New Class of IVD Firms Wants to Serve POCT in Near-Patient Settings

By Robert Michel | From the Volume XXVIII, No. 13 – September 27, 2021 Issue

CEO SUMMARY: Our second installment in this series describes an emerging new clas…

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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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Dartmouth-Hitchcock Builds Strong Lab Outreach Business

By Joseph Burns | From the Volume XXV No. 10 – July 9, 2018 Issue

CEO SUMMARY: As health networks and hospitals consider outsourcing their lab outreach programs, the lab team at Dartmouth-Hitchcock Medical Center (D-H) offers lessons about the value of retaining outreach. D-H is now in the eighth year of a sustained expansion of its laboratory outreach …

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Wake Forest Baptist Lab’s Path Errors Teach Lessons

By Joseph Burns | From the Volume XXV No. 7 – May 7, 2018 Issue

CEO SUMMARY: For medical directors and pathologists interested in improving their labs’ compliance with CLIA regulations, a report from federal and state inspectors of an inspection of the pathology lab at the Wake Forest Baptist Medical Center offers insights into what issues caught th…

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After Two Decades, CMS Wants to Update CLIA Lab Regulations

By Joseph Burns | From the Volume XXV No. 2 – January 22, 2018 Issue

IN THE FIRST EFFORT OF ITS kIND in more than two decades, the federal Centers for Medicare and Medicaid Services has published a request for information (RFI) in the Federal Register as a first step to revise the CLIA rules it promulgated in 1992. Over the years, CMS has made some m…

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Lab Executives Declare Concerns about Fee Cuts

By Joseph Burns | From the Volume XXV No. 1 – January 2, 2018 Issue

CEO SUMMARY: Members of Joint Venture Hospital Laboratories in Michigan anticipate that the 2018 Clinical Laboratory Fee Schedule rates being implemented under PAMA will lower payment from Medicare to less than the cost of running tests, especially for rural and critical access hospitals….

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China Invests $9 Billion In Precision Medicine

By Joseph Burns | From the Volume XXIV No. 1 – January 9, 2017 Issue

CEO SUMMARY: In the 1960s, it was a race to be first in space between the United States and the Soviet Union. This decade, it’s a race to be first in genetic and precision medicine between the U.S. and China. To that end, the Chinese government has budgeted $9 billion as an investment t…

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Achieving CLIA, ISO 15189 at Same Time with A2LA

By Joseph Burns | From the Volume XXII No. 3 – February 17, 2015 Issue

CEO SUMMARY: An interesting milestone for the clinical lab industry is on the horizon. Physicians Choice Laboratory Services in South Carolina will soon become one of the first lab organizations in the United States to earn joint CLIA and ISO 15189 accreditations with the America…

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Why One Molecular Diagnostics Company Closed Its Doors

By Joseph Burns | From the Volume XX No. 7 – May 28, 2013 Issue

CEO SUMMARY: When executives closed the doors of Pathwork Diagnostics last month, the simple explanation was that reimbursement for its proprietary molecular diagnostic test was inadequate. Indeed, that was part of the story. But other factors played significant roles in impeding…

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Third Laboratory Earns ISO 15189 Accreditation

By Robert Michel | From the Volume XVI No. 12 – August 31, 2009 Issue

CEO SUMMARY: In June, the laboratory at Blanchard Valley Hospital became third in the nation to be accredited to ISO 15189:2007. The 150-bed acute facility in Findlay, Ohio, is the only hospital laboratory of its size to achieve accreditation to the ISO 15189 standard. Implementi…

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