Point-of-care testing with the LuViva® Advance Cervical Scan developed by
Guided Therapeutics, Inc.
, (OTCBB: GTHP) (OTCQB: GTHP) combined with human papillomavirus (HPV) testing, could optimize early detection of cervical cancer and reduce by approximately one-third the number of unnecessary biopsies that result from the false positive rate of Pap tests, according to an analysis presented at the American Congress of Obstetricians and Gynecologists 60
Annual Clinical Meeting in San Diego.
Combining the two tests created a sensitivity of 99% and a negative predictive value (NPV) of 99%, according to the poster presentation entitled “
Optimal combination of cervical spectroscopy with cytology and HPV: Implications for clinic efficiency
.” HPV testing alone generated a sensitivity of 81%. Sensitivity is the ability to correctly identify moderate and high-grade dysplasia; negative predictive value is the percentage of subjects with a negative test result who are correctly diagnosed. The poster was authored by Dr. Marc L Winter of the Orange Coast Women’s Medical Group and Dr. Daniel Sternfeld of the Saddleback Women’s Medical Group, both of Laguna Hills, California.
“The implications of the study are fewer women undergoing painful and unnecessary biopsies, lower costs to the healthcare system, better care for women with disease and a more efficient practice for the physician,” said Dr. Winter.
“LuViva would also be the first women’s cancer detection tool that gives an immediate result, which could mean either instant relief, if negative, or the immediate initiation of treatment, if necessary,” said Dr. Sternfeld. “We believe this will strengthen the doctor-patient relationship and ultimately lead to a reduction in cervical disease.”
Data were analyzed from a prospective Phase III study that enrolled 1,607 women referred to colposcopy and biopsy at seven U.S. centers, including 804 women that returned for follow up. On the day of study, each woman underwent a LuViva scan, had a specimen taken for cytology, an HPV test and colposcopy. Biopsy specimens were reviewed by a panel of histopathologists to determine a final diagnosis by which LuViva and the other tests were compared.