TDR Insider Archives - The Dark Intelligence Group

Will HHS Ruling on COVID-19 LDTs Be Good or Bad for Lab Reimbursement?

This is an excerpt of a 1,028-word article in the September 14, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. WHILE SOME LABS CELEBRATE THE PERCEIVED FLEXIBILITY that comes from not having to get an emergency use authorization (EUA) for COVID-19 laboratory-developed tests (LDTs), there is a potential …

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FDA Will Have No Authority Over Laboratory-Developed Tests, HHS Says

TDR Insider / By Robert Michel

This is an excerpt of a 2,029-word article in the August 24, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: A directive from the federal Department of Health and Human Services (HHS) may have long-lasting implications for the federal Food and Drug Administration’s efforts …

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Amazon Targets COVID-19 Testing in its New Lab-Building Venture

TDR Insider / By Robert Michel

This is an excerpt of a 1,980-word article in the August 3, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: For pathologists and clinical lab directors, Amazon’s nascent COVID-19 testing venture for employees could be a significant concern given that the e-commerce company could disrupt …

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Is COVID-19 Pooled Testing Good for Labs, Bad for IVDs?

TDR Insider / By Robert Michel

This is an excerpt of a 1,420-word article in the July 13, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: Pooled testing for COVID-19 could be a double-edged sword for clinical labs and in vitro diagnostics companies. Offering the advantage of reducing the number …

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FDA Says 8 of 11 Tests Fail in Serology Test Review

TDR Insider / By Robert Michel

This is an excerpt of a 1,970-word article in the June 22, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: After introducing some 200 serological assays onto the market in March and April with little or no review, as of this writing …

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COVID-19 Pandemic Erodes Cash Flow at Clinical Labs

TDR Insider / By Robert Michel

This is an excerpt of a 1,209-word article in the June 1, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: Every day, national news headlines scream about the shortage of SARS-CoV-2 lab tests needed to manage the COVID-19 pandemic. Recently, national news coverage has begun …

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California Research Team Analyzes Performance of 12 Serological Tests

TDR Insider / By Joseph Burns

This is an excerpt of a 2.241-word article in the May 11, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: Researchers with the COVID-19 Testing Project used a multidisciplinary effort to analyze and compare the performance of 12 serological tests, and shared their results with …

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Companies Saw Big Drop in Lab Revenue from Mid-March

TDR Insider / By Joseph Burns

This is an excerpt of a 2,083-word article in the April 20, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: In response to the coronavirus outbreak, patients stopped seeing their doctors for routine care and hospitals ceased doing elective services. With fewer test referrals, clinical …

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At the Epicenter, Northwell’s COVID-19 Lab Data Adds Value

Leave a Comment / TDR Insider / By Joseph Burns

This is an excerpt of a 3,210-word article in the March 30, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: This intelligence briefing provides a valuable look inside a clinical laboratory that is at ground zero in a city and state that is experiencing the …

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Northwell Lab Team Validates Novel Coronavirus Test on Fast Timeline

Leave a Comment / TDR Insider / By Mary Van Doren

This is an excerpt of a 2,375-word article in the March 9, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: Clinical labs are working with haste to develop a novel coronavirus test. In this rare behind-the scenes look, laboratorians can learn about …

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