Free COVID-19 STAT Intelligence Briefings Email Digest

COVID-19 Business Intelligence and Analysis for Clinical Laboratories, Pathology Groups and Hospital Administration

Free COVID-19 STAT Intelligence Briefings Email Digest

Reliable COVID-19 Business Intelligence and analysis for clinical laboratories, pathology groups and Laboratory Diagnostics.

Briefings

Actionable Analysis News and Intelligence From Interviews with Leading Nationwide Experts

COVID-19 Causes Genetic Changes that Create Long-Haul COVID-19 Symptoms, Researchers Find

May 11, 2021 No Comments

What Texas researchers found that changed baseline gene expression in airway cells.

Six-Foot Rule for Preventing the Spread of COVID-19 is Likely Useless, MIT Researchers Find

May 4, 2021 No Comments

Ultimately this research shows that the 6-foot rule should not be a core component of COVID-19 spread mitigation strategies, says MIT professor.

Long-Haul COVID-19 Emerges as a Concern, Potentially Increasing Need for More COVID-19 Antibody Testing

April 26, 2021 No Comments

Clinical laboratories would test for COVID-19 antibodies in those with long-haul COVID-19 symptoms but are unsure if they were ever infected with SARS-CoV-2.

Nationwide COVID-19 Testing Program in Slovakia Proves the Effectiveness of a National Testing Program

April 20, 2021 No Comments

The recent research on Slovakia’s national testing program provides a potential model for containing infectious disease outbreaks.

Clinical Laboratories Should Anticipate Gender-Dependent Differences in COVID-19 Antibody Levels, New Study Suggests

April 13, 2021 No Comments

Clinical laboratories should be aware of the potential for quantitative differences in COVID-19 antibody levels, as demand for antibody testing may increase.

Vaccine Breakthrough Provides Process That Produces $1 Vaccines in Less Than Three Weeks of Development

April 5, 2021 No Comments

As new vaccine breakthrough research continues, Virginia Tech and UVA virologists develop innovative COVID-19 vaccine production platform.

Image of UK B.1.1.7 variant SARS-CoV-2 virus particles (green), isolated from a patient sample

New Assay Allows for Customizable Testing of SARS-CoV-2 Variants Using PCR Technology

April 2, 2021 No Comments

The emergence of multiple SARS-CoV-2 variants brings fast-moving questions for clinical laboratory administrators about the ability to identify these new variants. A new mutation panel may offer an alternative to viral genome sequencing for indicating the possible presence of these variants.

COVID-19 Test Results May Vary Based on Time of Day Specimens Were Collected, New Study Shows

March 23, 2021 No Comments

The new research indicating a time-dependent result for COVID-19 testing may have significant implications for the clinical laboratories.

Research Shows That Decoys Can be Effective in Neutralizing SARS-CoV-2

March 15, 2021 No Comments

Use of this technology could be preventive, administered to people before they have an infection, says Rensselaer professor.

Revenue Experts Give Insights Into How Clinical Laboratories Should Plan for the Future

March 10, 2021 No Comments

A sustained drop in COVID-19 diagnostic testing could present the clinical laboratory industry with opportunities, but it could also lead to potential damages if not handled proactively and correctly.

time running out for COVID-19 test stockpile in Hawaii

Over $23 Million of COVID-19 Tests May Go to Waste in Hawaii as Large Volumes of Tests are Set to Expire

March 1, 2021 No Comments

How the state plans to address potential waste of COVID-19 tests.

First Study to Ever Deliberately Infect Humans With SARS-CoV-2 Set to Provide Valuable Information About Viral Load

February 22, 2021 No Comments

This new SARS-CoV-2 study carries risks and controversy.

New Research Identifies Which Point-of-Care COVID-19 Tests Meet WHO’s Target Product Profiles

February 17, 2021 No Comments

Findings of new research that focuses on the performance of rapid COVID-19 antigen and antibody tests.

August 2020 interview with Bert Lopansri, MD, on scaling up the lab

Lessons One Clinical Laboratory Has Learned as It Passes Its One Millionth COVID-19 Test

February 15, 2021 No Comments

Intermountain Healthcare Laboratories credit “adaptiveness” to achieving COVID-19 test milestone.

Concept of viral genome. Genomics experts learning from sequencing SARS-CoV-2

Dartmouth Researcher Discusses Implications New SARS-CoV-2 Variants Will Have on Clinical Laboratories

February 10, 2021 No Comments

Joel Lefferts, PhD, of the Geisel School of Medicine at Dartmouth explains three major impacts that SARS-CoV-2 variants may have on testing in clinical laboratories.

Models forming toward at-home testing for COVID-19.

DOD Awards Over $230 Million to Increase Availability of Over-the-Counter, At-Home COVID-19 Test

February 2, 2021 No Comments

With fast, affordable, easy-to-use home testing evidently a top priority, the incoming administration continues to adjust national response to the pandemic.

CDC Releases In-Depth Analysis of Abbott SARS-CoV-2 Antigen Test’s Utility Compared to PCR Testing

January 27, 2021 No Comments

Findings of a new study published in the CDC’s Morbidity and Mortality Weekly Report (MMWR) that focused on the performance and public utility of Abbott BinaxNOW SARS-CoV-2 antigen test.

University Develops Successful COVID-19 LDT in Six Weeks by Focusing on the Benefits of Saliva Test

January 25, 2021 No Comments

Insights into University of Illinois’ COVID-19 testing program using saliva test offer perspective on COVID-19 testing for universities.

