CLIA TruDiagnostic Receives CLIA Certification for Kentucky Laboratory The Lexington, Kentucky-based firm also launched a new portal interface focused on epigenetics and reporting laboratory test interpretations. Applied DNA Sciences Subsidiary Gets CLIA Certification From NY State Department of Health The company said it can now perform high-throughput SARS-CoV-2 testing with assays that have received Emergency Use Authorization from the FDA. Binx Health Chlamydia and Gonorrhea Test CLIA Waived The 30-minute test can be used on samples from males and females in settings operating under a CLIA certificate of waiver. Lucence Obtains CLIA Certification for Palo Alto Lab The firm will scale US-based testing capacity for its LiquidHallmark liquid biopsy assay, which uses amplicon-based technology to detect cancer-related mutations. Mesa Biotech Receives 510(k) Clearance, CLIA Waiver for Strep A Molecular Point-of-Care Test The firm said its test fits in the palm of a hand and delivers results in 30 minutes by detecting bacterial nucleic acid in throat, nasal, or nasopharyngeal swabs. Nov 11, 2020 Adaptive Biotechnologies Prepares to Launch T Cell-Based COVID-19 Test Premium Aug 17, 2020 Fulgent Genetics Opens CLIA-Certified Lab in Houston, Raises Revenue Guidance Jan 29, 2020 IDbyDNA Raises $20M in Series B Financing Oct 14, 2019 Avellino Labs Gets CLIA Certification Jun 26, 2019 Oncocyte Shares Tank on News of Delayed CLIA Validation Study for Liquid Biopsy Lung Cancer Test Feb 25, 2019 CareDx Expands AlloSure Transplant Test to Lung, Starting With Compassionate Use Premium Jan 30, 2019 OncoCyte Readies Lung Cancer Test for Launch, Previews New Platform Validation Data Premium Nov 27, 2018 Mesa Biotech Respiratory Tract Infection Test Gets FDA Clearance, CLIA Waiver Oct 25, 2018 Abbott Molecular Flu, Strep Tests Get FDA Clearance Aug 8, 2018 FDA Details Vision for Regulating In Vitro Clinical Tests to Legislators Jul 26, 2018 Cepheid Flu/RSV Test Gets FDA Clearance, CLIA Waiver Jul 16, 2018 Predicine Gets CLIA Certification for Sequencing Lab Jun 22, 2018 Some Stakeholders Not on Board With Draft Bill on New Dx Regulatory Framework Premium May 2, 2018 Cepheid Xpert Xpress Strep A Test Gets CLIA Waiver May 1, 2018 Novogene Gets CLIA Certification for US Lab Jan 9, 2018 Cepheid GeneXpert Xpress, Influenza MDx Receive FDA 510(k) Clearance, CLIA Waiver Dec 22, 2017 Quidel Solana GBS, Sofia2 Group A Strep Tests Clear FDA Nov 28, 2017 Celmatix Receives NY State Approval for Reproductive Health Gene Panel Sep 8, 2017 BGI Receives CLIA Certification for Hong Kong Lab Sep 7, 2017 OncoCyte Receives CLIA Certification for Cancer Dx Lab Load More Breaking News Enzo Biochem, CLX Health Partner to Support COVID-19 Testing for International Travel Type 1 Diabetes GWAS, Fine-Mapping Leads to New Genetic Loci, Potential Drug Targets LSU Health Sciences Center Wins $2.4M to Lead SARS-CoV-2 Variant Sequencing Program NanoString Technologies, Parker Institute for Cancer Immunotherapy Partner on Cell Therapy Project BGI Americas Collaborating With Champions Oncology on Proteomic Cancer Research Personal Genome Diagnostics Inks Cancer Genomic Profiling Deal with Duke University Health System The Scan Missed Early Cases A retrospective analysis of blood samples suggests early SARS-CoV-2 infections may have been missed in the US, the New York Times reports. Limited Journal Editor Diversity A survey finds low diversity among scientific and medical journal editors, according to The Scientist. How Much of a Threat? Science writes that need for a provision aimed at shoring up genomic data security within a new US bill is being questioned. PNAS Papers on Historic Helicobacter Spread, Brain Development, C. difficile RNAs In PNAS this week: Helicobacter genetic diversity gives insight into human migrations, gene expression patterns of brain development, and more.