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Search Results for: COVID-19

DOJ $6B Fraud Crackdown Charges 345 Defendants

Laboratory Compliance /

CEO SUMMARY: Department of Justice cases involving clinical labs or molecular test claims may represent about half (or about $3 billion) of the total fraudulent claims. Those claims stem from genetic testing, urine-drug and other tests, and healthcare services, the DOJ said. In addition, the DOJ reported that labs were involved in filing fraudulent claims for lab tests while working with […]

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LIS and Lab Informatics Vendors Report Second Quarter Earnings

Laboratory Information Systems /

IT’S BEEN A CHALLENGING YEAR for companies that sell laboratory information systems (LIS) to the nation’s clinical laboratories. Because of the SARS-CoV-2 outbreak, labs have delayed decisions to acquire or upgrade their existing LIS systems, as well as previously-scheduled installs of new or upgraded systems. Two major sellers of LIS products in the United States are Cerner Corporation and Roper Technologies’ Sunquest Information Systems. Both

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October 5, 2020 Intelligence: Late-Breaking Lab News

Late Breaking Lab News /

Guess who will be partnering with the US Department of Veterans Affairs to support its wider use of digital pathology? It’s Google! Last month, it was announced that the Defense Innovation Unit (DIU) of the Department of Defense (DoD) had selected Google Cloud “to prototype an artificial intelligence-enabled digital pathology solution to help detect cancer on multiple disease areas.” This relationship can be expected to encourage acceptance and wider use of digital

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Coming Soon: a Different Clinical Lab Industry

Commentary and Opinion by R. Lewis Dark /

“Keep your eye on the ball” is an idiom that originated with baseball. The idea is that every player on the field should, at all times, know where the ball is so that they can be ready to do their job when the ball comes their way. This is excellent advice for clinical lab administrators and pathologists during

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Texas Company Operates 400 COVID-Collection Sites

Clinical Laboratory /

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 done since 2016 in partnership with some of the nation’s largest retail pharmacy and grocery chains. Under the HHS contract, eTrueNorth

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Franciscan Missionaries Sells Lab Outreach Business to LabCorp

Laboratory Management /

SINCE THE ONSET OF THE PANDEMIC IN LATE FEBRUARY, the nation’s two largest clinical lab companies have announced only two acquisitions of hospital laboratory outreach programs, one in June and one this month. Last week, LabCorp announced its acquisition of the clinical ambulatory laboratory business of Franciscan Missionaries of Our Lady Health System (FMOLHS) in Baton Rouge, La. Earlier, on June 23, Quest Diagnostics

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New York Firm to Build CLIA Labs in Shipping Containers

Clinical Laboratory Trends /

CEO SUMMARY: In many respects, the COVID-19 pandemic is like a gold rush for entrepreneurs. Federal and state governments, colleges, employers, school districts, and other entities need COVID-19 tests and tens of billions of dollars are available to pay for such tests. This modern gold rush has encouraged companies such as Amazon and Alphabet/Google to build their own clinical labs. Now

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September 14, 2020 Intelligence: Late-Breaking Lab News

Late Breaking Lab News /

Alphabet, Inc., the parent of Google, is expanding its COVID-19 testing activities. In recent months, Verily Life Sciences—a division of Alphabet devoted to research into life sciences—organized a clinical laboratory for COVID-19 testing. It obtained CLIA certification and is licensed with the State of California. In a blog, Verily’s Head of Pathology, Deb Hanks, MD, wrote that the lab had “verified the performance of the SARS-CoV-2 RT-PCR test

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

TDR Insider /

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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HHS ‘Stands Down’ FDA on Its Oversight of LDTs

Laboratory Compliance /

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 that labs “are not required” to obtain an FDA emergency use authorization or FDA clearance of LDTs. Clinical labs welcomed

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