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1 Visby Medical's COVID-19 PCR Point of Care Test Authorized for Use in CLIA Waived Settings
2 binx health Enters into Distribution Agreement for National Launch of the FDA-cleared binx io
3 University in-house TASC Lab begins COVID-19 diagnostic testing
4 Reditus Laboratories achieves CAP accreditation; perfect score
5 US BioTek Laboratories Announces At-Home COVID-19 Test
6 FDA issues mea culpa for early COVID-19 serology test nods | Medical Design and Outsourcing
7 Labs can't tell you if you have a COVID variant, a problem for tracking and prevention
8 Verici Dx accelerates commercial launch
9 CMS Streamlines CLIA’s Clinical Lab Certification Process for COVID-19 Testing
10 CMS Streamlines CLIA Certification to Expand COVID-19 Testing
11 Have a case of Covid variant? No one is going to tell you
12 The Laboratory Developed Test Market to witness 2.5X growth in the next decade
13 Guam Regional Medical City to offer one-stop radiology center starting in March
14 Without a Waiver, Nursing Homes Won't Receive Point-of-Care Testing Units Under New Federal Push
15 Have a COVID-19 Variant? No One Is Going to Tell You
16 Highland Park, Deerfield high schools to enforce COVID-19 testing program
17 Testing a new COVID-19 test: How T-cells beat antibodies in helping to detect past infections
18 Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices
19 CMS Regulatory Flexibility for CLIA Laboratories
20 Reference Labs Take Diverse Approaches to Mitigating COVID-19 Sample Shipping Delays
21 Tissue Processing Systems Market to Reach US$ 493.76 Million by 2027- The Insight Partners
22 FDA admits COVID-19 antibody test policy was 'flawed,' offers lessons for future outbreaks
23 Natera to Participate in the Cowen 41st Annual Health Care Conference
24 CMS Announces New CLIA Waived Tests And Their CPT Codes
25 CMS Offers Guidance On Expedited CLIA Certification | Faegre Drinker Biddle & Reath LLP
26 Editorial: U.S. FDA’s Experience with COVID-19 Antibody Tests
27 CDRH officials dissect early-pandemic test guidance missteps
28 CMS to expedite review of CLIA waivers for COVID-19 point-of-care tests
29 The FDA's Experience with Covid-19 Antibody Tests | NEJM
30 Detecting Alzheimer's Gets Easier with a Simple Blood Test
31 Up to the Test
32 FDA issues EUA for Thermo Fisher Scientific COVID-19, flu combo test
33 Natera Reports Fourth Quarter and Year 2020 Financial Results
34 CRISPR-Based Testing Feasible for SARS-CoV-2 Screening
35 Adaptive Biotech revenue up 25%; company launches T-cell test for past COVID-19 infections
36 Governor of California Signs Executive Order Permitting Pharmacists, Pharmacy Technicians to Conduct CLIA-waived COVID-19 Tests
37 UCSB Expands COVID-19 Testing With CLIA-Certified On-Campus Diagnostic Laboratory
38 Applying For or Updating a CLIA Waiver During The Pandemic
39 Applied DNA to Provide Back-To-Campus COVID-19 Surveillance Testing to LIM College
40 CIRION and Providence Therapeutics Collaborate to Support COVID-19 Clinical Research
41 COVID-19 and Clinical Laboratories: Licensing Requirements For Diagnostic Testing
42 Supply shortages negatively impacting not only Covid-19 testing
43 Sorrento Receives Licensure From the State of California for Clinical Testing Laboratory (CLIA) Allowing for Clinical Sample Testing
44 Point-of-care testing helps dry eye diagnosis
45 Natera and Personalis Partner for Personalized Monitoring in Oncology
46 CMS provides guide to streamline process to receive COVID-19 test kits
47 Racing Against COVID-19 | The UCSB Current
48 bioMérieux – 2020 Financial Results
49 PCH clinical laboratory earns accreditation
50 Regulators urge yanking lab's certification
51 Lucence Receives CLIA Certification for US Laboratory, Expands Access to Amplicon-Based Liquid Biopsy Tests
52 Clemson Continues to Lead on COVID-19 Testing, Expands Saliva-Based Capacity
53 Point of Care Diagnostics Market to Record Sturdy Growth by 2023 – The Bisouv Network
54 IgM/IgG Rapid Test Kits Market– A comprehensive study by Key Players: Cellex, RayBiotech, Biopanda – The Bisouv Network
55 Bioinformatics Services Market | Know the Latest Innovations and Future Market Scope
56 Point of Care Testing Market (POCT) – Industry Analysis and Upcoming Trends (2019-2025) | Roche Diagnostics, Becton, Dickinson and Company, Abbott Laboratories, Inc., Biomérieux SA, Bio-Rad Laboratories, Inc., Danaher Corporation, Johnson & Johnson