Viral Load Can Predict COVID-19 Severity Only in Saliva Specimens, New Study Shows

January 18, 2021 No Comments

Summary of new research into viral load with SARS-CoV-2.

national-testing-strategy-SARS-CoV-2-coalition

HHS Announces $22 Billion for COVID-19 Testing and Monitoring

January 11, 2021 No Comments

HHS details state-level support for COVID-19 testing and monitoring, with the more than $19 billion to be allocated through the existing CDC ELC cooperative agreement.

One Clinical Laboratory Now Offering Its COVID-19 Diagnostic Test On Amazon

January 11, 2021 No Comments

While diagnostic testing for COVID-19 slowly shifts away from clinical laboratories, these changes can be beneficial.

Two COVID-19 Testing Trends for Clinical Laboratories to Consider as New Year Begins

January 4, 2021 No Comments

Two key trends are explained as potential opportunities for clinical laboratories in the year ahead.

look at transparency in pricing COVID-19 testing, clinical laboratories

2020 in Review: Three Changes and Trends in COVID-19 Testing That Impacted Clinical Laboratories

January 4, 2021 No Comments

How SARS-CoV-2 (COVID-19) testing evolved from diagnostic testing only in clinical laboratories to three categories of primary diagnostic and secondary testing.

Innovations of 2020: A Look Back at Key Innovations That Were Developed During the COVID-19 Pandemic

December 28, 2020 No Comments

The scientific community starred in the development of several innovations designed to overcome the healthcare challenges brought on by the COVID-19 pandemic.

face shape and face mask use during pandemic and beyond

New Study Searches for a Better Face Mask by Examining How Face Shape Affects Fit

December 21, 2020 No Comments

While face masks are thought to play an important role in mitigating the epidemiological risks of COVID-19, new research aims to understand how well various types of cloth masks and even “nonmedical” surgical masks work.

New EUA Makes COVID-19 Testing Available for Patients Without Clinical Laboratories Playing a Role

December 21, 2020 No Comments

First EUA for at-home and over-the-counter COVID-19 testing removes the need for clinical laboratories to perform COVID-19 diagnostic testing.

Clinical Laboratories May See Unexpectedly Low Number of Influenza Cases This Flu Season

December 17, 2020 No Comments

Week-by-week flu surveillance data show influenza testing in clinical laboratories compared to public health laboratories. While flu cases may be down, testing appears up.

calculator concept covid19 testing calculator

NIH Research Program Leads to Creation of Online Calculator for Determining the Costs of Organizational COVID-19 Testing

December 14, 2020 No Comments

The COVID-19 testing calculator tool developed by NIBIB is a mathematical model-based calculator that produces customized scenarios for COVID-19 surveillance testing.

FDA Issues EUA for First-Ever Direct-to-Consumer COVID-19 Test, Moving COVID-19 Further From Clinical Laboratories

December 14, 2020 No Comments

While the availability of a nonprescription, at-home COVID-19 test collection kit will certainly increase the ease with which testing can be obtained, this new EUA seems to benefit LabCorp exclusively.

Recent Study Concludes That No Routine Clinical Laboratory Test Reliably Serves as a Biomarker for COVID-19

December 9, 2020 No Comments

More on a recent study of 67 routine clinical laboratory tests that sought to identify COVID-19 biomarkers.

Fibrinogen testing as a COVID-19 followup, clinical laboratories

University of Michigan Team Delivers Insights Into Hypercoagulopathy With COVID-19

December 7, 2020 No Comments

The cause of hypercoagulopathy with COVID-19 may be due to autoantibodies, new study shows, creating potential for increased demand for autoantibody testing.

accessioning COVID-29 samples in the lab

CDC Guidelines Include Laboratory Professionals Among First in Line to Receive COVID-19 Vaccine Once Authorized

December 6, 2020 No Comments

The CDC’s Advisory Committee on Immunization Practices met Dec. 3, 2020, to determine COVID-19 vaccine allocation. Clinical laboratories may be among first to receive.

At-Home COVID-19 Testing Finally Arrives: Laboratory Expert Weighs in on the Implications for Clinical Laboratories

December 3, 2020 No Comments

How at-home COVID-19 testing now authorized under FDA emergency use authorization and new tests coming to market may affect clinical laboratories.

More Confusion on Laboratory Developed Tests as HHS Directs FDA to Resume Reviewing LDT EUAs

December 2, 2020 No Comments

New guidance positions FDA and now the NCI in process for those opting to use LDTs in their laboratories with or without FDA premarket review or authorization.

HHS Launches Pilot Program Examining the Use of Integrating Rapid Molecular COVID-19 Test Into Existing Testing Strategies

November 30, 2020 No Comments

HHS Cue pilot program creates hybrid COVID-19 testing strategy, potentially fast tracks Cue into institutions and communities outside of five-state rollout.

Mass nursing home testing begins in hotspots after HHS device distribution

Clinical Laboratories May Benefit as Some Nursing Homes Hesitate to Implement Point of Care COVID-19 Antigen Testing

November 30, 2020 No Comments

Nov. 2, 2020, marks the third and final wave of rapid COVID-19 testing device distribution (to about 1,360 nursing homes), according to CMS. Chilly nursing home response may create opportunities for clinical labs.

EMR covid 19 research into virus timeline

New Tool by Cleveland Clinic and Epic Can Predict Which Patients Are Likely to Test Positive for COVID-19

November 21, 2020 No Comments

Predictive tool for COVID-19 highlights the advantages of coupling machine learning with laboratory data.

