Collection of Healthcare News and Biomedical Development — Jan. to April. 2023

This story may include the following topics: Medical Devices, Biomedical Research, Regulations and Quality Management Systems, Entrepreneurship, Pharmaceuticals and Biology, Healthcare System and IT, Diagnostics, Reimbursement and Health Insurance, Neuroscience and Neuromodulation, Gene and Genomics, Public Health and Global Health, …

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Last updated on May. 07, 2023 at 09:55 PM (PDT)

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In Vitro Diagnostic (IVD) Devices, CLIA, Diagnostic Industry, Genetic Testing, Next Generational Sequencing (NGS), Genomics,

Guardant360 CDx - P200010/S010

Premarket Approval (PMA)

Guardant Health Nabs FDA Approval for Liquid Biopsy CDx With Menarini Breast Cancer Drug

FDA approves elacestrant for ER-positive

Guardant Health, AnHeart Tx to Develop Blood- and Tissue-Based CDx for NSCLC Drug

FDA Approves Elacestrant for ER+/HER2- Advanced Breast Cancer

Cue Health Gets FDA EUA for Monkeypox Molecular Test

Guardant Health, Ohio State University Partner on Blood-Based Colon Cancer Screening Study

JP Morgan Healthcare Conference, Day 1: Guardant Health, Exact Sciences, QuidelOrtho, More

Guardant Health Confident in 2023 Growth Despite Lower-Than-Expected Revenue Guidance

Biosynex to Acquire Chembio Diagnostics for $17.2M

Liquid-biopsy firm Grail is spending more than ever lobbying Congress

Labcorp, VieCure Collaborate on NGS, Software for Cancer Diagnosis

GeneDx to Raise $150M in Public and Direct Stock Offerings

Ravgen NIPT Patents Withstand Illumina Challenge

BioMérieux SpotFire MDx System Leverages Novel Approaches for POC Market

Trinity Biotech, Imaware Strike Lab Testing Services Deal

Lucira Health Files for Chapter 11 Bankruptcy, Signals Intent to Sell Business

Jana Care, Roche Collaborate to Develop POC Blood Tests for Kidney, Heart Disease

Owners of California Mobile Phlebotomy Company Plead Guilty to $7.5M Fraud Scheme

Thermo Fisher Discontinues Cascadion SM Clinical Analyzer

Illumina ordered to divest Grail by FTC on anticompetition concerns

FDA Winding Down COVID, Mpox Test Emergency Use Authorizations

JPM23: 'What has the pandemic done for us?' Freenome and other diagnostics developers on making…

CMS Arbitration Backlog, Fee Hike Add to Labs' Surprise Billing Challenges

Invitae Refinances Debt, Raises $30M as Q4 Revenues Drop 3 Percent

ProPhase Labs Partners With mProbe, Mayo Clinic on Esophageal Cancer Screening Test

Devyser to Distribute Paragon Genomics NGS Target Enrichment Tech in Italy

Natera Q4, Full-Year Revenues Rise on Increased Product Sales, Test Volume

Beckman Coulter Partners with MeMed to Develop, Commercialize Host Immune Response Test

Guardant Health to Integrate Lunit's AI PD-L1 Scoring Algorithm Into Tissue Test Offering

Servier, Qiagen to Develop PCR-Based Companion Diagnostic to Identify IDH1-Mutant Leukemia

Clarapath Acquires Digital Pathology Company Crosscope

UK Cancer Detection Firm CanSense Raises £1.5M for Development of Colorectal Cancer Test

Pramana, PathPresenter to Accelerate Digital Pathology Adoption

Lucira Health Combo Flu/COVID-19 MDx Test Gets Regulatory Approval in Australia

Diagnostics Firm TGV-Dx Aims for Faster, Broader Antibiotic Susceptibility Testing

Cardio Diagnostics Enters Private Financing Agreement for up to $11.2M

BioMérieux, Biocartis, Beckman Coulter Gain FDA 510(k) Clearances in February

BioMérieux's BioFire Defense Wins BARDA Contract to Further Develop Rapid AST System

In Brief This Week: MDxHealth, Biodesix, FIND, Alverno Labs, Ibex Medical Analytics

Guardant Health Submits Colorectal Cancer Screening Test to FDA for Premarket Approval

Renalytix, Partners Launch $10M Consortium to Develop Kidney Disease Drug Response Tests

NYU Langone Perlmutter Cancer Center to Validate Biological Dynamics Pancreatic Cancer Test

In Brief This Week: Fujifilm, BD, PerkinElmer, OpGen, More

SD Biosensor Eyes Global Expansion as Evaluations Find Rapid MDx System on Par With Competition

Arima Genomics to Offer NGS-Based Gene Fusion Test Through Protean BioDiagnostics CLIA Lab

