VagiGuard Home Collection Device
The VagiGuard device is a simple collection device that women can use in the privacy of their own home to self-collect a sample that can be returned to the laboratory for analysis. Analysis can include cervical cancer screening with molecular HPV testing.
Women’s pelvic organs including the vagina and cervix are prone to develop infections from both bacteria and virus during adulthood. Many are sexually transmitted. Early detection of cervical cancer, which the majority are linked to the HPV virus, makes treatment quick and easy and drastically lowers morbidity and mortality.
VagiGuard will increase compliance for cervical cancer screening via HPV testing as well, especially for minimal or asymptomatic individuals.
VagiGuard Safety:
The VagiGuard device is recommended for use in adults who would be recommended for routine STD or PAP screening and/or testing of HPV. The VagiGuard device does not directly detect cancers and should be used in addition to routine cancer screening tests recommended by a healthcare provider. The VagiGuard device is intended to help capture cellular material that can be used to detect HPV, a common virus that is linked to cervical cancer.
The VagiGuard device is not currently recommended in individuals who are pregnant, 21 years old or younger, or undergoing active cancer treatment or have a known infection or medical condition that would interfere with the device. Results should be interpreted by a healthcare provider in the context of medical history, clinical signs and symptoms. A positive cancerous or pre-cancerous test requires a confirmatory diagnostic evaluation by medically established procedure such as a Papanicolaou or Pap smear test, or colposcopy, to confirm the findings.
As a screening test, false-positive (a HPV signal detected when HPV is not present) and false-negative (a HPV signal not detected when HPV is present) test results can and do occur.
VagiGuard Laboratory / Test Information
The VagiGuard device and associated tests are currently being developed, and its performance characteristics being determined by White Coat Science.
The VagiGuard device has not been cleared or approved by the U.S. Food and Drug Administration. The VagiGuard device is a sample collection device. Diagnostics are performed on proven and standardized diagnostic systems.
This site is for pre-market information only and is not considered medical advice. Subscribe to our waitlist to be placed on our prospective patient list to be notified when the VagiGuard collection device becomes available.