Labcorp and Quest Discuss Outreach Acquisition Potential

By Scott Wallask | From the Volume XXX, No. 14 – October 2, 2023 Issue

GIVEN THE POTENTIAL UPSIDE OF HUNDREDS OF MILLIONS OF DOLLARS IN ADDED REVENUES, both Labcorp and Quest Diagnostics remain on the prowl to acquire more hospital laboratory outreach …

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IVD Companies Launch New Assays, Analyzers, Automation

By Donna Marie Pocius | From the Volume XXX, No. 12 – August 21, 2023 Issue

Steep declines in SARS-CoV-2 test revenue were reported by the top in vitro diagnostics (IVD) companies in Q2 2023 earnings compared to a year earli…

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Pharmacogenetic Tests Deliver for Avera Health Lab

By Scott Wallask | From the Volume XXX, No. 6 – April 17, 2023 Issue

CEO SUMMARY: When Avera Institute for Human Genetics wanted to expand its genomics program, it used its past learning with pharmacogenetics to guide the effort. Two key insights? Ask physicians abo…

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CLIA on Path to Recognize Lab Data As a Specimen

By Scott Wallask | From the Volume XXX No. 2 – January 23, 2023 Issue

CEO SUMMARY: Discussions within the federal Clinical Laboratory Improvement Advisory Committee (CLIAC) are focusing on digital diagnostic data and clinical laboratory testing conducted remotely. CLIAC recommendations about these important topics may eventually be part of updates to …

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Eight Macro Trends for Clinical Labs in 2023

By Robert Michel | From the Volume XXX, No. 1 – January 3, 2023 Issue

CEO SUMMARY: Laboratory administrators and pathologists will want to carefully study eight important trends that will guide their business strategies in 2023. Many of these macro trends center on financial and operational difficulties and ways to steer around these obstacles. Anothe…

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Newsmaker Interview: Director of CDC’s Division of Laboratory Systems Talks COVID-19, CLIA, and More

By Robert Michel | From the Volume XXIX, No. 15 – October 31, 2022 Issue

CEO SUMMARY: In this exclusive interview, Reynolds Salerno, PhD, the Director of the Division of Laboratory Systems at the CDC, offers insightful comments about the federal agency’s response to the SARS-CoV-2 pandemic, what went right during public health efforts, and lesson…

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January 31, 2022 Intelligence: Late-Breaking Lab News

By Robert Michel | From the Volume XXIX, No. 2 – January 31, 2022 Issue

DNA-based breast cancer testing is taking a step forward. Illumina in San Diego, which sells next-generation sequencing (NGS) technology, announced a partnership with Agendia in Irvine, Calif., to develop in vitro diagnostic tests for oncology. Agendia offers proprietary breast …

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Payers Continue to Increase Coverage of Liquid Biopsies

By Robert Michel | From the Volume XXVIII, No. 17 – December 20, 2021 Issue

SINCE THE FIRST BLOOD-BASED, circulating-tumor DNA (ctDNA) sequencing test for cancer became available in 2014, federal and private payer coverage of these so-called “liquid biopsy” tests has increased substantially. Now, clinical laboratory and pathology directors can expect additional coverage …

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India’s Neuberg Diagnostics Expands into U.S. Market

By Robert Michel | From the Volume XXVIII, No. 11 – August 16, 2021 Issue

“Our idea is to enhance the access and affordability for next-generation techniques, meaning molecular diagnostics, genomics, pathology, digital pathology, proteomics, metabolomics, and all that. This is the spirit behind Neuberg Diagnostics. —GSK Velu, PhD, BPharm …

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Response to FDA’s Gottlieb on Reducing Regulatory Burden

By Joseph Burns | From the Volume XXV No. 6 – April 16, 2018 Issue

IN PREPARED REMARKS at a clinical lab industry meeting last month, FDA Commissioner Scott Gottlieb, MD, outlined steps the federal Food and Drug Administration would take to reduce the regulatory burden on labs that develop next-generation gene sequencing and lab-developed tests. He …

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