Airlines are offering COVID-19 testing for travelers

With COVID-19 Testing Needed for Travel, Fake Negative COVID-19 Tests Emerge as a Problem

November 21, 2020 No Comments

How clinical laboratories can respond to a black market for fake negative COVID-19 test results.

Lessons Learned from New York City COVID-19 Contact Tracing Program

November 18, 2020 No Comments

Three strategies that benefited the community’s contact tracing program.

Special Report Answers Numerous Questions About Developing a COVID-19 Employee Testing Program

November 16, 2020 No Comments

Essential guidance on legal, risk management, regulatory, and compliance issues for clinical laboratories and employers that are partnering for employee COVID-19 testing.

trending upward covid-19 testing, demand during flu season

COVID-19 Testing May Increase Threefold Over Flu Season, Experts Project

November 13, 2020 No Comments

Two factors influencing demand for COVID-19 testing during flu season, according to recent analysis.

Billing Expert Identifies Reimbursement Hurdles That Clinical Laboratories are Facing and How to Overcome Them

November 11, 2020 No Comments

Interview with Mick Raich of Vachette Pathology on evolving payer and reimbursement rules and resolving billing and reimbursement difficulties for COVID-19 testing.

Demand for SARS-CoV-2 Antigen Tests Shows No Signs of Slowing as Netherlands Orders 9.2 Million Tests from BD

November 9, 2020 No Comments

The Netherlands recently developed a national structure to ensure systematic distribution of SARS-CoV-2 testing and supplies for significantly expanding COVID-19 testing capacity. In the US, wide use of these antigen tests presents two key opportunities for clinical laboratories.

Greek Scientists Develop New Tool Leveraging Clinical Laboratory Test Grouping to Predict Individuals’ COVID-19 Disease Severity

November 4, 2020 No Comments

A particular grouping of several blood tests is needed to utilize this disease severity score. The predictive value of such clinical laboratory testing as a risk assessment model could drive an increase in seven key lab tests.

ampoules or ampules of antiviral drug for COVID-19 treatment

FDA Approves First COVID-19 Antiviral Treatment That May Increase Testing Volumes for Clinical Laboratories

November 2, 2020 No Comments

Three types of clinical laboratory testing support were stipulated with first FDA approval of antiviral drug for COVID-19 treatment.

FDA updates direction on alternative COVID-19 testing supplies

Clinical Laboratory Supply Shortages Are Beginning to Affect More Than Just COVID-19 Testing

October 28, 2020 No Comments

Some 122 clinical laboratories reveal how supply shortages extend beyond COVID-19 testing supplies.

NIH Awards $234 Million to Improve COVID-19 Testing for Underserved Populations

October 26, 2020 No Comments

Possible new source of partnership for clinical laboratories for COVID-19 testing, especially in established networks.

Airports Offer COVID-19 Testing, Opening More Partnership Possibilities for Clinical Laboratories

October 21, 2020 No Comments

Cost points and challenges emerging from new airport COVID-19 testing models.

New Reporting Requirements May See Some Clinical Labs Having to Return Provider Relief Fund Payments

October 19, 2020 No Comments

Proactive steps for healthcare providers, such as clinical laboratories, to prevent a new HHS penalty related to the CARES Act funding they received.

Potential New Demand and Partnership Opportunities for Clinical Laboratories as Airlines Begin Offering COVID-19 Testing to Travelers

October 15, 2020 No Comments

Key points from three major US airlines offering COVID-19 testing as a way to spur air travel in US.

SARS-CoV-2 Viral Load in Patients Seems to Be Decreasing Over Time New Research Shows

October 14, 2020 No Comments

Highlights of a Wayne State University study that seeks to shed light on how viral load measurements are evolving with SARS-CoV-2 and the potential impact on mortality.

Aerosol and spreading SARS-CoV-2 coronavirus

5 Critical Questions Posed in New CDC SARS-CoV-2 Airborne Transmission Guidance

October 12, 2020 No Comments

Five critical questions that must be answered in order to refine SARS-CoV-2 airborne transmission guidance.

Volunteer scientists mobilize in online COVID-19 testing campaign

Thousands of Volunteer Scientists Mobilize to Provide Potentially Valuable Resource for Clinical Laboratories

October 7, 2020 No Comments

Interview with Michael F. Wells, PhD, on growth of a national network of volunteer scientists to assist with COVID-19 clinical laboratory testing and more.

CDC Reverses Guidelines on Asymptomatic Testing for COVID-19, Potentially Increasing Test Volumes for Clinical Laboratories

October 6, 2020 No Comments

The reversal of the asymptomatic testing guidelines may benefit clinical laboratories from a business standpoint moving forward.

Diagnostic Expert Weighs in on the Dangers of Allowing Research Staff to Perform COVID-19 Clinical Testing

October 5, 2020 No Comments

Interview with Matthew J. Binnicker, PhD, on the potential negatives of resolving staffing shortages by using research scientists for clinical laboratory testing.

Many States Failing to Report Antigen-Based COVID-19 Test Results Appropriately

September 30, 2020 No Comments

Four significant findings of a Kaiser Health News state antigen test survey.

As Rollout of POC COVID-19 Testing Begins, One Antigen Test is Having Unexpected False-Positive Results

September 28, 2020 No Comments

Clinical laboratory leaders need to be aware of situations where COVID-19 antigen tests may be inadequate.