DiaSorin Gets FDA 510(k) for Molecular COVID-19/Flu Assay

Dutch Researchers Craft Glow-in-the-Dark POC Infectious Disease Test

GenoMe Diagnostics Preparing Digital PCR-Based Ovarian Cancer Test for US, EU, UK Submissions

Droplet Biosciences Targets Lymph Fluid in New Residual Cancer Detection Strategy

Autoantibody-Based Alzheimer's Test by Durin Technologies Moving Toward Potential Commercialization

ACMG: Rare Disease Patients in Poor Countries See Benefit from Clinical Whole-Genome Sequencing

Grifols Betting on Free OTC Tests to Expand COPD Diagnoses, Treatment

Australia's Genetic Technologies Seeks Private Payor Coverage to Bring Polygenic Risk Tests to US

Quest Diagnostics Gets FDA Emergency Use Authorization for COVID-19 Sample Collection Kit

Chicago-Area Lab Owner Indicted on COVID-19 Testing Fraud

Warning Possible Insolvency, Chembio Diagnostics Urges Shareholders to Accept Biosynex Acquisition

LumiraDx Q4 Revenues Fall 65 Percent

Invitae, Epic Sign Deal to Integrate Genetic Test Results Into EMR System

Vitestro Raises €12 million in Series A Round

GeneDx Q4 Revenues Grow 6 Percent but Miss Consensus Estimate

ProPhase Labs to Repurchase $6M of Common Stock

TruDiagnostic, Nadmed Partner to Launch Nadmed Metabolite Test in US

Mainz Biomed Partners With Labor Staber to Market ColoAlert Test

Cue Health Q4 Revenues Drop 24 Percent

In Brief This Week: PerkinElmer, Roche, T2 Biosystems, Co-Diagnostics, More

Massachusetts Lab Owner Indicted on Charges of Urine Drug Testing Fraud

Becton Dickinson Gets FDA 510(k) Clearance for High-Throughput Vaginitis Test

Labcorp Acquiring Enzo Biochem's Clinical Lab Business for $146M

Owlstone Medical, Bicycle Therapeutics Ink Research Agreement on Early Cancer Detection

Neogap Therapeutics, Simsen Diagnostics Collaborate on Cancer Dx

Oxford Gene Technology Obtains CE-IVDR Certificates for FISH Products

Virax Biolabs Raises $4M in Private Financing

Agilent, Hamamatsu Ink Digital Pathology Deal

Paige, Leica Biosystems Expand Digital Pathology Partnership

DnaNudge, Mylab Discovery Solutions Forge Dx Partnership for Diabetic Foot Infections

Genomics England Partners With Sectra to Combine Genomics, Digitized Medical Imaging Data

https://event.on24.com/eventRegistration/console/apollox/mainEvent?&eventid=4113307&sessionid=1&username=&partnerref=eblast4&format=fhvideo1&mobile=&flashsupportedmobiledevice=&helpcenter=&key=F738CB3A9D37DFA8AC9B5CEE172C140A&newConsole=true&nxChe=true&newTabCon=true&consoleEarEventConsole=false&text_language_id=en&playerwidth=748&playerheight=526&eventuserid=608664293&contenttype=A&mediametricsessionid=522203751&mediametricid=5801238&usercd=608664293&mode=launch

Visby Medical Point-of-Care STI Test Gets FDA 510(k) Clearance, CLIA Waiver

Six months after launch, Bert Vogelstein's latest blood testing startup gets acquired for $450…

Corista, Qritive Partner to Integrate Digital Pathology Solutions

End of COVID-19 Public Health Emergency Spells Lower Reimbursement, Test Volume for Labs

BioMérieux Sees New Clinical Diagnostic Product Launches Fueling Future Revenue Growth

Blood-Based MRD Testing Identifies AML Patients at Risk of Relapse After Stem Cell Transplant

Abuse Notice

Roche Nabs FDA Approval for Ventana PD-L1 Test as CDx for Libtayo

MGI Tech Gets CE Mark for DNBSeq-G99 Sequencer Under New EU IVDR Framework

Abbott Gains FDA Clearance for Lab-Based TBI Test

AACC Issues New Cervical Cancer Detection Guidance

T2 Biosystems Readies Biothreat Panel for FDA Submission While Keeping Eye on Sepsis Market

Quanterix Q4 Revenues Down 15 Percent

Invitae's PCM Assay for Minimal Residual Disease Detection Nabs Coverage by Blue Shield of…

Fluxergy Acquires InnaMed's Blood Testing Tech to Support Metabolic Panel Development

Large European study underlines power of genomic sequencing to diagnose diseases

BGI Genomics Gets Australian Regulatory Approval for Multiplexed SARS-CoV-2, Influenza Test

