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 Guardant Health Files Motions to Dismiss, Change Venue in Illumina Patent Lawsuit In Brief This Week: SQI Diagnostics, T2 Biosystems, Enhanc3D, QuidelOrtho, More Illumina, Precision Health Research Singapore Partner for 100K Genomes Population Study 23andMe Fiscal Q4 Revenues Increase 14 Percent Local Coverage Determinations Roundup: Castle Bio, SkylineDx Ancient Genome Sequence Provides Look at Ancestry for Individual Who Perished at Pompeii The Scan Blend of Omicron With Delta The Associated Press reports that currently circulating Omicron variants have some features previously seen in the Delta variant. Limited Contrast The New York Times reports that there is a shortage of a contrast agent used for some medical scans. Pig Improvement Farmers in China are using genetics to improve their hog herds, according to Reuters. Science Papers Present Way to Molecularly Classify Prostate Cancer, Saliva-Based SARS-CoV-2 Test, More In Science this week: approach to molecularly classify prostate tumors, saliva-based test for SARS-CoV-2, and more.