate evaluation of dual stain performance in patient populations with higher HPV incidence rates.

Over 50% of patients in the United States diagnosed with cervical cancer have either never been tested or have only been checked sporadically. They do not take part in routine screening. By providing an alternative to clinician collection techniques and delivering accurate and dependable findings that empower physicians to make decisions regarding patient care, Roche’s self-collection solution can assist in lowering these obstacles.