FDA warning letter FDA Warns of Potential False Positive Results With Roche Cobas Liat Rapid SARS-CoV-2, Flu Test The issues may relate to sporadically leaking assay tubes causing an obstructed optical path in the Cobas Liat analyzer or abnormal PCR cycling in the reaction tubes. FDA Letter Warns About False-Positive Results From Becton Dickinson SARS-CoV-2 Test The agency said it recommends that clinical laboratory staff and healthcare providers consider any positive result presumptive from the BD SARS-CoV-2 test. FDA Issues Warning Letter to Luminex The firm said in an SEC document that it received an FDA warning letter in connection with the agency's requirements for its Verigene SP instrument. HTG Molecular Warned by Nasdaq of Listing Non-Compliance The firm received a notice from Nasdaq on Oct. 4 saying its stock had not met the minimum $1-per-share closing price requirement for 30 consecutive business days. ACLA Urges FDA to Reconsider Recent PGx Enforcement Moves The industry organization issued a letter urging the agency to reconsider recent decisions to demand several laboratories stop offering pharmacogenetic testing. Aug 2, 2019 FDA Issues Notice on Qiagen Recall of QiaSymphony MDx Platform Filter Tips Apr 15, 2019 Inova Decides to End PGx Test Offerings in Response to FDA Warning Letter Apr 10, 2019 FDA Warning Letter to Inova Raises Questions About Agency Overreach Into Practice of Medicine Premium Jul 27, 2017 Meridian Bio Q3 Revenues Inch Down 1 Percent Nov 9, 2015 FDA Sends DNA4Life Untitled Letter Regarding Pharmacogenetic Report Product Aug 26, 2015 FDA Issues Cepheid Warning Letter for GMP Violations at Swedish Site Apr 22, 2015 Dako Resolves Issues Raised in 2013 FDA Warning Letter Dec 6, 2013 23andMe Suspends Health-Related Data Interpretation for New Customers Oct 7, 2013 Atossa Recalls Breast Cancer Test, Platform Amid FDA Concerns Sep 10, 2013 FDA Issues Warning Letter to Agilent's Dako Aug 24, 2011 Beckman Coulter to Cut 8 Percent of Workforce May 17, 2011 FDA Warns More DTC Genetics Firms Sep 29, 2010 23andMe Continuing GWAS into Disease Factors; Official 'Optimistic' Over FDA Talks Jul 27, 2010 Sequenom Preparing Response to FDA on Warning Letter Jul 22, 2010 More Genetic Test Firms Receive FDA Warnings Jun 11, 2010 FDA Warns Consumer Genomics Firms, Illumina on Selling Unapproved Dx Products May 13, 2010 FDA Seeks Information from Pathway Genomics on Genetic Test Product Feb 2, 2010 FDA Warned Millipore on H1N1 Test Marketing Breaking News Lunaphore Technologies, University of Bern Partner on Colorectal Cancer Study People in the News: New Appointments at Biocept, Novacyt, Centogene, Illumina, More In Brief This Week: Sophia Genetics, Twist Bioscience, Dante Labs, MGI, Codex DNA, More New Products Posted to GenomeWeb: SpeeDx, Bio-Techne, NuProbe, More DiaSorin Q2 Revenues Rise 20 Percent on SARS-CoV-2 Testing Demand Cepheid Gets $28M From BARDA for SARS-CoV-2 Tests The Scan Interfering With Invasive Mussels The Chicago Tribune reports that researchers are studying whether RNA interference- or CRISPR-based approaches can combat invasive freshwater mussels. Participation Analysis A new study finds that women tend to participate less at scientific meetings but that some changes can lead to increased involvement, the Guardian reports. Right Whales' Decline A research study plans to use genetic analysis to gain insight into population decline among North American right whales, according to CBC. Science Papers Tie Rare Mutations to Short Stature, Immunodeficiency; Present Single-Cell Transcriptomics Map In Science this week: pair of mutations in one gene uncovered in brothers with short stature and immunodeficiency, and more.