Research Continues to Indicate the COVID-19 Pandemic May Have Started Earlier Than Initially Thought

September 25, 2020 No Comments

Points of interest from new UCLA-University of Washington research attempting to trace hospital patients’ symptoms to earlier than thought COVID-19 cases.

CRISPR-Based COVID-19 Testing Technology Continues to Advance with Recently Announced Dartmouth Research Collaboration

September 23, 2020 No Comments

Continued coronavirus research will provide more robust data about the efficacy of CRISPR-based technology as a new diagnostic testing method.

3 Major Moves Positioning Google Sister Company, Verily, to Reckon with Traditional Clinical Laboratories

September 22, 2020 No Comments

Now an FDA EUA for Verily’s SARS-CoV-2 pooled testing that can test 12 samples at once—Google sister company’s clinical laboratory test leanings continue entry into market.

Diagnostics Expert Warns About the Downside of Pooled Testing Except for Limited Situations

September 19, 2020 No Comments

Mayo Clinic Director of Clinical Virology Matthew J. Binnicker, PhD, explains when clinical laboratories should consider pooled testing for SARS-CoV-2.

convalescent-plasma-for-treatment-covid19

Testing Donated Plasma: Clinical Laboratories Should Be Aware of Overlooked Requirement

September 18, 2020 No Comments

To clear up any ambiguity, the EUA further clarifies that only one testing option is permitted under the initial EUA.

Notable Among CLIA-Certified COVID-19 Testing Laboratory Upstarts

September 16, 2020 No Comments

If the COVID-19 pandemic continues into 2021, then clinical laboratories can expect many new competitors for SARS-CoV-2 testing.

Abbott SARS-CoV-2 Antigen Test Receives EUA, Had $760 Million Deal Pending With Federal Government in Less Than 48 Hours

September 14, 2020 No Comments

Federal collaboration with Abbott materializes into contract quickly after BinaxNOW COVID-19 Ag Card EUA announcement.

Laboratory Expert Identifies Viral Load and Co-infections as Commonly Overlooked Tests for COVID-19 Patients

September 10, 2020 No Comments

Pathologist Frederick (Fritz) Kiechle, MD, PhD, reviews two potential testing strategies associated with COVID-19 management.

covid 19 testing demand amid lab supply shortages

CDC Updates SARS-CoV-2 Testing Guidelines, Reducing Recommendations for Testing Those Who Have Been Exposed

September 8, 2020 No Comments

With another change to CDC COVID-19 testing guidance, clinical laboratories may begin to see more fluctuations in test volumes because of potentially conflicting federal, state, and local testing guidance.

Important biomarker changes with COVID-19 inform clinical laboratory testing strategies

Overlooked Clinical Biomarkers Play Important Role in Determining and Predicting COVID-19 Disease Severity

September 4, 2020 No Comments

In an exclusive interview, pathologist Frederick (Fritz) Kiechle, MD, PhD, reviews biomarker changes and related clinical laboratory testing at different disease stages of COVID-19.

Virus genome sequencing contact tracing information moving

Contact Tracing Could be Augmented by Tracking Variants of SARS-CoV-2 Says Dartmouth Researcher

September 2, 2020 No Comments

Joel Lefferts, PhD, of the Geisel School of Medicine at Dartmouth and Clinical Genomics and Advanced Technology (CGAT) at Dartmouth-Hitchcock Medical Center (DHMC), explains how SARS-CoV-2 virus genome sequencing and tracking the variants will complement contact tracing.

CDC Provides Updated Interim Guidance for Rapid Antigen Testing for SARS-CoV-2

September 1, 2020 No Comments

CDC continues to change SARS-CoV-2 diagnostic testing guidance.

Yale researchers develop open source saliva test for SARS-CoV-2

New Open Source Saliva-Based SARS-CoV-2 Diagnostic Test Intends to Reduce Lab Supply Chain Stress

August 31, 2020 No Comments

What the open source protocol means to COVID-19 testing laboratories.

Ohio Governor’s False Positive COVID-19 Result Impacts Public Perception of SARS-CoV-2 Antigen Testing

August 25, 2020 No Comments

What happened with Ohio Gov. Mike DeWine’s coronavirus test.

Dartmouth Researcher Discusses Implications SARS-CoV-2 Mutations will Have on Testing by Clinical Laboratories

August 24, 2020 No Comments

In an exclusive interview, Dr. Joel Lefferts, a genomics specialist at Dartmouth’s Geisel School of Medicine, discusses coronavirus research around sequencing a small subset of the SARS-CoV-2 virus.

Online COVID-19 Digital Pathology Repository Provides Clinical Pathologists with Access to High-Quality COVID-19 Tissue Images

August 21, 2020 No Comments

Whole slide images, annotations, and metadata in the digital pathology repository will be used as a reference data set for education, research, and future clinical trials aimed at limiting further infection, disease, and death.

Order for 3.5 Million POC SARS-CoV-2 Antigen Tests May Decrease Need for Clinical Lab-Based PCR Testing

August 20, 2020 No Comments

A look at substantial state and federal efforts to scale point-of-care rapid antigen testing for SARS-CoV-2 coronavirus.

Clinical Laboratories May be Overlooking Coagulopathy Tests That Should Be Ordered for COVID-19 Positive Patients

August 19, 2020 No Comments

In an exclusive interview, Joshua Hayden, PhD, DABCC, FAACC, of Norton Healthcare, discusses COVID-19 associated coagulopathy, PE, and a potential clinical laboratory testing strategy for COVID-19 positive follow-ups.

