Since 1995, Reliable Business Intelligence for Clinical Laboratories, Pathology Groups and Laboratory Diagnostics

February 2021

CAP Loses Accreditation Clients to Joint Commission

The Dark Report / By R. Lewis Dark

CEO SUMMARY: Over the past 18 months, several prominent national health systems decided to shift their CLIA laboratory accreditation services away from the College of American Pathologists and to The Joint Commission. These shifts from one accrediting body to another will involve hundreds of hospital laboratories. Such a shift in the market for CLIA accreditation …

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Clinical Labs Have the Opportunity to Deliver Value

Commentary and Opinion by R. Lewis Dark / By R. Lewis Dark

FOR DECADES, PATHOLOGISTS AND CLINICAL LABORATORY PROFESSIONALS have called attention to the single most powerful resource possessed by their lab organizations: patient lab test data. Everyone in lab medicine is familiar with the oft-repeated statement that the cost of lab testing is about 3¢ to 5¢ on the healthcare dollar, but lab test data is involved in 60% …

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What’s Ahead for Labs? It’ll Be Quite Different

Clinical Laboratory Trends / By Robert Michel

CEO SUMMARY: In many ways, the nation’s clinical laboratories performed magnificently in response to the SARS-CoV-2 outbreak last winter. But that magnificent performance has taken its toll on the infrastructure and personnel within these labs. The Dark Report provides insights into four key factors common to all clinical laboratories, particularly those that currently perform large numbers of COVID-19 tests. The following …

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Academic, Commercial Collaboration for Testing

Clinical Laboratory / By Robert Michel

CEO SUMMARY: In several important ways, this collaboration involving an academic clinical laboratory and a commercial company has paid big dividends, not just for the two partners, but also the parent university that oversaw the project. The two partners developed a SARS-CoV-2 test, then manufactured it in large quantities. The molecular COVID-19 test, named Clarifi, uses a saliva specimen and has …

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SARS-CoV-2 Variant Sequencing Creates New Opportunities for Labs

TDR Insider / By Robert Michel

This is an excerpt of a 2,964-word article in the February 8, 2021 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: Variants of the COVID-19 virus are appearing across the world. Recent data show the same variants will infect people in several different countries. …

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Critics Say New At-Home Test Is Expensive and Late to Market

Lab Marketplace / By Robert Michel

ONCE AGAIN, THE COMBINATION of the pandemic and the federal government may be creating a credible new competitor in the in vitro diagnostics (IVD) industry. This time, the lucky company is Ellume, which was just awarded $231.8 million from the Biden administration to scale up production of a home test for SARS-CoV-2. Ellume was given an emergency-use authorization (EUA) from the federal Food and …

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Variant Sequencing of SARS-CoV-2 Creates Opportunities for Labs

Clinical Laboratory / By Robert Michel

CEO SUMMARY: Variants of the COVID-19 virus are appearing across the world. Recent data show the same variants will infect people in several different countries. Here in the United States, interest is growing in having clinical laboratories sequence specimens from patients who test positive as a way to identify mutations and track their spread. Today, there is no reimbursement …

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Proscia Lands Major Deals as Digital Pathology Demand Grows

Digital Pathology / By Robert Michel

EVEN AS THE WORLDWIDE COVID-19 PANDEMIC DERAILED SOME INDUSTRIES, it gave a major boost to digital pathology. That has meant an expanding market for Proscia, a seven-year-old provider of digital and computational pathology solutions. Established in 2014, Proscia recently won what may be the world’s most important contract involving digital pathology and computational pathology solutions. On Oct. 20, 2020, it was announced …

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hc1, Visiun, and Viewics: Analytics Market Evolves

In Vitro Diagnostics / By Robert Michel

CEO SUMMARY: To understand any development in the marketplace, it is best to follow the money. That Roche, Quest Diagnostics, and LabCorp spent money either to purchase or partner with a lab analytics company in the past 36 months indicates that these enterprises believe acquiring or working with lab analytics systems can deliver competitive advantage. Labs began showing interest in real-time …

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February 8, 2021 Intelligence: Late-Breaking Lab News

Late Breaking Lab News / By Robert Michel

Pathologists and clinical lab managers with an entrepreneurial yen will be interested to know that Anthem, Inc., which serves 43 million beneficiaries, has launched a digital incubator. The new initiative was announced last month. Fierce Healthcare reported that the Anthem Digital Incubator (ADI) will “pair financial backing with mentorship and opportunities for partnerships with universities and others.” MORE ON: Anthem DI News reports say that ADI is accepting applications for community …

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