FDA Grants Marketing Rights for InBios Point-of-Care Anthrax Test

Siemens Healthineers to Distribute Hamamatsu Whole-Slide Scanners in Americas, Europe

Layoffs at Life Science, Dx Firms Continue as Thermo Fisher Scientific, Natera Shrink Payrolls

Personalis to Lay off up to 30 Percent of Workforce

FDA Grants Emergency Use Authorization for BioSynchronicity COVID Antigen Test

Sophia Genetics Q4 Revenues Grow 23 Percent on Strong Data Analysis Sales

Amoy Diagnostics PLC Panel Gets Approval in Japan as CDx for Retevmo in Non-Small Cell Lung Cancer

VieCure, Exact Sciences Partner to Ease Genomic Testing Access, Interpretation

CareDx Stock Rises Following American Society of Transplant Surgeons' Position Statement on Test…

As Pandemic Wanes, Firms That Rode COVID-19 Testing Wave Struggle for Solid Footing

Northern Ireland-Based Cancer Dx Firm GenoMe Diagnostics Raises £1.4M

BioMérieux Q4 Revenues up 11 Percent

Siemens Healthineers, Sysmex Ink Hemostasis Supply Agreement

Agilent Technologies to Distribute Proscia Digital Pathology Platform

UK NHS Expands Access to Ibex Cancer Diagnostics

Fujirebio, AriBio Partnering on Alzheimer's Biomarker Development

Cota, Genomic Testing Cooperative Ink Precision Oncology Partnership

FDA Grants De Novo Authorization to Sofia 2 System, COVID-19 Antigen Assay

MolDx Reimbursement Decision Likely to Have Negative Impact on CareDx, Natera Transplant Businesses

Exact Sciences to Net $133M in Senior Notes Exchange and Purchase Agreement

Natera's Signatera Gains First Commercial Payor Coverage in California, Louisiana

Point32Health Expands Coverage of Foundation Medicine CDx Tests for Patients With Advanced Cancer

Illumina, Myriad Genetics Expand Partnership to Bring TSO 500 HRD Assay to US

HHS OIG Report Finds Drug Testing Overpayments Cost CMS $216M

Biocartis Nabs FDA 510(k) Clearance for Lynch Syndrome Screening Assay

MedMira, Maternova Sign Distribution Deal for Infectious Disease Tests in US, Latin America

Myriad Genetics Q4 Revenues Rise 11 Percent on Higher Test Volumes

Fulgent Genetics Q4 Revenues Fall 73 Percent, Beat Expectations

Agilent Technologies Fiscal Q1 Revenues Rise 5 Percent

Lucira Health Files for Chapter 11 Bankruptcy, Signals Intent to Sell Business

Castle Biosciences Q4 Revenues Jump 53 Percent as Firm Beats Analyst Expectations

Exact Sciences Q4 Revenues up 17 Percent as Firm Preps Expanded Oncology Portfolio in 2023

Irish Dx Firm Trinity Biotech Enters Increased Term Loan Facility

FDA Issues Emergency Use Authorization for GenBody At-Home COVID Antigen Test

Spectrum Solutions Saliva Collection Device Granted FDA 510(k) Clearance

Mainz Biomed Acquires Colorectal Cancer Testing IP From Uni Targeting Research, Socpra Sciences

Becton Dickinson Onclarity HPV Assay FDA-Cleared for Use With Hologic ThinPrep Pap Test

Lucira Health OTC, At-Home COVID/Flu Test Gets FDA EUA Days After Firm Files for Bankruptcy

Chembio Diagnostics Gets CLIA Waiver for HIV-Syphilis Dual Rapid Test

LexaGene Files for Chapter 7 Bankruptcy

German Researchers Awarded €2M to Develop 'Suprasensors' for Use in Clinical Diagnostics

Veracyte Ramps up Clinical Evidence Generation, Driving Gains in Prostate and Thyroid Test Business

FDA Grants Emergency Use Authorization for Mologic At-Home COVID-19 Antigen Test

Lucence Liquid Biopsy Test to Receive Medicare Reimbursement in Lung Cancer

NeoGenomics Realigns Business Segments to Further Growth Efforts

Synaps Dx Prepares Launch of Skin-Based Alzheimer's Disease Diagnostic Test

C2N Diagnostics Receives $15 Investment from GHR Foundation

India's InDx 2.0 Program Aims to Improve Molecular Testing Capacity for Infectious Diseases

UnitedHealthcare Clamping Down on Expanded Carrier Screening, Genetic Counselors, Testing Firms Say

VolitionRx Prices $7.5M Public Offering

EDX Medical Group to Acquire Torax Biosciences

In Brief This Week: Bluejay Diagnostics, Abbott, Lunit, Chronomics, Analytik Jena, Alercell