57 Antibody response and 'original antigenic sin' in RSV influence vaccine development
58 CMS sets user fee increase for CLIA-certified labs
59 ProPhase Labs Completes Acquisition of CLIA Accredited Lab and Provides Corporate Update
60 FDA Finalizes Guidances on CLIA Waiver Applications, 510(k) Dual Submissions
61 Could Labs That Test Livestock Ease COVID Testing Backlog for People? Well … Maybe.
62 Siemens Healthineers offers lab-based antigen test for high-throughput analyzers and expands Covid-19 test capacities
63 Micronoma Raises $3.5 Million in Convertible Note Financing
64 George Mason University Providing COVID-19 Testing with Saliva-Based Advanta Dx SARS-CoV-2 RT-PCR Assay on Biomark HD Platform
65 In Vitro Diagnostic Tests: FDA Finalizes Lab Guidance Documents
66 CDC gives new pathway for point-of-care reporting on NHSN site
67 Virus Puts Spotlight on Remote Pathology – InsideSources
68 CMS Increases CLIA Certification Fees By 20% Effective Immediately
69 Boise State's first clinical lab helps the university test for COVID-19
70 Proteus Nucleic Acid Detection Kit Market 2021 Business Outlook – BioGerm, Bioperfectus, Kinghawk – KSU | The Sentinel Newspaper
71 Thinking of Using Serology Testing for COVID-19? Don’t Overlook CLIA Certification Rules
72 Labs scramble after FDA loosens regulations on some tests
73 Princeton University will open COVID-19 testing laboratory for campus community
74 Administrative Notice Limits the FDA's Ability to Regulate Laboratory Developed Tests, Including COVID-19 Tests
75 Federal Advisory Committee Seeks Public Comments on Revising CLIA Regulations, says Keynote Speaker at 13th Annual Lab Quality Confab in Atlanta
76 Pharmacy Times – Point-of-Care Testing
77 CLIA Vs QSR What You Don't Know Can Hurt You
78 Recommendations for Dual 510(k) and CLIA Waiver by Application Studies
79 AnPac Bio Philadelphia Lab Gains U.S. CLIA Lab Certification
80 CMS Releases List of First Nursing Homes to Receive Devices Under COVID-19 Testing Initiative
81 Macrogen Becomes the First Clinical Lab in Korea to Receive CLIA Accreditation
82 5 Things to Know about Traveling to Jamaica With New COVID-19 Restrictions
83 FlowMetric Life Sciences, Inc. Receives CLIA High Complexity Laboratory Certification
84 PDF that blocks study volunteers from getting their data must go
85 Lab Fees to Increase 20 Percent to Continue Funding CLIA
86 Deadly Delay: The FDA's Role in America's COVID-Testing Debacle
87 FDA issues expanded testing policy for novel coronavirus to address public health emergency
88 HHS ends EUA requirement for Laboratory Developed Tests; FDA may continue to assert authority
89 News Flash: HHS Issues Statement Removing Premarket Review Requirements for Laboratory Developed Tests (“LDTs”), Including COVID-19 LDTs
90 FDA Oversight of Laboratory-Developed Tests Continues To Evolve
91 ProPhase Labs Announces Definitive Agreement to Acquire CLIA Accredited Lab Certified for COVID-19 and Upper Respiratory Testing
92 Co-Diagnostics, Inc. Enters into Agreement with Arches Research to Expand COVID-19 Testing Services
93 Clemson to offer free COVID-19 testing to community
94 Potawatomi Support Services now offers a rapid and comprehensive turnkey surveillance and screening solution for COVID-19 testing
95 SG Blocks Partners With Clarity Diagnostics for US Test Labs
96 How to get approval for fast COVID-19 testing in your dental practice
97 Caprion Biosciences Receives College of American Pathologists (CAP) Accreditation & Clinical Laboratory Improvement Amendments (CLIA) Certification
98 FDA offers more study options for CLIA waivers in redrafted guidances
99 Could COVID-19 end standoff on tests developed in laboratories?
100 CAP Releases 2020 Edition of Laboratory Accreditation Program Checklists Used for Inspection of Medical Laboratories