NeuMoDx™ Molecular Announces FDA 510(k) Clearance for its N288 Molecular System and GBS Assay
Ann Arbor, Michigan (July 2018) – NeuMoDx™ Molecular, a sample-to-result molecular diagnostic company focused on central laboratory customers, announced today it has received FDA 510(k) clearance for its NeuMoDx™ 288 Molecular System and its NeuMoDx™ GBS Assay.
The fully automated NeuMoDx™ 288 Molecular System is the first offering in a family of scalable platforms that integrate the entire diagnostic process – from extraction to detection or ‘sample to result’ – in approximately one hour to first result. This innovative analyzer offers the ability to load up to 288 patient samples in a continuous random-access mode resulting in an on-demand, high throughput sample processing workflow with a true operator walkaway window of more than six hours.
The revolutionary dry format reagents require no refrigeration and are extremely robust with an on-board stability of greater than 60 days, and ambient temperature storage shelf life of greater than one year. Additionally, the unitized format of the dry reagents significantly increases operating efficiency while minimizing the waste associated with systems requiring manual reconstitution and/or use of bulk format lyophilized reagents. “I would like to thank the entire NeuMoDx™ team for the work they have accomplished in the design and development of these revolutionary molecular diagnostic solutions and am excited about the real benefits they will deliver to our central laboratory customers and the patients they serve,” commented Jeff Williams, Chairman and CEO, NeuMoDx™ Molecular.
About Group B Streptococcus
Group B Streptococcus (GBS) is a Gram-positive bacterium found in 10-35% of healthy adults and is a commonly found bacteria within the human body. A person who carries GBS and does not present symptoms of GBS disease is said to be “colonized” with GBS. GBS colonization is not considered contagious, however, under certain circumstances, GBS can invade the body and cause serious infection; this is referred to as Group B Streptococcal disease. It is a leading cause of life-threatening bacterial infection in newborns who acquire the disease during birth by vertical (mother-to-baby) transmission. Approximately 2000 cases of newborn infections occur per year, with estimates of a mortality rate of 0.27 per 1000 live births
The NeuMoDx™ GBS Assay as implemented on the NeuMoDx™ 288 Molecular System (NeuMoDx™ System) is a qualitative in vitro diagnostic test designed to detect Group B Streptococcus (GBS) DNA from antepartum pregnant women. The assay incorporates sample lysis and automated DNA extraction to isolate nucleic acid from the specimen, and real-time polymerase chain reaction (PCR) to detect an 88 bp region of the pcsB gene sequence in the Streptococcus agalactiae chromosome. Results from the NeuMoDx™ GBS Assay can be used as an aid in determining colonization status in antepartum women. In a multi-center clinical performance study, the NeuMoDx™ GBS Assay results yielded a sensitivity of 96.9% and specificity of 96.0%, when compared with the gold standard culture method.
“The achievement of 510(k) clearance of the NeuMoDx™ GBS Assay on the NeuMoDx™ 288 Molecular system 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”, Sundu Brahmasandra, President of NeuMoDx™ commented.
NeuMoDx™ is developing additional tests to detect and monitor Infectious and Sexually Transmitted Diseases to significantly enhance the test menu offering and complement the NeuMoDx™ GBS Assay that can currently be processed on the NeuMoDx™ 288 Molecular System.
NeuMoDx™ Molecular designs and develops revolutionary molecular diagnostic solutions for hospital and clinical reference laboratories. Our patented, ‘sample-to-result’ platform offers market-leading ease of use, true continuous random-access, and rapid turnaround time while achieving optimal operational and clinical performance for our customers and the patients they serve. For more information visit www.neumodx.com.