To help catch more cases of cervical cancer and precancer before they can grow and spread, BD has snared a European approval for an at-home test for human papillomavirus, or HPV.
With more than half of all cervical cancers found in women who've never been screened before or missed their examinations for at least five years—and almost all cervical cancers caused by HPV—routine testing for the virus is essential to fending off a largely preventable disease.
And while widespread use of Pap tests has dramatically cut the number of deaths from cervical cancer, many women have postponed regularly scheduled check-ups during the past year's international pandemic, BD’s integrated diagnostic solutions president, Brooke Story, said in a statement.
"As a woman, I can say that a fear of exposure to COVID has impacted my own preventive health behavior, so I recognize both professionally and personally the value of having an easy, convenient and private self-collection process for HPV screening available," Story said.
According to a January report from the Centers for Disease Control and Prevention, stay-at-home orders to stop the spread of the coronavirus dragged down cancer screening rates on a wide scale. In one example, cervical cancer testing among 1.5 million women at a Southern California health system dropped by 80% before returning to near-baseline levels.
The new CE mark expands the use of the company’s laboratory-based Onclarity assay to include self-collected vaginal swab samples mailed in for analysis—as the pandemic has put new value on at-home diagnostic tests for a wide range of conditions.
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BD’s real-time PCR test, itself approved by the FDA last July, identifies 14 different strains of HPV to help identify women who may be at the highest risk of developing tumors. HPV infections cause virtually all cases of cervical cancer worldwide.
Two genotypes alone, HPV 16 and 18, account for more than 70% of cancerous and precancerous lesions, which can both be treated if caught early. Other companies in the U.S., such as home diagnostic provider Everlywell, have marketed self-collected HPV tests, but they account for a smaller number of genotypes.
“Not only does self-collection afford women greater access to testing, but they may also feel confident that the reliability of HPV testing of self-collected samples is the same as if they went to a clinician," said Jeff Andrews, BD’s vice president of global medical affairs.
Late last year, the World Health Organization launched a global strategy aimed at eliminating cervical cancer, calling for a three-pronged approach encompassing HPV vaccination, screening and treatment. Meanwhile, the EU has set a target of 70% screening coverage across the most vulnerable age group, including through self-collected samples.