CDC Revises Guidelines for COVID-19 Positive Patients, Eliminating the Need for Repeat Testing

August 16, 2020 No Comments

Three points of impact included in new CDC quarantine guidelines, that will likely affect clinical laboratory PCR test volume.

More will be tested using rapid POC COVID tests

HHS Invests $24 Million Into Scaling the Production and Accessibility of POC SARS-CoV-2 Antigen Tests, Reducing Need for Clinical Lab Based Tests

August 14, 2020 No Comments

As new testing options become available, the trend of diagnostic tests moving outside of clinical laboratory settings may soon begin to impact the volume of these tests.

Medical search dogs training to detect COVID-19

New Research Indicates Dogs Can Detect COVID-19 by Smell, Raising Questions About Potential Applications

August 11, 2020 No Comments

Exploring a new disease detection method for COVID-19 in the UK.

HHS Directs $5 Billion For Nursing Homes to Perform Weekly Testing on Staff, But Clinical Laboratories are Unlikely to Benefit

August 11, 2020 No Comments

New nursing home guidelines by CMS now require COVID-19 testing for nursing home staff in states with infection rates of 5% or more.

Nursing Homes: First Wave of Testing Begins as HHS’ Large Scale Distribution of SARS-CoV-2 POC Antigen Tests Takes Shape in Hotspots

August 10, 2020 No Comments

While the antigen test initiative of HHS will play a role in reducing the spread of COVID-19 among vulnerable populations and surrounding communities, mass rapid point of care testing will have implications for clinical laboratories.

Testing wastewater sewage for SARS-CoV-2 RNA

Potential New Demand for SARS-CoV-2 Testing as Municipalities Explore Testing Sewage to Monitor Infection Trends

August 5, 2020 No Comments

While feces are not thought to transmit SARS-CoV-2, there are genetic materials found in the feces of infected individuals, that can be detected by PCR testing.

Routine COVID-19 Screening of Asymptomatic People Creates Increased Demand for SARS-CoV-2 Diagnostic Testing

August 3, 2020 No Comments

Screening asymptomatic people regardless of known or unknown COVID-19 exposure is useful, but it will be important to ensure that this testing is used appropriately and that contingency plans are in place to modify operations based on test results.

New Meta-analysis Reveals Significant Weaknesses in Evidence Base for Point-of-Care SARS-CoV-2 Serology Tests

July 28, 2020 No Comments

New research casts doubt on the evidence that SARS-CoV-2 serology testing yields useful data.

Implications of Revocation of SARS-CoV-2 Serology EUA May Indicate FDA Enforcement That Could Affect Clinical Laboratories’ COVID-19 Tests

July 27, 2020 No Comments

With serological assays for SARS-CoV-2 widely available, uncertainty remains around the accuracy of these tests. The revocation of Chembio’s SARS-CoV-2 serology EUA could indicate broader and stricter enforcement by the FDA.

Universal COVID-19 testing coverage demanded by some

Congressional Democrats Urge a Revisit of COVID-19 Related Coverage Guidelines

July 23, 2020 No Comments

What members of Congress wrote in response to federal departments’ interpretation and guidance of health insurers’ COVID-19 testing payment obligations.

Analysis of nationwide clinical laboratory COVID-19 lab test reports

Redfield Defends Bypassing the CDC on Crucial COVID-19 Data

July 22, 2020 No Comments

The National Healthcare Safety Network (NHSN) module was one of four pathways to reporting crucial COVID-19 data to HHS. The NHSN module was deactivated with the TeleTracking HHS Protect portal becoming the primary pathway for hospitals, hospital laboratories, and other healthcare facilities. The decision has met criticism.

As Employers Weigh Reopening, CVS Announces New SARS-CoV-2 Testing Product for Employees, Universities

July 18, 2020 No Comments

Overview of what CVS Health announced and described as a comprehensive, customizable COVID-19 testing solution for employers and universities.

Clinical Laboratories Should Anticipate Increased Supply Chain Disruptions as Demand for SARS-CoV-2 Diagnostic Testing Grows

July 16, 2020 No Comments

Large diagnostic clinical laboratories publicly share pain of surge in COVID-19 test demand. Recent lab pro letter urges “visibility into the process of supply allocation.” Smaller labs may be getting shortchanged.

Google Verily public health partnership for COVID-19 employee screening

Google Sister Company, Verily Life Sciences Introduces Employee Health Screening Tool That Could Drive COVID-19 Test Volumes for Clinical Laboratories

July 15, 2020 No Comments

Employee screening tools being developed by technology companies create unique opportunity for clinical laboratories to pursue strategic partnerships.

Mapping COVID-19 without laboratory testing

Technology Allows Researchers Insights Into the Origins of the COVID-19 Outbreak Without Clinical Laboratory Testing?

July 13, 2020 No Comments

Points of interest in the Harvard analysis of observations in Wuhan, China, as early as August 2019, that share new insights into the origins of the COVID-19 pandemic.

return to work covid-19 testing policy developing

EEOC Prohibits Employers from Requiring Employees to Have SARS-CoV-2 Antibody Testing to Return to Work

July 8, 2020 No Comments

What the US Equal Employment Opportunity Commission (EEOC) updated in its June 17 guidance to employers on COVID-19 testing.

convalescent plasma therapy as a COVID-19 treatment

Nationwide Push for Convalescent Plasma Expected to Increase the Need for SARS-CoV-2 Serology and Specialized Medical Laboratory Testing

July 8, 2020 No Comments

An interview with Mayo Clinic’s Elitza Theel, PhD, presents an overview of the state of convalescent plasma treatment for COVID-19.

