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FDA Clears NeuMoDx MDx System, GBS Assay

NEW YORK (GenomeWeb) – The US Food and Drug Administration has granted 510(k) clearance to a high-throughput molecular diagnostics platform and Group B Strep assay from Ann Arbor, Michigan-based NeuMoDx Molecular.

The 288 Molecular System is an automated sample-to-answer diagnostics platform that runs up to 288 patient samples in continuous random-access mode. The time to first results is approximately one hour, according to the firm, with a walkaway window of more than six hours, and NeuMoDx intends the system to be used in central labs of hospitals and clinical reference laboratories.

The system uses a unitized format of dried reagents, eliminating the need for bulk, manual reconstitution, and the reagents require no refrigeration and have on-board stability in the system of more than 60 days.

Testing for GBS colonization is usually performed in the third trimester of pregnancy to prevent complications of transmission to a newborn during labor and delivery. The NeuMoDx GBS Assay is a qualitative PCR-based diagnostic test to detect an 88 base-pair region of the pcsB gene and incorporates sample lysis, automated DNA extraction, and real-time PCR. The firm said the assay showed a sensitivity of 97 percent and specificity of 96 percent compared to culture in a multicenter clinical performance study.

The GBS test "fulfills the market need for a rapid, cost-effective, and easy-to-use testing of GBS colonization status on a high-throughput molecular diagnostic system," NeuMoDx's president, Sundu Brahmasandra, said in a statement.

NeuMoDx is also developing other tests for the 288 Molecular System, including a menu of assays for infectious diseases and sexually transmitted infections.