The current standard of care is to use the Pap test for women ages 21 to 29 and a combination of both the Pap test and HPV test (cotesting) for women between the ages of 30 and 65. The ACS guidelines, which were published July 30, would shift to HPV testing only, and Hologic claims this would erode access to preventative healthcare and could sow confusion among women and their healthcare providers.
"We urge the ACS to live up to its mission of freeing the world from cancer by reconsidering its cervical cancer guidelines so women can continue to have access to the proven-effective tests they not only need but deserve," the firm added.
Another key change in new ACS guidelines is that screening starts at age 25, rather than 21.
"[I]t is unclear why the ACS would want to put women's health at risk by moving toward a future screening paradigm in which the preferred approach does not include the Pap test, and younger women -- those under 25 years of age -- would be excluded from screening altogether," Hologic said in a press statement.
The company also argues that the new ACS guidelines significantly diverge from those of other medical and governmental institutions including the American College of Obstetricians and Gynecologists, the U.S. Preventive Services Task Force, and the Women's Preventive Services Initiative.
However, there has been a trend toward primary HPV screening, as evidenced by risk-based management consensus guidelines published in 2019 by the American Society for Colposcopy and Cervical Pathology (Journal of Lower Genital Tract Disease, April 2020, Vol. 24:2, pp. 87-89).
Hologic stands to lose under the new guidelines. The ACS has recommended products specifically approved by the U.S. Food and Drug Administration for primary HPV screening. Only two are approved for this use -- Roche's cobas HPV and Onclarity HPV from Becton Dickinson. Hologic's Aptima and Cervista brand HPV tests are cleared for cotesting, as is Qiagen's digene.
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