Devyser’s Gene Screening Test for Breast, Ovarian Cancers Approved in Europe

Devyser’s Gene Screening Test for Breast, Ovarian Cancers Approved in Europe
Devyser’s hereditary breast and ovarian cancer (HBOC) test has received a CE mark from the European Commission and is now approved as a diagnostic test for both cancers in Europe. The CE mark is a certification for products sold in the European Economic Area to indicate the product has met all legal standards, and has been evaluated to meet all safety, health, and environmental regulations. The test, which is based on the company’s patented next-generation sequencing (NGS) library preparation technology, can analyze the DNA sequence and identify mutations in 12 genes known to be involved in the development of breast and ovarian cancer with more than 99.9% sensitivity and specificity. Of note, sensitivity is a test’s ability to identify true positives, while specificity refers to its ability to detect true negatives. The HBOC test also has a user-friendly workflow, with ready-to-use reagents, a hands-on time of less than 45 minutes, and a total laboratory process time of five hours. The entire process — from collecting a patient’s DNA sample to obtaining test results — can be performed in less than 24 hours. “When Covid-19 testing took precedence over all other types of molecula
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