Several points of the preanalytical clinical laboratory testing process affect quality of results

Specific COVID-19 Preanalytical Issues Clinical Laboratories Should Consider

July 6, 2020 No Comments

Explanation of preanalytical issues with SARS-CoV-2 (COVID-19) testing in clinical laboratories and what to expect in the event of a second wave of infections in the fall.

FDA Sends Warning Letters to Companies Improperly Marketing At-Home SARS-CoV-2 Antibody Tests

July 1, 2020 No Comments

At-home SARS-CoV-2 warning letters and implications for clinical laboratories and pathologists.

Clinical Laboratories May Be Affected by Health Insurers’ Push to Reduce Their Payment Obligations for COVID-19 Tests

June 24, 2020 No Comments

Overview of complaints around COVID-19 test payment expectations and attempts to reduce health insurers’ legislative and regulatory requirements.

Saliva based testing for COVID-19 started at Rutgers’ RUCDR Infinite Biologics, where this workstation can process up to 10,000 saliva samples per day. Photo credit: David Sokolowski

Saliva Offers Unique Benefits and Potentially Wider Applications as a SARS-CoV-2 Specimen

June 22, 2020 No Comments

In an exclusive interview, Frederick (Fritz) Kiechle, MD, PhD, explains how and why saliva has emerged as a sample type for detecting SARS-CoV-2, the coronavirus that causes COVID-19.

Educational webinar hosted by COVID-19 STAT and Dark Daily on quality and accuracy of serological tests

Westgard QC Webinar Part 2 Points of Interest: Achieving High Confidence Levels in the Quality and Accuracy of COVID-19 Serology Tests

June 18, 2020 No Comments

Pearls from the 90-minute educational webinar, “Achieving High Confidence Levels in the Quality and Accuracy of Your Clinical Lab’s Chosen COVID-19 Serology Tests,” presented June 11 and featuring James O. Westgard, PhD, and Sten Westgard.

A drive up COVID-19 testing site, June 2020, at an empty pharmacy in Birmingham, Alabama

Clinical Laboratories Face Reimbursement Uncertainties Over SARS-CoV-2 Testing for Asymptomatic Individuals

June 17, 2020 No Comments

In an exclusive interview, Danielle Sloane of Bass, Berry and Sims, discusses potentially tricky reimbursement for SARS-CoV-2 asymptomatic testing.

FDA-serology-test-removed-not-for-distribution

More Serological Tests Removed Since Initial Listings: Changing FDA Regulations Complicate Selecting and Using SARS-CoV-2 Serology Assays

June 15, 2020 No Comments

Latest on SARS-CoV-2 serology tests that have been removed or withdrawn from the FDA’s notification list, plus FDA’s notes on performance of available tests.

physician office practices suffering due to COVID-19 complications and losses

Drop in Physician Office Employment Levels Indicates Lasting Volume Changes for Clinical Labs

June 11, 2020 No Comments

Impact of lower outpatient testing volumes on clinical laboratory and anatomic pathology services: Is there a bright side?

Sourced-US-House-of-Representatives-Session-Room-House-Press-Gallery-Twitter

Two Pending Bills in Congress May Provide $750 Million to Support Clinical Laboratories Performing COVID-19 Testing

June 10, 2020 No Comments

Explanation of HR 7025 and HR 7026 for clinical laboratories, hospitals, primary care practices, and other healthcare providers.

Lack of Coherent Testing Strategy Creates Uncertainties for Clinical Laboratories about COVID-19 Testing Volumes

June 5, 2020 No Comments

Influential quotes by Gary Procop, MD, MS, of the Cleveland Clinic, on the role of clinical laboratory and anatomic pathology group leaders in developing a national COVID-19 testing strategy.

Clinical Laboratories May Lose SARS-CoV-2 Testing Volumes to Veterinarian Labs

June 5, 2020 No Comments

Implications of blurring the lines between human testing laboratories and veterinarian labs.

Screenshot of McGovern Institute video available at https://mcgovern.mit.edu/2019/01/01/crispr-in-a-nutshell/ and explaining CRISPR in a nutshell

CRISPR Technology in SARS-CoV-2 Diagnostic Testing May Provide Clinical Laboratories With More Cost Effective, Faster Testing Method

June 3, 2020 No Comments

With this recently approved testing paradigm that has emerged within the last few weeks, a significant question remains.

Emerging SARS Contact Tracing Technologies May Significantly Increase Need for COVID-19 Testing

June 1, 2020 No Comments

Though questions may remain about the reach and risks of the digital technologies used for COVID-19 contact tracing systems, clinical laboratory directors and pathologists will need to watch for changes in test demand.

Q&A from Westgard Webinar on Quality in Selecting COVID-19 Serology Tests

May 28, 2020 No Comments

Topics include adopting a platform that already has an FDA EUA, validating rapid test kits for use at remote sites, and other coronavirus antibody cross reactivity.

Points of Interest from Westgard Webinar on Quality and Strategies for Selecting COVID-19 Serology Test Methods

May 27, 2020 No Comments

Some COVID-19 serology testing methods are demonstrating inadequate performance, according to Sten Westgard, who explained study data during a May 21 webinar. Learn how to assess fast-moving developments.