National Government Services Expands Coverage for Bio-Techne's ExoDx Prostate Cancer Test

CareDx Q4, Full-Year Revenues Rise on Back of Cash Collections, Test Volumes

Roche Expands Partnership With CDC to Strengthen Lab Systems for HIV, Tuberculosis Testing

In Brief This Week: Abbott, Thermo Fisher Scientific, Danaher, Oncocyte, Biocartis, More

Centogene Regains Compliance With Nasdaq Listing Requirement

Epigenomics Announces Layoffs, Product Line Cancellation in Restructuring

Quest Diagnostics Expands Lab Services for Tower Health

Why the rise of DNA testing is creating challenges - and an opportunity

Rockefeller Foundation Extends Free At-Home COVID-19 Testing Program

Bionano Genomics Obtains China NMPA Approval for DNA Extraction, Labeling Products

Rarity Bioscience Raises Additional €500,000

Becton Dickinson Fiscal Q1 Revenues Down 3 Percent; Firm Raises FY23 Guidance

Hologic Fiscal Q1 Revenues Fall 27 Percent as COVID-19 Assay Sales Continue Slide

Ibex Medical Analytics Nabs CE Mark Under IVDR for Prostate Cancer Detection Software

Adaptive Biotechnologies Lays out Strategy to Drive ClonoSeq Adoption

Medicare to Cover Natera's Signatera MRD Test in Breast Cancer

Sera Prognostics Shares Spike on Positive Study Results for PreTRM Preterm Birth Test

NeoGenomics Eyes Bladder Cancer as Future Indication for Radar MRD Test

Labcorp Sees Uptick in Lab Acquisition Opportunities; Q4 Revenues Down 10 Percent

Bio-Rad Q4 Revenues Flat, Miss Analyst Estimates

QuidelOrtho Focuses on Three Growth Drivers in 2023 as Q4 Non-COVID Business Grows

Epic Systems Planning To Expand Lab-EMR Integration Efforts

MDxHealth Prices $40M Public Offering

Renalytix to Raise $20.3M in Private Placement

Anavasi Gets FDA Emergency Use Authorization for Molecular Point-of-Care COVID-19 Test

Roche, Janssen Expand Companion Diagnostic Collaboration

NICE Recommends Genedrive Test in Draft Guidance to Prevent Hearing Loss in Newborns

Roche Planning 2024 Launch of Automated Mass Spec Clinical Analyzer

Universal DX Eyeing Approval for Colorectal Cancer Early Detection Test After Positive Data

Startup mDetect Readying Trial of Methylation-Based Liquid Biopsy for Breast Cancers

Cedars-Sinai Researchers Leverage Extracellular Vesicles for Prostate Cancer Status Test

Qiagen Beats Q4 Estimates, Guidance; Details Oncology IVD Plans for Digital PCR Platform

Quest Projects 10 Percent Drop in 2023 Revenue But Expects Rise in Base Testing Business

Immunexpress Begins US Commercialization of Near-Patient Sepsis Diagnostic Test

New Liquid Biopsy Data at ASCO Highlights Commercial Push Into Early Cancer Detection

Drug Approvals Spark Interest in Alzheimer's Plasma Markers; Utility, Applications Still Uncertain

UnitedHealthcare Issues New Policy Expanding Coverage of Precision Oncology Diagnostics

UnitedHealthcare to Cover Guardant360 for Approved CDx Indications in Lung, Breast Cancer

In Brief This Week: Meridian Bioscience, Abbott, Danaher, DermTech, More

In Brief This Week:, Bio-Techne, DermTech, Cue Health, DiaSorin, Devyser, More

Becton Dickinson Nabs FDA EUA for COVID-19, Influenza, RSV Test

BioMérieux Point-of-Care System, Respiratory Panel Get FDA 510(k) Clearance, CLIA Waiver

Qiagen's Thierry Bernard named chair of the AdvaMedDx board

Genetic Technologies to Raise A$5M in Direct Stock Offering

Euformatics, ViennaLab, Oncompass Win European Liquid Biopsy Development Contract

Sherlock Biosciences Expects Sense Biodetection Buy to Accelerate Commercialization Plans

DiaSorin Selling Luminex Flow Cytometry Business to Cytek Biosciences for $46.5M

Owkin-led Machine Learning Study IDs Possible Cancer Treatment Biomarkers Using Federated Model

Guardant Health to Study Impact of Shield Blood Test on Colorectal Cancer Screening Compliance

Mainz Biomed Inks Commercialization Deals for Colorectal Cancer Test in UK, Spain

T2 Biosystems Prices $12M Public Offering

Qiagen Gets CE Mark for QuantiFERON-TB Gold Plus Under New EU Framework

PerkinElmer Revenues Drop 28 Percent in Q4 on COVID-19 Test Decline

Tasso Gets CE Mark for At-Home Blood Collection Device

Modell Foundation, Veritas Strike Deal to Test Thousands for Primary Immunodeficiency

