UCT makes an oral presentation at the 2nd International Conference on Global Health and Nutrition in Paris, France on November 17-18, 2022.
TITLE: Clinical efficacy of the novel biomarkers combination CA 15-3 and CA-62 for early-stage breast cancer detection.
Combination of different cancer markers is often used for predicting tumor growth, for the evaluation of the tumor response to therapy, and for increase in the positive diagnosis ratio. To assess the novel biomarkers combination CA 15-3 and CA-62 for early- stage breast cancer detection a double-blind prospective-retrospective clinical study was performed on 2 clinically validated sets using serum measurements of CA 15-3 ELISA and CLIA-CA-62 assays in 488 serum samples. Results were also compared to the pathology findings and to published data from mammography, MRI, ultrasound, and multi-cancer early detection test (MCED). A study included 300 BC patients with TNM classification (254 at Stages I & II, 20 with ductal carcinoma in situ (DCIS), and 26 Stages III&IV patients), 47 patients with breast benign diseases, and 141 healthy controls. A following combination of two biomarkers: 10 < CA15-3 <46 U/ml and CA-62 ≥ 6300 U/ml allows eliminating false positive results for DCIS & Stage I breast cancer detection with 75% Sensitivity at 100% Specificity (AUC =0.895). The CLIA-CA-62 overall sensitivity for BC was 92% (100% for DCIS) at 93% specificity and it decreased in invasive stages (Stage I=97%, Stage II=85% and Stage III=83%). For the CA 15-3 assay sensitivity was 27-46% at 80% specificity. Sensitivity for mammography was 63-80% at 60% specificity, depending on the stage and the parenchymal density. These results obtained in a blind study demonstrate that a combination of CA15-3 with CA-62 immunoassay could prove useful as a supplement to current mammography screening and other imaging methods and has a potential to be integrated into existing screening programs as a preliminary screening tool, thus increasing the diagnostic sensitivity in DCIS, Stage I and Stage II breast cancer detection.
Contact
Viatcheslav Kondratiev, CEO
Universal Cancer Technologies (UCT)
800 Petrolia Road, Unit 3
Toronto, ON M3J 3K4 Canada
Phone: 416-661-7890
Email: [email protected]
About UCT
UCT is an emerging biotechnology company that has developed a sensitive cancer test that can reliably measure the amount of N-glycoprotein CA-62 biomarker in a routine blood draw. The test can detect the majority of epithelial cancer types at all stages of the disease (Stage I through Stage IV), even before a patient may become symptomatic. Because of its non-invasive approach and rapid turnaround time UCT’s CA-62 biomarker test is ideal for screening as well as for monitoring the success of ongoing cancer treatments and identifying relapses in remission patients.