ResourcesVendorsMolecular DiagnosticsNeuMoDx1250 Eisenhower Pl Ann Arbor, MI, USA 48108Latest from NeuMoDxRegulatory ApprovalQiagen obtains CE Mark for tuberculosis blood testBy LabPulse.com staff writersQiagen’s Ipsogen JAK2 RGQ PCR kit and NeuMoDx systems and reagents have already received CE Marks under the new IVDR requirements; the firm has pledged to transition all of its products to meet the new EU IVDR regulations.February 15, 2023MonkeypoxQiagen adds monkeypox test to automated PCR platformBy LabPulse.com staff writersAddressing a need to improve surveillance of monkeypox, Qiagen announced that it has launched a research-use-only monkeypox test strip capable of detecting both variants of the virus.November 22, 2022Financial ResultsQiagen Q3 net sales decline 7% on COVID challenges, but full-year outlook improvesBy LabPulse.com staff writersSales of non-COVID-19 products increased 11% year over year to $417 million, while sales of COVID-19 products fell 48% year over year to $83 million.November 8, 2022BiosensorsWeek in Review: Siemens, Roche, Qiagen launch new testing products; glucose test market to reach $20.4B this year; biosensor developer Know Labs goes public; moreBy Leo O'ConnorDear LabPulse.com member,September 21, 2022CE markQiagen developing, releasing assays for NeuMoDx systemBy Jared BerberabeThe assays, which permit the identification and quantification of the Epstein-Barr virus (EBV) and human herpesvirus 6 (HHV-6), have received CE-IVD certification for use in countries in the European Union and other countries that accept the CE Mark, Qiagen said.September 15, 2022510(k)Qiagen's new HSV assay cleared in EuropeBy LabPulse.com staff writersWith this latest regulatory clearance, Qiagen is now offering 15 CE-IVD assays for use on NeuMoDx 96 and 288 systems, in addition to the capability to process laboratory-developed tests (LDTs), the company said.May 5, 2022PCRQiagen and BD settle PCR patent lawsuitBy LabPulse.com staff writersThe lawsuit had been filed in the U.S. District Court for the District of Delaware and involved the NeuMoDx 96 and NeuMoDx 288 clinical PCR systems that Qiagen acquired with its purchase of NeuMoDx in 2020.November 7, 2021PCRQiagen reaches biological sample milestoneBy LabPulse.com staff writersQiagen said that sample technology is one of its five pillars of growth, along with its Quantiferon immune-response technology, NeuMoDx integrated polymerase chain reaction (PCR) system, QIAstat-Dx syndromic testing system, and QIAcuity digital PCR portfolio.August 23, 2021InfluenzaQiagen secures EUA for COVID-19 testBy LabPulse.com staff writersNeuMoDx Flu A-B/ respiratory syncytial virus (RSV)/SARS-CoV-2 Vantage is a polymerase chain reaction (PCR) assay that will enable clinicians to identify the cause of respiratory viral infection, whether it's due to SARS-CoV-2, influenza, or RSV.March 28, 2021Emergency Use AuthorizationQiagen plans FDA resubmission of coronavirus rapid antigen testBy LabPulse.com staff writersDeveloped with Elume of Australia, the QIAreach test is designed to process 30 swabs per hour, according to the companies. Qiagen had filed for an emergency use authorization (EUA) of the product with the FDA, but voluntarily withdrew its application in November because there were some chemistry issues that needed to be addressed. The company says that with feedback from the agency it has resolved these and is ready to submit for an EUA.January 20, 2021CollaborationQiagen closes NeuMoDx dealBy LabPulse.com staff writersIn 2018, Qiagen purchased a 19.9% stake in NeuMoDx along with the right to acquire the remaining NeuMoDx stake at a price of $234 million. The final price for the remaining stake includes customary purchase price adjustments for cash, indebtedness, and transaction costs.September 17, 2020Mergers & AcquisitionsThermo Fisher's acquisition of Qiagen falls shortBy LabPulse.com staff writersThermo Fisher and Qiagen announced the $11.5 billion deal in March after an on-again, off-again courtship starting in November 2019. The companies portrayed the combination as complementary, with Thermo Fisher expanding its specialty diagnostics portfolio by adding Qiagen's capabilities in molecular diagnostics.August 12, 2020PCRNeuMoDx coronavirus test gets emergency authorizationBy LabPulse.com staff writersThe reverse transcription polymerase chain reaction (RT-PCR) test was designed for use on the company's high-throughput NeuMoDx 288 and 96 molecular systems in CLIA-certified hospitals and labs that perform high-complexity testing. Results are available in as little as 80 minutes, according to the company.March 31, 2020COVID-19NeuMoDx readies launch of automated SARS-CoV-2 assayBy LabPulse.com staff writersThe NeuMoDx SARS-CoV-2 assay is a real-time reverse transcription polymerase chain reaction (RT-PCR) test that can provide results in just over an hour, according to the company. It uses the company's NeuDry technology that enables automation of the SARS-CoV-2 assay; reagents and consumables do not have to be refrigerated and are shipped in a ready-to-use format for immediate processing.March 11, 2020Hospital Acquired InfectionNeuMoDx and Sentinel partner on PCR assaysBy LabPulse.com staff writersNew molecular diagnostics will be developed in a range of areas, including for use in post-transplant infections, parasitic and hospital-acquired infections, and respiratory infections. The collaborative work will incorporate Sentinel's Stat-NAT technology, which the companies said was designed to stabilize the activity of the PCR mix to boost shelf life, among other advantages.December 9, 2019