OraSure Technologies Restructures Business as Q4 Revenues Nearly Double

Quest Diagnostics to Acquire Parts of NewYork-Presbyterian Lab Business

https://www.360dx.com/business-news/brief-week-meridian-bioscience-barda-hhs-oncocyte-genedx-more?utm_source=Sailthru&utm_medium=email&utm_campaign=360DN%20Fri%202023-02-03&utm_term=360Dx%20Daily%20News#.ZB6OYuzMLdp

Boston University, Cepheid Get FDA EUAs for COVID-19, Monkeypox Tests

Cepheid | GeneXpert Xpress

Cepheid | GeneXpert Infinity

Velsera to Integrate Arima Genomics Gene Fusion Test in Pierian Clinical Platform

CDRH Statement on the Lucira Health's COVID-19 & Flu Home Test

Dxcover Raises $11.9M to Bring Infrared Spectroscopy Cancer Detection Assay to Market

https://www.fiercehealthcare.com/health-tech/precision-medicine-company-tempus-inks-3rd-major-pharma-deal-securing-nearly-1b-revenue

Ampel BioSolutions, Duke Researchers Establish Fibromyalgia Gene Signature

LumiraDx Receives Notice From Nasdaq Over Missed Listing Requirement

Bio-Techne Fiscal Q2 Revenues Inch up as Protein Business Lags but Genomics Boom

Thermo Fisher Scientific Clinical Research Business Delivers Strong Results in First Full Year

Sherlock Biosciences to Acquire Sense Biodetection

Biogenes Technologies Raises $5.7M in Series A Round

FDA issues rare comment on approval of Covid and flu home test from company that went bankrupt

Startup RT MicroDx Aiming to Disrupt OTC Space with Disposable Strep Spit MDx

FDA Updates 510(k) Clearances for Becton Dickinson, Roche, BioMérieux in January

Clickmer Systems, Fraunhofer IMS Win €1.1M Grant to Develop Diagnostic Platform

FIND, Indonesia Partner on Diagnostic Testing Access Initiative

LumiraDx Secures FDA Emergency Use Authorization, UK Approval for COVID-19, Flu Test

Roche Diagnostics Revenues Essentially Flat in 2022

Abingdon Health to Distribute Salignostics' Pregnancy Test in UK, Ireland

Simple HealthKit Raises $8M in Series A Round

Quest Projects 10 Percent Drop in 2023 Revenue But Expects Rise in Base Testing Business

Siemens Healthineers Q1 Dx Revenues Fall 21 Percent; Firm Strikes Lab Analyzer Deal With Unilabs

Unilabs, Ambry Genetics Partner to Market Research-Use Genomic Testing Services Internationally

Lucira Health

FDA Issues Emergency Use Authorization to Lucira Health OTC At-Home Test for COVID-19/Flu

The FDA has cleared the first home flu and Covid test - but its maker just declared bankruptcy

In Brief This Week:, Thermo Fisher Scientific, Agilent, Labcorp, More

FDA Grants EUA for Scope Molecular Laboratory SARS-CoV-2 Test for Serial Testing

Hera Biotech Aims to Diagnose Endometriosis With Single-Cell Targeted Gene Expression Panel

New Study Results Boost Evidence for Natera's MRD Assays to Guide Adjuvant Therapy Decisions

Geneoscopy Submits PMA Application to FDA for Stool-Based Colorectal Cancer Screening Test

DermTech Stock Soars on News of Additional Coverage for Melanoma Detection Test

Researchers Validate Rapid Molecular Kaposi's Sarcoma Assay in Uganda

Blu Biotech Sniffing Out Infections, Cancer With Multi-Disease Breathalyzer

Abbott Q4 Diagnostics Revenues Fall 26 Percent on Declining COVID-19 Sales

Geneseeq Nabs CE Marks for Residual Disease and Cancer Early Detection Tests

Vésale Bioscience Receives €1.8M to Develop Phage Therapy Diagnostic Platform

Guardant Health Lays off 7 Percent of Workforce

PamGene, Alithea Genomics, Lausanne University get €1M for Pan-Cancer Blood Test

FDA Authorizes First Over-the-Counter At-Home Test to Detect Both Influenza and COVID-19 Viruses

JP Morgan Healthcare Conference, Day 3: Invitae, Bio-Rad, Bio-Techne, Opko

Evolving Akoya Biosciences Touts CDx Partnerships at JP Morgan Conference

Caris Life Sciences Taps Juniper Biologics to Market Sequencing Tests in Southeast Asia

Immunovia Reducing Headcount, Realigning to Focus on Pancreatic Cancer Test Commercialization

