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lab testing services

Pathology Lab Transforms, Runs 1M COVID-19 Tests

CEO SUMMARY: Last spring, a histopathology lab in Illinois began running molecular COVID-19 tests and decided the clinical side of the lab would focus exclusively on PCR testing for COVID-19. The challenge was how to access a reliable source of test kits, reagents, and supplies to o…

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Memphis Path Lab Pivots to COVID, Pooled Testing

CEO SUMMARY: When routine testing volume declined sharply last winter and spring, one of the nation’s largest anatomic pathology groups added testing for COVID-19 and boosted revenue significantly. Since then, the laboratory has become the first in the nation to gain an Emergency …

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Medicare Pays 500% More for Molecular Test Claims

CEO SUMMARY: Rapid growth in what Medicare spent for molecular tests in recent years may lead federal investigators to increase scrutiny of fraudulent billing for clinical laboratory and molecular pathology tests, according to a lab consultant who has tracked such spending in recent y…

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High-Complexity Mobile Labs for COVID-19 Testing

CEO SUMMARY: Demand for high-complexity mobile coronavirus testing facilities is high, according to the CEO of a start-up company building 25 clinical labs in mobile trailers that can do hundreds of tests per eight-hour day. Employers, schools, event organizers, and other entities all…

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Understanding COVID-19’s Changes to Lab Industry

CEO SUMMARY: With the SARS-CoV-2 pandemic about to enter its eighth month in the United States, it remains difficult to predict whether the pandemic will strengthen with the fall influenza season or steadily diminish. What is clear to most pathologists and clinical laboratory executiv…

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Texas Company Operates 400 COVID-Collection Sites

CEO SUMMARY: In April, the federal Department of Health and Human Services contracted with eTrueNorth to operate COVID drive-through specimen-collection sites under the Community-Based Testing Sites program. The drive-through sites are an extension of non-COVID testing the company has …

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

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 implic…

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HHS ‘Stands Down’ FDA on Its Oversight of LDTs

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 to assert regulatory oversight of laboratory-developed tests (LDTs). In a statement last week, HHS said t…

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Specimen Volume Returns at Dallas-based ProPath

CEO SUMMARY: Like other physician specialties, anatomic pathology saw a dramatic collapse in the number of daily procedures with a corresponding decline in cash flow as the COVID-19 pandemic hit with full force in March, April, and May. The good news is that the daily volume of tissue…

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Quest Reports 46% Decline in New Cancer Diagnoses in March

ONCE SHELTER-IN-PLACE ORDERS WERE ENACTED IN MARCH because of the COVID-19 pandemic, the number of new diagnoses of cancer declined sharply in the United States. Newly-published data confirms this fact. The data also support the warnings of anatomic pathologists that—because of the pandemi…

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