TAG:
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…
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…
COVID-19 or Not, Lab Market Enters ‘Twilight Zone’
Our healthcare system is in a most remarkable state. Even as all providers—including clinical laboratories and anatomic pathology groups—continue to devote considerable resources to meeting the urgent need for SARS-CoV-2 testing, health insurers and regulators continue to issue new requirements g…
California Builds Its Own COVID Lab: $25 Million or $1.7 Billion?
CEO SUMMARY: California dropped a bomb on the state’s 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…
Medicare COVID Test Coding May Become a ‘Logistical Nightmare’
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…
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…
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…
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…
CURRENT ISSUE
Volume XXXI, No. 5 – April 8, 2024
The fragmentation of consumer markets is reflected in clinical lab services, and The Dark Report examines this trend and how it will impact labs in the coming years. Also, The Dark Report notes that the FDA has issued a controversial memo to reclassify many high-risk IVD assays.
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