H1N1 Q&A: North Shore-LIJ's Ginocchio on Decentralizing Molecular Testing for Infectious Disease Premium NAME: Christine Ginocchio International Team Detects Gene Variant Influencing Flu Susceptibility Dx Focus Apr 28, 2011: Clinical and Regulatory PCR and Nucleic Acid Testing News Premium Quest's Focus Diagnostics gets CE Mark for Simplexa EBV and BK virus tests; Cepheid gets FDA nod for Xpert Flu test. Quest's Focus Dx Business Gets FDA OK, CE Mark for Flu A/B and RSV Test on 3M Cycler Premium Quest Diagnostics has received 510(k) clearance from the US Food and Drug Administration for its Focus Diagnostics Simplexa Flu A/B and RSV test on the 3M Integrated Cycler. Biosearch Technologies Licenses New Flu Signatures from CDC Premium Biosearch has licensed from the US Centers for Disease Control and Prevention new H1N1 influenza probes and primers for more sensitive and specific H1N1 detection assays. Oct 28, 2010 UCSF Researchers Back Cepheid Flu Test as Attractive Alternative to Most Current Lab Methods Premium Sep 17, 2010 AITBiotech Licenses Multiple Assays Aug 26, 2010 Focus Diagnostics Awaits CE Mark, FDA Clearance for Combined Flu/RSV Test on 3M Instrument Premium Jul 1, 2010 As FDA's 2009 H1N1 EUAs Expire, PCR Test Makers Refine Plans for Next Flu Season Premium May 26, 2010 Recent Studies Prop Up Multiplex PCR Testing for Respiratory Viruses Premium May 13, 2010 IQuum 'Lab-in-a-Tube' PCR Test for H1N1 Flu Gets FDA Emergency Use OK Premium May 11, 2010 InDevR to Develop Influenza Assay with CDC Mar 10, 2010 Biosearch Seeks to Enter IVD Market with Expanded Roche License Premium Feb 24, 2010 Dx Focus Feb 24, 2010: Clinical and Regulatory PCR and Nucleic Acid Testing News Premium Feb 4, 2010 Dx Focus: Clinical and Regulatory PCR and Nucleic Acid Testing News: Feb 4, 2010 Premium Dec 31, 2009 JCM Studies Suggest Viral Variants Confound PCR-based Influenza A, H1N1 Tests Premium Dec 21, 2009 TessArae Gets FDA Emergency Use Authorization for H1N1 Assay Dec 14, 2009 FDA Clears DxNA's H1N1 Test for Emergency Use Nov 16, 2009 Roche Gets FDA EUA for H1N1 Test Kit Nov 12, 2009 EU Clears Prodesse’s H1N1 Test Nov 4, 2009 Biosearch Technologies Licenses H1N1 Flu IP from CDC Nov 3, 2009 FDA Publishes Guidance Document for H1N1 Dx Oct 29, 2009 Gen-Probe Gets FDA Emergency Use Authorization for Flu Test Oct 26, 2009 3M Ships First Thermal Cycler in Partnership with Quest; Firms Eye Hospital Lab Market for Compact System Oct 20, 2009 Flu Testing Fuels Revenue Growth in Roche's PCR, Purification Business This Year Load More Breaking News Euformatics Forms Distribution Partnership for Eastern Europe With Bulgaria's Elta 90 Oxford Nanopore, University of Queensland Partner for Sequencing-Based mRNA Vaccine Quality Control Human Brain Circular RNAs Linked to Neuron Type, Neuropsychiatric Conditions New High-Throughput AAV CRISPR Screening Method Could Enable Study of Diverse Tissue Types Day Zero Diagnostics Closes $16M Financing Round The Scan Positive Framing of Genetic Studies Can Spark Mistrust Among Underrepresented Groups Researchers in Human Genetics and Genomics Advances report that how researchers describe genomic studies may alienate potential participants. Small Study of Gene Editing to Treat Sickle Cell Disease In a Novartis-sponsored study in the New England Journal of Medicine, researchers found that a CRISPR-Cas9-based treatment targeting promoters of genes encoding fetal hemoglobin could reduce disease symptoms. Gut Microbiome Changes Appear in Infants Before They Develop Eczema, Study Finds Researchers report in mSystems that infants experienced an enrichment in Clostridium sensu stricto 1 and Finegoldia and a depletion of Bacteroides before developing eczema. Acute Myeloid Leukemia Treatment Specificity Enhanced With Stem Cell Editing A study in Nature suggests epitope editing in donor stem cells prior to bone marrow transplants can stave off toxicity when targeting acute myeloid leukemia with immunotherapy.