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NeuMoDx Molecular Announces CE Marking for HIV Viral Load Assay

– Completes menu for key blood born viral tests –

June 15, 2020 (Ann Arbor, MI) – NeuMoDx Molecular, a sample-to-result molecular diagnostic company focused on central laboratory customers, announced today CE Mark approval for its PCR Human Immunodeficiency Virus (HIV) viral load test. This key test completes the NeuMoDx blood born viral menu which already includes tests for Hepatitis B virus (HBV) and Hepatitis C virus (HCV) viral loads.

NeuMoDx Molecular offers solutions that integrate the entire molecular diagnostic process – from extraction to detection – with the first results available in about 80 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 excited to expand our blood borne virology test menu by adding the NeuMoDx HIV-1 assay for detection and quantitation of HIV-1 RNA on the automated NeuMoDx 96/288 Molecular systems”, said Sundu Brahmasandra, NeuMoDx President and COO. “We are committed to continued assay development to further assist laboratories and the patients they serve”.

Today’s clinical laboratories are challenged to increase productivity through process optimization and cost management. Laboratories gain unique opportunities to maximize effectiveness with three distinct modes of operation (IVD, LDT, and Extraction Only) for the NeuMoDx Molecular Systems. 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.

About NeuMoDx™

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.

Coronavirus Assay Information

NeuMoDx™ Molecular, a sample-to-result molecular diagnostic company focused on providing testing solutions to hospital and commercial reference laboratories, has developed a SARS-CoV-2 Assay for use on the high throughput, fully automated NeuMoDx™ 288 and 96 Molecular Systems. The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the NeuMoDx™ SARS-CoV-2 Assay implemented on the NeuMoDx™ Molecular Systems.

To learn more about SARS-CoV-2 testing, click here.
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