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


COVID-10 testing

Academic, Commercial Collaboration for Testing

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, t…

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

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 s…

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COVID-19 or Not, Lab Market Enters ‚ÄėTwilight Zone‚Äô

Our healthcare system is in a most remarkable state. Even as all providers‚ÄĒincluding clinical laboratories and anatomic pathology groups‚ÄĒcontinue to devote considerable resources to meeting the urgent need for SARS-CoV-2 testing, health insurers and regulators continue to issue new requirements g…

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California Builds Its Own COVID Lab: $25 Million or $1.7 Billion?

CEO SUMMARY: California dropped a bomb on the state‚Äôs existing network of hospital labs and independent clinical labs when, on Oct. 30, it announced it had built and opened a new laboratory facility in Valencia designed to perform 150,000 COVID-19 tests per day. Now, existing labs…

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Medicare COVID Test Coding May Become a ‚ÄėLogistical Nightmare‚Äô

STARTING JAN. 1, 2021, clinical laboratories performing COVID-19 tests using high-throughput systems for Medicare patients must comply with a complex new coding rule when submitting claims for these tests.¬† The federal Centers for Med…

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Labs Still Confront New Supply Shortages Daily

CEO SUMMARY: For three lab directors in the Midwest, a¬†seemingly endless cycle of COVID-19 lab-supply shortages crops¬†up almost daily. These labs might not have enough test kits one¬†day, and be short of reagents, transport vials, or specimen collection¬†swabs the next. To address these…

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July 13, 2020 Intelligence: Late-Breaking Lab News

On July 9, eight national¬†laboratory associations¬†sent a letter to Vice¬†President Mike Pence to¬†request that the White House¬†Coronavirus Task Force¬†take action to resolve major¬†obstacles that constrain the¬†ability of their member laboratories to perform molecular¬†and serological tests for¬†C…

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Where Is the FDA When Labs Need It Most?

LET’S START WITH AN ESSENTIAL FACT: in the management of almost every¬†outbreak of a novel infectious disease, clinical laboratory tests will be essential¬†in diagnosis of the disease, in monitoring the progress of an infected patient,¬†and in determining if, once cured, a patient has immunity to tha…

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