In Brief This Week: Biocartis, Quest Diagnostics, OpGen, More

Quest Diagnostics to Offer Agilent Companion Test for Mirati Therapeutics NSCLC Treatment

Colorectal Cancer Detection Data from CellMax Life Bodes Well for Planned FDA Bid

Invitae Bets on Oncology Portfolio to Drive Growth as it Streamlines, Integrates Test Services

Danaher Q4 Revenues Rise 3 Percent Despite Difficulties in China

Thermo Fisher Scientific, AstraZeneca to Develop Solid Tissue and Blood-Based CDx Test

UK IVD Industry Hindered by Lack of Funding, Structural Issues, Report Says

Quest Diagnostics Addresses Acquisitions, Reimbursements, Testing Landscape at JP Morgan

Press Releases - Chembio Diagnostics, Inc.

Scripps Research, Cue Health Pair up for COVID Test-to-Treat Program for Immunocompromised

DiaCarta Nabs FDA Emergency Use Authorization for Monkeypox Test

Pathology Firm Paige Gets Microsoft Investment for Cloud-Based AI Dx

MedMira Gets CE Mark for COVID, Flu Combo Assay

Co-Owner of Defunct Clinical Lab Sentenced to Two Years in Prison for Kickback Scheme

Caris Life Sciences Raises $400M in Senior Secured Debt Financing

Atomo, NG Biotech Partner on Blood-Based Pregnancy Test

Freenome Partners With Geisinger to Recruit Patients for Multi-Cancer Screening Study

Lucid Diagnostics Lays Off 20 Percent of Workforce in Business Reprioritization

Selux Diagnostics Next Generation Phenotyping System Gets FDA 510(k) Clearance

Guardant Health, Royal Marsden Partner on Prospective Liquid Biopsy Trial in Early Colorectal…

Foundation Medicine, Boehringer Ingelheim Collaborate on CDx for Biliary Tract Cancer Drug

Rebranded GeneDx Bets Future on Whole-Exome, Whole-Genome Sequencing in Pediatric Rare Disease

Linus Biotechnology Raises $16M in Series A Funding

Quanterix Restructuring Efforts on Track, CEO Says at JP Morgan Conference

SomaLogic Seeks 'Strategic Alternatives' for Dx Business to Focus on Life Science Market

ARUP, University of Utah Building Lab Training Center With $3M in Federal Funds

Genetron Regains Compliance With Nasdaq Listing Requirement

Lucence Liquid Biopsy Test to Receive Medicare Reimbursement in Lung Cancer

AnPac Bio Receives Nasdaq Delisting Notice

Lucira Health Shares Down 33% on Chapter 11 Filing

https://www.bloomberg.com/news/articles/2023-02-22/covid-test-maker-lucira-goes-bankrupt-as-demand-for-kits-wanes#xj4y7vzkg

Prenetics' ACT Genomics Profiling Test for Solid Tumors Receives FDA Clearance

JP Morgan Healthcare Conference, Day 2: Labcorp, Abbott, Thermo Fisher Scientific, Roche, More

PerkinElmer Becoming Pure Play Dx, Life Science Firm, Spurred on by COVID Innovations

BD Receives FDA Emergency Use Authorization for COVID-19, Influenza A/B, RSV Combination Test

Sema4 Changes Name to GeneDx, Provides Preliminary 2022 Revenues, 2023 Guidance

Myriad Genetics Highlights 2023 Product Launches for Women's Health, Oncology Businesses

NIH Funds Eight Studies of Pediatric COVID-19 Inflammatory Syndrome

Doctor-Reviewed At-Home Health Testing | imaware

DOJ Indicts Lab Owners in Alleged Conspiracy to Fraudulently Bill Medicare $107M

Proove Biosciences CEO Exonerated in PGx Test Kickback Case

Foundation Medicine, Karyopharm Therapeutics Partnering on Endometrial Cancer CDx

Sophia Genetics to Commercialize MSK-ACCESS Clinical Liquid Biopsy Test

Tasso High-Volume Liquid Blood Collection Device Earns CE Mark Certification - Tasso, Inc.

