Quanterix Corp released results from a clinical evaluation of its Prostate Specific Antigen (PSA) test, a fifth-generation digital immunoassay, demonstrating that the assay is a reliable predictor of five-year biochemical recurrence (BCR)-free survival following radical prostatectomy (RP). The pilot study was published online by the British Journal of Urology International.

"These results have important implications for the way prostatectomy patients will be managed in the future," states Herbert Lepor, prostate cancer expert and Chairman of the Department of Urology at NYU School of Medicine. "Not only will physicians be able to reassure patients who are at low risk of recurrence following radical prostatectomy, but the identification of a reliable predictor of recurrence soon after surgery has important implications for the frequency of PSA testing and selection of candidates for adjuvant therapy. In addition to providing patients with peace of mind, implementation of this test could lead to a reduction in healthcare costs."

To determine the ability of this test to predict five-year BCR-free survival following RP, researchers utilized frozen serum specimens, provided by NYU Langone Medical Center and the Johns Hopkins University School of Medicine, from men who had undergone RP and who had no evidence of BCR using conventional PSA measurement methods. The Quanterix single molecule PSA assay, which has an analytical sensitivity 1,000-fold lower than conventional ultrasensitive PSA assays, was capable of accurately measuring PSA levels in all men following surgery. Researchers found that the PSA nadir value (lowest level of PSA following RP) was a significant predictor of BCR. A Kaplan Meir analysis demonstrated that 100% of men with low PSA nadir values did not develop BCR, whereas 63% of men with higher PSA values eventually recurred. The sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of the SiMoA PSA test was 100%, 75%, 69% and 100% respectively.

Source: Quanterix Corp