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To the Editor The special commentary, “Patient Safety and the Next Generation of HPV DNA Tests,” by Kinney et al1 asserted that the analytic and clinical sensitivity of the US Food and Drug Administration (FDA) newly approved Cervista human papillomavirus (HPV) test (Hologic, Bedford, MA) is too high for the test kit to be used clinically because it generates 2 to 4 times more positive results than the other FDA-approved Hybrid Capture 2 (HC2) HPV DNA test (Qiagen, Gaithersburg, MD). The authors further stated “any new test must demonstrate acceptable clinical performance based on the standards of reliable clinical sensitivity and specificity set by the community of experts,” designating Drs Stoler, Castle, Solomon, and Schiffman as the experts in a reference.2 The first author of the Special Commentary, Dr Kinney, should have known that neither of the 2 FDA-approved HPV DNA tests has been validated according to the experts’ set standards of “accounting for the majority (>90%) of CIN3+ [cervical intraepithelial neoplasia, grade 3 or more].” As a consultant to Digene in 2002, he presented data to the FDA in support of approval of the HC2 HPV assay, and stated on public record “because invasive cancer is not an option for an endpoint, CIN2+ was used as the clinically relevant endpoint instead.”3 At this FDA premarketing approval open session advisory meeting, the HC2 assay was proposed “for use as a general population screening test in conjunction with the Papanicolaou (Pap) smear for women age 30 and older, as an aid to determining the absence of high-grade cervical disease or cancer.”3 How to use HPV test results to determine the presence of high-grade cervical disease or cancer was not on the agenda for discussion. Now, postmarketing surveys have shown that about 95% of the referrals to colposcopic …