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APTIMA HPV Assay, FDA-Approved HPV DNA Test · 1 trial · 1 indication
Adjunct 30+ yrs. Population: Aptima HPV Assay Performance for Detecting CIN2+: Compare Clinical Performance of the Aptima HPV Assay to a FDA-Approved HPV Assay for Detecting CIN2+
Adjunct Study Arm: 30+ yrs. Population: FDA-Approved HPV DNA Assay Performance for Detecting CIN2+: Compare Clinical Performance of the Aptima HPV Assay to a FDA-Approved HPV Assay for Detecting CIN2+
| Arm | Type | Description |
|---|---|---|
| Adjunct (i.e. Normal Pap) | OTHER | The Adjunct study will evaluate APTIMA HPV Assay clinical performance for detecting high-risk HPV types in female subjects 30+ years of age with negative (NILM) cytology results from routine Pap testing. This will be accomplished by evaluating the assay performance compared to known cervical disease status at baseline and after a 3-year follow-up period. A comparator FDA-Approved HPV DNA test is reported. |
| ASC-US | OTHER | The ASC-US study will evaluate the APTIMA HPV Assay clinical performance for detecting high-risk HPV types in subjects with ASC-US Pap test results from routine Pap testing and known cervical disease status (based on colposcopic biopsy results). A comparator FDA-Approved HPV DNA test is reported. There is no follow-up period. |
| Name | Type | Description |
|---|---|---|
| APTIMA HPV Assay | DEVICE | The APTIMA HPV Assay is an in vitro nucleic acid amplification test (NAAT) that qualitatively detects human papillomavirus (HPV) E6/E7 messenger RNA (mRNA) from 14 HPV types (types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) that are associated with cervical cancer ("high-risk types"). The assay cannot determine the specific high-risk HPV type(s) present and does not cross-react with 5 HPV types that are considered non-oncogenic (not associated with cervical cancer; types 6, 11, 42, 43, and 44). |
| FDA-Approved HPV DNA Test | DEVICE | A FDA-Approved HPV DNA Test is used as the comparator assay. |
Inclusion Criteria: * Female 21 years or older (ASC-US study only) * Female 30 years or older (Adjunct and ASC-US studies) * Subject attending a participating clinic and undergoing a Pap screening exam during the clinic visit * Ability to comprehend and sign an IRB-approved Informed Consent Form E...
APTIMA HPV Assay is a diagnostic test used for the detection of Human Papillomavirus (HPV) infection. It is an FDA-approved HPV DNA test that identifies the presence of HPV, which is a common sexually transmitted infection associated with cervical cancer and other conditions.
APTIMA HPV Assay is developed by Hologic, Inc., a company traded on the NASDAQ under the ticker symbol HOLX. Hologic is a medical technology company that specializes in diagnostic products, including women's health and infectious disease testing.
APTIMA HPV Assay is in Phase 3 clinical development. It is an investigational diagnostic test that has completed a Phase 3 clinical trial. The test is FDA-approved, meaning it has received regulatory approval for use in the United States.
APTIMA HPV Assay has been evaluated in one completed Phase 3 clinical trial, identified as NCT00973362. This trial, titled 'Clinical Evaluation of the APTIMA® HPV Assay Using the TIGRIS® System,' enrolled 12,896 female participants aged 21 years and older in the United States.
Yes, APTIMA HPV Assay is FDA approved. It is an FDA-approved HPV DNA test that has completed Phase 3 clinical development. The test is designed to detect Human Papillomavirus infection and is available for clinical use.