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

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Free COVID-19 STAT Intelligence Briefings Email Digest

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

Author: The Dark Intelligence Group

FDA Changes Storage Requirements for Pfizer COVID-19 Vaccine, Facilitating Faster and More Widespread Use

FDA maze of regulations

New storage requirement for Pfizer vaccine makes it easier for clinical laboratory personnel to access vaccine.

FDA Issues New Guidance for Test Developers on How to Plan for Genetic Variants

FDA maze of regulations

Toward the performance of diagnostic tests, three main components are addressed by this new guidance.

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

time running out for COVID-19 test stockpile in Hawaii

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

New Jersey Laboratory Sues Thermo Fisher, Alleging Problems With COVID-19 Testing Technology

lawsuit legal and business

Notice of complaint filed: TaqPath COVID-19 Combo Kit

Emerging SARS-CoV-2 Mutations: Impact on TaqPath Assay Performance and its Clinical Implications

ThermoFisher-DarkDaily-Webinar

Attend this webinar and 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.

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

CDC COVID pathology slide

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

White House Announces Over $1.6 Billion to Increase Availability of COVID-19 Testing

calculator concept covid19 testing calculator

New federal funding for pandemic response moves in three directions.

FDA Issues EUA for Point-of-Care COVID-19 PCR Test

FDA maze of regulations

Advancing Visby Medical’s PCR test, a new EUA for the “personal” PCR test expands its use to patient care settings operating under certain certificates.

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

clinical sensitivity and specificity of direct POCTs, selected, that met the Who's Target Product Profile direct detection of SARS-CoV-2

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

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

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

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

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