MDx Firm OpGen Prices $7.5M Public Offering

Hologic Aims to Expand Global Reach With Focus on Women's Health

Natera Eyes Regulatory Path for Signatera as Companion Diagnostic

Guardant Health Lays off 7 Percent of Workforce

ClearNote Health Furthers Commercialization Prospects for Pancreatic, Ovarian Cancer Tests

Lucira Health, Sesame Partner on COVID-19 Test-to-Treat Program

Anavasi Diagnostics Receives FDA Emergency Use Authorization for The AscencioDx COVID-19 Test and…

MIT Spinout C2Sense Raises $8M in Second Closing of Series B

FDA Approves Foundation Medicine Blood Test as CDx for Rozlytrek

Agilent, Akoya to Commercialize Workflow Tools for Tissue Biomarker Analysis

FDA Warns Empowered Diagnostics About Unauthorized COVID-19 Tests

COVID-19 Still a Focus for Infectious Disease Test Developers in 2022, but Ceded Some Ground

Aided by COVID-19 Funding, Firms Continued Developing Handheld Diagnostic Instruments in 2022

Israeli Startup JaxBio Snags €8.5M EU Grant to Support Creation of Array-Based Cancer Tests

Macroeconomic Concerns, Declining COVID-19 Interest Lead to Less Dx M&A Activity in 2022

HHS OIG Report Finds Medicare Spending on Lab Tests Increased 17 Percent in 2021

Siemens Healthineers, Roche, Beckman Coulter, Abbott Gain FDA 510(k) Clearances in December

Roche Gains IVDR Certificate for Cancer Treatment Companion Dx

In Brief This Week: Thermo Fisher Scientific, Burning Rock, DermTech, More

Biocept to Lay Off 35 Percent of Staff, Explore Strategic Alternatives

Qiagen, Helix Partner for Hereditary Disease CDx Development

NIH Launches COVID-19 Home Test to Treat Telehealth Program

Precision BioLogic Nabs FDA 510(k) Clearance for Factor IX Deficiency

Japan Approves Sysmex Assays for Alzheimer's Disease

In Brief This Week: SomaLogic, Centogene, Yourgene, Epigenomics, Biodesix, More

Sema4 Receives Nasdaq Noncompliance Warning, Will Return $42M Under Payor Lawsuit Settlement

Prostatype Genomics, Life Genomics Ink Commercialization Deal for Prostate Cancer Test

Why Personalis Shares Are Trading Higher Today

Vero Biotech raises $30M for tankless nitric oxide delivery system - TMG Pulse

Digital health unicorn Innovaccer lays off 245 employees

https://www.fiercebiotech.com/medtech/jpm23-illumina-could-face-eus-maximum-fine-jumping-gun-grail-deal-report

Invitae Sells Archer NGS Research Assays to Integrated DNA Technologies for $48M

Natera Files Second Patent Infringement Suit Against NeoGenomics Subsidiary Inivata

QuidelOrtho, Access Bio, iHealth, Orasure Nab DoD Contract for COVID-19 Antigen Tests

European IVD Makers Continued to Face Regulatory Uncertainty Around IVDR, Brexit in 2022

Public, Private Dx Financing Wanes as Post-Pandemic Diagnostics Landscape Changes

Virax Biolabs Preparing T-Cell Testing Platform to Provide Consumers With Immune Status Info

NeoGenomics Growing Evidence Base for Residual Disease Assay in Breast Cancer

HHS Launches New Program to Speed Up COVID-19 OTC Test Regulatory Process

White House COVID Dx Goals Potentially Feasible but More Funding, Coordination Needed, Experts Say

KU Leuven-led Project Aims to Develop Mass PCR Testing Platform for Future Pandemics

Molecular SMA Testing in Newborns on the Rise as Countries Add Screening Programs

Three years pilot of spinal muscular atrophy newborn screening turned into official program in…

New Guidance Related to IVDR Issued Covering High Risk IVDs

New Guidance Related to IVDR Issued Covering High Risk IVDs

Labs Contend With Ongoing Trends in 2022 as Major Legislative Efforts Fizzle

Visby Medical Nabs FDA EUA for POC Respiratory Panel Test

FDA Issues EUAs for OTC, At-Home COVID-19 Antigen Tests From Advin Biotech, Oceanit Foundry

Becton Dickinson Monkeypox PCR Assay Granted FDA Emergency Use Authorization

Guardant Health, Susan G. Komen Partner to Evaluate MRD Test in Breast Cancer

Japanese Lung Cancer Genomic Screening Project Expands in Asia-Pacific

CTK Biotech Gets FDA Emergency Use Authorization for At-Home COVID Antigen Test

FDA Grants EUAs to Lucira Health Molecular COVID/Flu Test; Azure Biotech, CorDx COVID Antigen Tests

BioMérieux Gets CE Mark for Next-Gen Immunoassay System

Gene Signature Reflects Host Response to COVID-19 Infections With Low Cross-Reactivity

FDA Grants Emergency Use Authorization for OnsiteGene Molecular COVID-19 Test

FDA Approves Foundation Medicine Assay as CDx for Certain NSCLC Therapies

Accelerate Diagnostics Seeks FDA 510(k) Clearance for Expanded Abx Susceptibility Tests

Numares Health Gets €40M Financing from European Investment Bank, Existing Investors

