C-Path receives COA qualification from FDA for the Symptoms of Major Depressive Disorder Scale (SMDDS)

 Critical Path Institute‘s (C-Path) Patient-Reported Outcome (PRO) Consortium announces its first clinical outcome assessment (COA) qualification from the US Food and Drug Administration (FDA) for the Symptoms of Major Depressive Disorder Scale (SMDDS). This qualification of the SMDDSfor exploratory use represents a major milestone for the PRO Consortium and specifically for the Depression Working Group, and is the culmination of a multi-year collaboration between FDA’s Center for Drug Evaluation and Research (CDER) and the PRO Consortium.Continue reading

Beacon Biomedical Inc. Announces the Launch of Its BeScreened™-CRC Test for Colorectal Cancer Screening

Phoenix, AZ.—Beacon Biomedical Inc., a medical diagnostic development company and CLIA laboratory based in Phoenix Arizona, today announced the launch of BeScreened™-CRC, a blood-based laboratory developed test (LDT) for colorectal cancer (CRC) screening that is 95% accurate at detecting CRC in adults ages 50-75 years of age with an overall 91% sensitivity and 86% specificity for CRC stages I-IV. Preliminary study findings also indicate a greater than 60% sensitivity for detecting precancerous polyps (advanced adenomas).Continue reading