Questioning Appropriate SARS-CoV-2 Test Utilization (Part 2)

May 26, 2020 No Comments

Mayo Clinic Laboratories is examining if utilization of SARS-CoV-2 serology testing may be optimized when coupled with PCR testing. Dr. Matthew J. Binnicker explains the lab test utilization strategy being evaluated to develop risk profiles and increase risk awareness.

Clinical Laboratories Must Protect Themselves Against Litigation Risk with SARS-CoV-2 Testing

May 25, 2020 No Comments

An exclusive interview with Richard S. Cooper of the firm McDonald Hopkins addresses two categories of legal risks that have become evident for clinical laboratories with COVID-19 testing.

Questioning Appropriate SARS-CoV-2 PCR Test Utilization (Part 1)

May 21, 2020 No Comments

Repeat SARS-CoV-2 testing has been an issue that many clinical laboratories and pathology groups have encountered, making it a potential lab test utilization issue.

House Democrats disrupt over unreliable serology testing methods

FDA Acknowledges Tradeoffs of Early SARS-CoV-2 Serological Tests

May 18, 2020 No Comments

In mid-March, it was critical to provide regulatory flexibility for serology test developers. However, two major issues have surged through public and political discourse.

Webinar with Westgards Will Help Your Clinical Laboratory Choose the Right Strategy Around the Coming Wave of Serology Testing

May 18, 2020 No Comments

There’s good news coming for clinical laboratories as a tidal wave of orders for COVID-19 serology tests head their way while healthcare policymakers call upon

Can Crowdsourced Data on the Pandemic’s Spread Help Hospitals and Clinical Laboratories?

May 13, 2020 No Comments

Crowdsourced data during COVID-19 pandemic has implications for clinical laboratories and pathology groups, including possibly predicting test volume.

CDC Creates Consortium to Track SARS-CoV-2 Through Genetic Sequencing

May 12, 2020 No Comments

What we know about the CDC’s SPHERES’ (SARS-CoV-2 Sequencing for Public Health Emergency Response, Epidemiology, and Surveillance) objectives.

Northwell Health Labs Uses Mobile Phlebotomy App to Better Serve Patients, Increase Test Volume and Revenue During COVID-19 Outbreak

May 11, 2020 No Comments

Christopher Zavala of Northwell Health Labs explains use of Northwell’s mobile collections services app for blood draws, before and during the COVID-19 pandemic.

FDA Seeks Path Forward for How It Regulates the Development of COVID-19 Clinical Laboratory Tests

May 11, 2020 No Comments

Roger D. Klein, MD, JD, explains how federal regulation around clinical laboratory developed tests (LDTs) has evolved during the COVID-19 pandemic.

DOJ Indicts Individual for COVID-19 Test Bribes Under Anti-Kickback

May 6, 2020 No Comments

Understand how the anti-kickback law connects to the Erik Santos COVID-19 test bribe case, plus EKRA.

COVID-19 Disruptions of Supply Chains are Challenge for Clinical Laboratories to Bring Value to Hospitals and Healthcare Networks

May 1, 2020 No Comments

One supply chain expert has several recommendations on how hospitals and clinical laboratories can respond to improve their access to needed supplies.

Antibody Studies in Three Cities Hint at Greater Magnitude of COVID-19 Exposure

April 28, 2020 No Comments

Review three briefs about first COVID-19 antibody studies in three cities, and what these studies suggest about demand for serology testing.

Hospital-based Clinical Laboratories Need to Submit Daily Reports on COVID-19 Test Activity to Federal Government

April 25, 2020 No Comments

Explanation and discussion of federal guideline for daily clinical laboratory COVID-19 test reporting to FEMA.

Clinical Labs and Pathology Groups Hit With Big Drop in Cash Flow as Fewer Patients Visit Their Physicians, Have Elective Surgeries

April 22, 2020 No Comments

Understand changes clinical laboratories and anatomic pathology groups are experiencing in testing volumes as a result of the COVID-19 pandemic.

3 Essentials for Setting Up COVID-19 Serology Testing in the Lab

April 22, 2020 No Comments

An exclusive interview and podcast with Frederick (Fritz) Kiechle, MD, PhD, explores what actions clinical laboratories can take to implement reliable antibody tests and benefit from potential serology testing reimbursement.

Briefings

COVID-19 Causes Genetic Changes that Create Long-Haul COVID-19 Symptoms, Researchers Find

What Texas researchers found that changed baseline gene expression in airway cells.

May 11, 2021 No Comments

Briefings

Six-Foot Rule for Preventing the Spread of COVID-19 is Likely Useless, MIT Researchers Find

Ultimately this research shows that the 6-foot rule should not be a core component of COVID-19 spread mitigation strategies, says MIT professor.

May 4, 2021 No Comments

Briefings

Long-Haul COVID-19 Emerges as a Concern, Potentially Increasing Need for More COVID-19 Antibody Testing

Clinical laboratories would test for COVID-19 antibodies in those with long-haul COVID-19 symptoms but are unsure if they were ever infected with SARS-CoV-2.

April 26, 2021 No Comments

Briefings

Nationwide COVID-19 Testing Program in Slovakia Proves the Effectiveness of a National Testing Program

The recent research on Slovakia’s national testing program provides a potential model for containing infectious disease outbreaks.

April 20, 2021 No Comments

Briefings

Clinical Laboratories Should Anticipate Gender-Dependent Differences in COVID-19 Antibody Levels, New Study Suggests

Clinical laboratories should be aware of the potential for quantitative differences in COVID-19 antibody levels, as demand for antibody testing may increase.

