NeuMoDx Molecular Announces CE Marking for Quantitative BKV Assay
Ann Arbor, MI USA and Milan, Italy (August 5, 2020) – NeuMoDx Molecular, a sample-to-result molecular diagnostic company focused on central laboratory customers, announced today CE Mark approval for its quantitative BK Virus (BKV) PCR assay. This key test was developed in partnership with Sentinel Diagnostics, an IVD company engaged in the development and production of diagnostic kits for Clinical Chemistry, Immunochemistry and Molecular Diagnostics, and strengthens the NeuMoDx transplant menu which already includes tests with CE Mark for Epstein–Barr virus (EBV) and cytomegalovirus (CMV) viral load monitoring for the management of immunocompromised patients such as those who have undergone organ transplantation.
Opportunistic viral infections are responsible for significant mortality and morbidity in transplant patients. Rapid monitoring of viral infection is essential in the surveillance and management in patients who may be immunocompromised. The NeuMoDx solution provides excellent performance along with enhanced workflow to improve the ability of viral load monitoring for the clinical management of infection in critical organ transplant patient population.
The Quantitative BKV virus assay is based on Sentinel Diagnostics’ STAT-NAT ® patented technology and is supplied in a ready-to-use lyophilized format. The assay is stable at room temperature for two years and provides state of the art performance.
NeuMoDx Molecular offers solutions that integrate the entire molecular diagnostic process – from extraction to detection – with the first results available in about 60 minutes for viral load tests. These innovative analyzers provide operators with the ability to load patient samples in a continuous, random-access workflow resulting in on-demand, high throughput sample processing with a true operator walkaway window of up to eight hours.
“We are extremely appreciative of the Sentinel Diagnostics team working through the COVID-19 pandemic and performing all the activities required for commercialization of this important assay. The availability of the NeuMoDx BKV Quant Assay, along with the previously commercialized NeuMoDx CMV and EBV Quant Assays, moves us significantly closer to providing a comprehensive transplant virology monitoring solution.” said Sundu Brahmasandra, PhD., President and Chief Operating Officer of NeuMoDx.
The proprietary NeuDry™ reagents used with the systems require no refrigeration and are extremely robust with an on-board stability of up to 60 days and ambient temperature shelf life of greater than one year. The unitized format of the NeuDry reagents significantly increases operating efficiency while minimizing the waste leading to enhanced cost control.
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.
About Sentinel Diagnostics (Sentinel CH. S.p.A.)
Sentinel Diagnostics (Sentinel CH. S.p.A) is an Italian company based in Milan focused on the development and production of In Vitro Diagnostics for the most advanced Clinical Chemistry, Immunochemistry and Molecular Diagnostics platforms. Besides the wide product portfolio in Clinical Chemistry, the FOB Gold ® line is Sentinel’s complete solution for colorectal cancer screening, which includes patented sampling devices and analytical systems. In the field of Molecular Biology, the STAT-NAT ® portfolio is the company’s answer to the market need for sensitive, ready to use and eco-friendly Molecular Diagnostics, which now includes a RT-PCR test for the detection of SARS-CoV-2 infection (COVID-19). For more information, visit www.sentineldiagnostics.com .
NeuMoDx™ Molecular, Inc.
Chief Commercial Officer
Sentinel Diagnostics (Sentinel CH. S.p.A.)
Head of Marketing