Quidel Triage MeterPro | Quidel

FDA Updates Xeloda Labeling to Make DPYD Variant Risks More Explicit

Form Success | Thermo Fisher Scientific - US

QuidelOrtho Gets Canadian Approval for Point-of-Care High-Sensitivity Troponin Test

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Quality Management System (QMS), Regulations, Cybersecurity, Standards,

Waived Tests

Individualized Quality Control Plan (IQCP)

CLIA 101: Answers to your most common questions about CLIA waived tests

Updating the NIST Cybersecurity Framework - Journey To CSF 2.0

ISO/IEC 27035-1:2023

IEC 80001-1:2021

ISO/TR 80001-2-7:2015

ISO/IEC 29147:2018

ISO/IEC 30111:2019

ISO/IEC 5962:2021

UL 2900-1 Ed. 1-2017

UL 2900-2-1 Ed. 1-2017

ISO/IEC 27035-1:2023

ISO/IEC 27035-2:2023

IEC/TR 80001-2-2:2012

IEC/TR 80001-2-8:2016

ISO/IEC 19770-2:2015

AUTO16: Next-Generation In Vitro Diagnostic Interface

Home - IVD Industry Connectivity Consortium

LAW - Laboratory Analytical Workflow Profile - IVD Industry Connectivity Consortium

MedCon: Shuren updates on EUA transition, TAP, CDRH workforce

Medivance Instruments Ltd. - 647562 - 02/13/2023

The Next Generation of Software Validation: Self Validating Software

ANSI/NEMA HN 1-2019

ISO/IEC 23643:2020

ISO/IEC 2382:2015

ISO 17090-4:2020

ISO/IEC/IEEE 14764:2022

ISO/IEC/IEEE 26511:2018

ISO 10303-1:2021

ISO 81001-1:2021

FDA Resumes Move to Regulate LDTs, Likely Setting up Legal Battle With Lab Industry

Principles and Practices for Software Bill of Materials for Medical Device Cybersecurity

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Olympus Medical Systems Corp. - 654013 - 03/15/2023

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IEC 80369-5:2016

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Wintech Medipro LLC - 640048 - 11/16/2022

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Biomedical Research,

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Malaria in pregnancy (MiP) studies assessing the clinical performance of highly sensitive rapid…

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Lung cancer screening

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Cisplatin with veliparib or placebo in metastatic triple-negative breast cancer and BRCA…

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Molecular basis of normal and pathological puberty: from basic mechanisms to clinical implications

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List of sequence alignment software - Wikipedia

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CVS Health debuts new virtual primary care

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Abbott faces Class I recall of 4.2M glucose readers on battery fire risks

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Johnson & Johnson layoffs hit medtech business, with more than 350 cuts in California

Medtech companies start 2023 on 'optimistic' note amid earnings forecasts, staffing: J.P. Morgan

Basecamp Vascular announces upcoming appointment of new CEO - TMG Pulse

Realize Medical wins FDA clearance for VR-based surgical planning software - TMG Pulse

The Pursuit of Digital Solutions in Device - TMG Pulse

Inari Medical enrolls first patient in ClotTriever system trial for treating deep vein thrombosis …

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Novartis data set up multibillion-dollar battle over breast cancer drugs

Amgen to cut 450 jobs in second round of layoffs this year

FDA approves first treatment for Rett syndrome, a genetic neurological disease

Pfizer to buy Seagen in $43B cancer drug deal

Blockbuster drug Humira has new competition. Here's why that matters

Moderna draws more lawmaker criticism for COVID vaccine pricing plan

U.S. Senator Warren 'particularly concerned' about Amgen, Indivior deals

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Magenta halts study of targeted conditioning drug after participant's death

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J&J, Legend's cancer cell therapy has early success in key clinical trial

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Bristol Myers says CAR-T therapy curbed leukemia in long-running study

US regulator stays firm on knockbacks

Two decades and $200 billion: AbbVie's Humira monopoly nears its end

Merck gets a 'surprise' win for Keytruda in early lung cancer

FDA advisers back agency plan to simplify COVID-19 vaccination

Celularity warns of layoffs for 'substantial portion' of its staff

FDA Approves Tucatinib Plus Trastuzumab for RAS Wild-type, HER2+ Metastatic Colorectal Cancer

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Public Health, Global Health,

CDC Director Rochelle Walensky to step down

The natural history of untreated pulmonary tuberculosis in adults: a systematic review and…

Tanzania reports a Marburg outbreak, Africa's second this year

MakeMyTestCount: Report COVID-19 home test results safely and privately.

What's next for COVID-19 vaccines? Scientists and regulators chart a course amid uncertainty

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Entrepreneurship,

Liquid Biopsy Thought Leaders: Dr. Howard Scher, MSK - BLOODPAC

Pop Goes the Digital Health Bubble

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