Scientists Estimate 73% of US Population May Be Immune to SARS-CoV-2 Omicron Variant

Clinical laboratory scientists should also know experts warn that ‘herd resistance’ is more likely than ‘herd immunity’ due to low vaccination rates in many parts of the world Scientists estimate 73% of the US population may be immune to the SARS-CoV-2 omicron variant. Whether the nation is approaching “herd immunity” against the disease, however, remains open to debate, the Associated Press (AP) reported. These estimates are relevant to medical laboratories doing serology tests for COVID-19,...

Washington Post Investigation into CDC’s Failed Rollout of COVID-19 Tests Shows Federal Government’s Missteps and Miscalculations, Part One of Two

Previously unreported email messages and documents paint vivid picture of public health laboratory officials’ dismay and frustration over testing delays Between late January and early March, Clinical laboratory leaders watched with dismay as federal government missteps crippled the Centers for Disease Control and Prevention’s (CDC) rollout of its COVID-19 diagnostic testing in the early days of the pandemic. The resulting lack of testing capacity enabled the novel coronavirus’ spread across...

Biodiagnostic Laboratory Services Leaders Sentenced to Prison in $100-Million Lab Test Kickback Scheme That Also Led to Convictions of 38 Physicians

DOJ says now-defunct clinical laboratory in New Jersey generated test orders by bribing physicians with cash, concert tickets, vacations, high-end automobiles, and prostitutes  It finally happened! Two medical laboratory executives were given jail sentences for their role in the rampant fraud and abuse committed during the operation of Biodiagnostic Laboratory Services (BLS) of Parsippany, N.J. The court accepted their guilty pleas in 2015, but delayed sentencing until this year, because the...

CMS’s ‘Innovation Center’ May Be the Affordable Care Act’s Lasting Legacy, Particularly as It Works to Replace Fee-for-Service Payments with New Reimbursement Models

Clinical laboratories and pathology groups feel the impact of many of the Center’s demonstration projects that move healthcare toward value-based reimbursement One perennial criticism of this nation’s healthcare system is that it is slow to innovate. Technologies and management principals widely adopted by many industries may take a decade or longer to gain acceptance by hospitals, physicians, and clinical laboratories. To encourage faster adoption by useful technologies and innovations by...

23andMe Socked with FDA Warning Letter and Class Action Lawsuit over Company’s Genetic Testing Services

FDA’s assertion of power to regulate genetic tests is a familiar argument to pathologists and clinical laboratory scientists, but does create problems for 23andMe It has been national news since November 22, when the Food and Drug Administration (FDA) sent a letter to 23andMe ordering it to stop the sale of direct-to-consumer genetic tests. The FDA said that 23andMe had failed to prove the validity of its genetic tests and gave the company 15 days to respond and  identify the steps it would...
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