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 molecular diagnostics thousands of other patients had to wait for their test results, in many cases significantly delaying diagnosis and treatment,” Ulf Klangby, founding partner and CEO of Devyser, said in a press release. “Laboratories now face a massive testing debt as ordinary testing is resumed.”
“I am proud that Devyser now offers a game-changing solution for hereditary breast and ovarian cancer diagnostics that enables laboratories to deliver results in just 24 hours, faster than any other product on the market,” he added. “With hands-on time kept to a minimum, the lab can process large volumes quickly and deliver the critical results without any further delays.”
The HBOC test can be used in combination with the company’s BRCA test, which has been developed to detect mutations in the DNA repair genes BRCA1 and BRCA2, extending the screening to 14 cancer-associated genes. It may also be performed after a negative BRCA test.
Genetic testing of these genes not only helps guide treatment and management decisions, it can also guide testing of at-risk relatives, as the tests are specifically designed for heritable mutations.
Both screening tests are part of Devyser’s NGS Oncology suite, and are approved for breast and ovarian cancer diagnosis in Europe.
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