cytomegalovirus Roche BK Virus Test Garners FDA Clearance The RT-PCR test runs on the Cobas 6800/8800 Systems and had previously received breakthrough device designation from the FDA. DiaSorin Molecular Gets CE Mark for Congenital CMV Assay The disease occurs when cytomegalovirus infection is passed from a mother to an unborn child and can lead to severe and potentially fatal outcomes. NeuMoDx Gets CE Mark for Cytomegalovirus, Epstein-Barr Virus Tests NeuMoDx's tests are designed for central laboratory use and run on the company's fully automated NeuMoDx 96 or 288 real-time PCR systems. Arc Bio Introduces Sample-to-Answer RUO NGS Kit for Transplant Viruses; Beta Users Report Data at CVS Premium The company plans to take a tiered approach to assay development, targeting its first test to 10 viruses commonly detected in transplant patients. Advanced Biological Labs, Mayo Collaborate on Test for CMV Antiviral Resistance The test will leverage next-generation sequencing to sequence PCR amplicons of the UL54 and UL97 genes in which drug resistance with CMV has been associated. Nov 30, 2018 FDA Clears Meridian Bioscience's Newborn Cytomegalovirus Test Jul 19, 2018 French Firm Life and Soft Aims to Use NIPT Data to Screen for Infectious Disease Premium Jun 27, 2017 FDA Approves Abbott's Molecular CMV Assay Jun 6, 2017 Qiagen Gets FDA Approval for CMV Assay on QiaSymphony Platform May 25, 2016 Roche CMV Test for Hematopoietic Stem Cell Transplants Gets FDA OK Oct 26, 2015 European Trial of Beckman Coulter DxN Veris Shows Workflow Improvements for MDx Testing Premium Aug 5, 2015 Beckman Coulter Builds Test Menu on Veris MDx Platform; US Launch Still Few Years Out Premium Jul 6, 2015 Human Cytomegalovirus Harbors Hot, Cold Spots of Genetic Diversity, Report Finds Jun 25, 2015 Lophius Biosciences Signs Exclusive Korean Distribution Agreement with BL&H May 27, 2015 EliTech Targeting Transplant Pathogen Monitoring with Sample-to-Answer qPCR Platform Premium Dec 22, 2014 Roche's Cobas CMV Viral Load Assay Gets CE Mark Dec 15, 2014 Study Shows Promise of NGS, qPCR to Detect Vaccine Contaminants Premium Sep 18, 2014 Baebies Enters Phase II of NIH Funding for Droplet-based Neonatal Saliva Screen for CMV Premium Jul 17, 2014 Dx Focus: Alere q HIV-1/2 Assay; DiaSorin CMV Test Premium Jun 19, 2014 Qiagen CMV Assay Wins FDA Approval May 22, 2014 Beckman Coulter Launches Long-Awaited MDx System, CMV Assay in Europe Premium May 8, 2014 Lophius Bio Receives $2.8M Financing, Names New CEO Nov 23, 2012 Researchers Uncover Hundreds of New Open Reading Frames in Human Cytomegalovirus Nov 2, 2012 At NGS-Heavy AMP Meeting, Clinical Researchers Still Get Behind PCR for Infectious Disease Dx Premium Sep 20, 2012 Dx Focus: Roche's CMV Viral Load Test; Meridian's Illumigene Group A Strep Assay Premium Load More Breaking News Children With Autism May Have Underdeveloped Gut Microbiomes, Metagenomic Analysis Finds Kiromic BioPharma Acquires InSilico Solutions Bio-Rad Laboratories, 10x Genomics Settle IP Lawsuits, Sign Global Cross-Licensing Agreement Scope Fluidics Obtains CE Mark for PCR-Based SARS-CoV-2 Panel MeMed COVID-19 Prognostic Test Receives CE Mark ERS Genomics Licenses CRISPR IP to Japan SLC The Scan Dropped Charges The US Justice Department has dropped visa fraud charges against five Chinese researchers, according to the Wall Street Journal. More Kids The Associated Press says Moderna is expanding its SARS-CoV-2 vaccine study to included additional children and may include even younger children. PNAS Papers on Rat Clues to Human Migration, Thyroid Cancer, PolyG-DS In PNAS this week: ancient rat genome analysis gives hints to human migrations, WDR77 gene mutations in thyroid cancer, and more. Purnell Choppin Dies Purnell Choppin, a virologist who led the Howard Hughes Medical Institute, has died at 91, according to the Washington Post.