Ok, managed to find a way back in. It does say “this site is intended for healthcare professionals” in tiny writing at the top of the screen (I’m not any such thing). Here’s some quotes:
“The efficacy of the test was demonstrated in a clinical trial at 10 urology practices in the US, among 434 men (median age 65 years) who were scheduled to receive a prostate biopsy.”
“In the cohort, the median total PSA was 5.9 ng/mL, and the eventual prevalence of prostate cancer was 53.7%.
With a total PSA cut-off value of 4 ng/mL, which is considered the lower limit of a suspicious amount, the sensitivity of the Sangia Total PSA Test was 85.4% and the specificity, 30.3%. When combined with DRE, the test's sensitivity increased to 91%.
Additionally, the unique point-of-service test had a 95% correlation with a previously FDA-approved, lab-based test (Elecsys Total PSA Immunoassay, Roche Diagnostics) in a set of blood samples from 122 men.
The device measures total PSA values between 0.08 ng/mL and 15 ng/mL. For values above or below these two points, the device simply indicates either <0.08 ng/mL or >15 ng/mL.”