April 13, 2021 No Comments

Briefings

Vaccine Breakthrough Provides Process That Produces $1 Vaccines in Less Than Three Weeks of Development

As new vaccine breakthrough research continues, Virginia Tech and UVA virologists develop innovative COVID-19 vaccine production platform.

April 5, 2021 No Comments

Webinars

Life After COVID: Positioning Your Lab for Success in a Post-Pandemic World

Now available for streaming: How does your lab begin to prepare itself to succeed in a post-pandemic world? Start your plan now to navigate the transition. Attend this complimentary webinar and hear the ways in which your lab’s current testing can create assets for the future, and how you can best position your lab for success in a post-pandemic environment by leveraging your diagnostic data as a strategic asset.

March 8, 2021 No Comments

Webinars

Emerging SARS-CoV-2 Mutations: Impact on Thermo Fisher Scientific Assay Performance

Available for free streaming: Learn the important clinical implications (epidemiological, prognostic, and predictive) of new COVID-19 “variants of concern,” the importance of early detection of these variants, and steps your lab can take to confidently detect the COVID-19 virus with a very high degree of specificity and sensitivity, given new variants.

February 24, 2021 No Comments

Webinars

Pooled Testing: What Your Lab Needs to Know About Managing a Fall/Winter Surge in the COVID-19 Pandemic

Gain a clear understanding of when it makes sense to implement pooled testing, specifically for COVID-19, understand the potential benefits of pooled testing, as well as learn the important features to look for when selecting pooled testing workflow technology.

November 5, 2020 No Comments

Webinars

Leveraging IT for Your Laboratory Outreach Strategy During the COVID-19 Pandemic

Learn how the right suite of applications can empower your lab through technology, help you tailor your outreach program to your lab clients, and as a result improve market share with an efficient and effective outreach strategy.

August 6, 2020 No Comments

Webinars

Start and Scale COVID-19 Testing with Essential Tools that Support the Business and Workflow of Your Lab

Take away from this webinar a clear understanding of how your lab can rapidly ramp up its COVID-19 testing, offer the right support for the right tests (RT-PCR, serology) and effectively serve physician customers, while maintaining adherence to security and compliance requirements.

June 19, 2020 No Comments

Webinars

Achieving High Confidence Levels in the Quality and Accuracy of Your Clinical Lab’s Chosen COVID-19 Serology Tests

Now that your clinical laboratory has decided on which COVID-19 serology test it will buy and offer to physicians, patients, and employers with wellness screening programs, your lab team must succeed with the challenging process of validation. This is required—not just for your lab to meet CLIA requirements—but for your lab team to have high confidence that the COVID-19 serology test results are accurate, reproducible, and appropriate for use in patient care. Join us for this program as James O. Westgard and Sten Westgard, lead you through the process.

May 24, 2020 No Comments

Briefings

COVID-19 Causes Genetic Changes that Create Long-Haul COVID-19 Symptoms, Researchers Find

What Texas researchers found that changed baseline gene expression in airway cells.

May 11, 2021 No Comments

Briefings

Six-Foot Rule for Preventing the Spread of COVID-19 is Likely Useless, MIT Researchers Find

Ultimately this research shows that the 6-foot rule should not be a core component of COVID-19 spread mitigation strategies, says MIT professor.

May 4, 2021 No Comments

Briefings

Long-Haul COVID-19 Emerges as a Concern, Potentially Increasing Need for More COVID-19 Antibody Testing

Clinical laboratories would test for COVID-19 antibodies in those with long-haul COVID-19 symptoms but are unsure if they were ever infected with SARS-CoV-2.

April 26, 2021 No Comments

Briefings

Nationwide COVID-19 Testing Program in Slovakia Proves the Effectiveness of a National Testing Program

The recent research on Slovakia’s national testing program provides a potential model for containing infectious disease outbreaks.

April 20, 2021 No Comments

Briefings

Clinical Laboratories Should Anticipate Gender-Dependent Differences in COVID-19 Antibody Levels, New Study Suggests

Clinical laboratories should be aware of the potential for quantitative differences in COVID-19 antibody levels, as demand for antibody testing may increase.

April 13, 2021 No Comments

Briefings

Vaccine Breakthrough Provides Process That Produces $1 Vaccines in Less Than Three Weeks of Development

As new vaccine breakthrough research continues, Virginia Tech and UVA virologists develop innovative COVID-19 vaccine production platform.

April 5, 2021 No Comments

Dear Colleague,

In these challenging times for our colleagues in clinical laboratories, pathology practices and hospital administration, The Dark Intelligence Group (TDIG) — through generous grants from our partners — is bringing you the COVID-19 STAT Intelligence Briefings.

We’ve added analysts, writers and skilled editors to the COVID-19 STAT team to uncover, analyze, and immediately report to you what’s happening with the SARS-CoV-2 pandemic, packaged with the insights you need to deliver quality testing for patient care and keep your lab’s financial ship afloat. As part of our mission, we are also bringing you real-time data from our partners around testing that you will not find anywhere else.

Please let me know how we can better improve this service to fit your needs. If you would like to offer a grant to keep our mission going with this site, please contact me at rmichel@darkreport.com.

Sincerely,

Robert L. Michel
President, Founder
The Dark Intelligence Group

Briefings

Actionable Analysis News and Intelligence From Interviews with Leading Nationwide Experts

COVID-19 TESTING DATA

Helping Your Lab Stay Afloat During Challenging Times