Third Wave’s 14-type high-risk human papillomavirus (HPV) test demonstrated a negative predictive value greater than the study’s 99% goal. Negative predictive value is the probability that there is no cervical disease in a patient with atypical or Ascus Pap test results and negative HPV test results.
The company’s proprietary high-risk HPV test is intended to be used in combination with a Pap test to assess women 30 and over, for the presence of high-risk HPV types and to guide their treatment. It is also intended to test patients with abnormal Pap results to determine whether they should be referred to colposcopy.
Third Wave believes that its high-risk HPV test demonstrated performance in the clinical trial that met the key performance criteria established by the Alts clinical trial, the foundational HPV screening study sponsored by the National Cancer Institute.