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lab testing services

Lab Buys More Instruments as Way to Add Test Volume

CEO SUMMARY: Severe shortages of supplies for COVID-19 lab testing caused one lab director in the Midwest to buy additional instruments while also validating five different COVID-19 tests to run on analyzers the lab used before the pandemic hit. While this strategy allowed the lab to …

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June 22, 2020 Intelligence: Late-Breaking Lab News

As they scramble to respond to the COVID-19 pandemic, federal officials in multiple agencies are purchasing equipment and supplies from vendors with dubious credentials and little operating history. In recent days, Pro-Publica reported “a fledgling Texas company was paid $7.3 mil…

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COVID-19 Pandemic Erodes Cash Flow at Clinical Labs

CEO SUMMARY: Every day, national news headlines scream about the shortage of SARS-CoV-2 lab tests needed to manage the COVID-19 pandemic. Recently, national news coverage has begun focusing on concerns about inaccurate or unreliable COVID-19 serology tests. But the story being…

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Coronavirus Tests Boost Immunology Lab’s Volume

CEO SUMMARY: Physicians treating patients with compromised immune systems who contract the new coronavirus need immunology tests to guide risk-assessment decisions for these patients. At a Virginia lab that specializes in such testing, specimen volume has tripled since the SAR…

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In Michigan, Short Supplies Constrain COVID Test Capacity

CEO SUMMARY: Because of a severe shortage of supplies, members of Michigan’s two hospital laboratory networks have been stymied in their ability to respond to the pandemic and operate their SARS-CoV-2 analyzers at full capacity. The lack of primers, reagents, specimen-collec…

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Lab Directors Develop Plans for Return of Routine Hospital Care

CLINICAL LABORATORY DIRECTORS IN MICHIGAN are developing plans to test patients who will return when hospitals reopen for routine care. Included in those plans are strategies to do testing for the novel coronavirus on patients who will return for everyday care and elective procedures, said Bart…

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June 1, 2020 Intelligence: Late-Breaking Lab News

Daily, national news headlines call attention to the lack of adequate testing for COVID-19. News reporters question why clinical labs are unable to meet the demand for SARS-CoV-2 tests. One major reason is the lack of adequate supplies labs need to collect specimens, transport them, and per…

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March, April Patient Visits Drop at Virginia Physician Group and Lab

DURING THE CARONAVIRUS PANDEMIC, gastroenterology and other physician groups with in-house medical laboratories—like most medical practices and clinical laboratories in the United States—have seen a sharp drop in patient visits and specimen volume. That drop occurred at the same time ga…

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FDA Replaces March 16 Serology COVID-19 Rules

CEO SUMMARY: In the rush to allow companies and clinical laboratories to develop, validate, and bring to market serological tests for COVID-19, the federal Food and Drug Administration issued rules on March 16 that eased its requirements for these new assays. Because of the la…

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Expert Offers Comments on FDA and Revised Serology Test Rules

CLINICAL LABORATORY DIRECTORS are asking what caused the federal Food and Drug Administration (FDA) to issue a highly questionable policy in March to allow serological tests for SARS-CoV-2 and then change that policy seven weeks later. Under a policy the agency issued March…

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