CDC Announces Presence of Rare, Tropical Illness in Three Non-adjacent States and Genetic Testing Indicates There May Be a Common Source of Exposure

Microbiologists will want to take note of the CDC’s statement that the illness can masquerade as other diseases It is the latest example of a bacterium uncommon in the United States that has infected patients in this country—one of whom has died. The three infected patients live in separate states, but genetic analysis indicates their cases may be related. Microbiologists and clinical laboratory managers may want to read the recent official health advisory from the Centers for Disease Control...

On-demand Video Service Hulu Gets Underway on TV Miniseries Documenting Rise and Fall of Former Theranos CEO Elizabeth Holmes

Six-episode show is based on popular ABC Radio podcast “The Dropout,” which focused on the three-year investigation that brought down clinical laboratory test developer Theranos While former Theranos CEO Elizabeth Holmes awaits the start of her August 31 criminal fraud trial in a federal court in Northern California, one streaming video service is lining up a star-studded cast to tell the story of the Silicon Valley executive’s fall from grace and the demise of her clinical laboratory...

Cancer Researchers Use Astronomy Analysis Algorithms to Develop Platform for Locating and Examining Predictive Biomarkers in Tumors

Yet another example that technologies from non-medical fields continue to find their way into anatomic pathology and clinical laboratory medicine Anatomic pathologists and medical laboratory scientists may soon have new tools in the fight against cancer, thanks to researchers at the Mark Foundation Center for Advanced Genomics and Imaging at Johns Hopkins University and Bloomberg-Kimmel Institute for Cancer Immunotherapy. Using algorithmic technology designed for mapping the stars, the...

Penn Medicine Researchers Develop Fast, Accurate, Inexpensive COVID-19 Diagnostic Test Based on Electrochemical Technology

The rapid diagnostic test costs less than $5 per unit and can be adapted for other diseases, the developers say, which opens a slew of possibilities for clinical laboratories Just as the SARS-CoV-2 coronavirus spurred deployment of new vaccine technology based on messenger RNA (mRNA), the COVID-19 pandemic also could prove to be a watershed for in vitro diagnostics (IVD) innovation in ways that benefit clinical laboratories. In one notable example, researchers at the Perelman School of...

FDA Grants CLIA Waiver Allowing First Test for Chlamydia and Gonorrhea to Be Performed at the Point of Care

Federal regulators continue to recognize value of clinical laboratory testing in near-patient settings To help in the diagnosis and management of two sexually-transmitted diseases, another point-of-care diagnostic test will soon be available for use in physician’s offices, urgent care clinics, and other healthcare settings. The federal Food and Drug Administration (FDA) announced it granted a CLIA waiver for the binx health io CT/NG assay, a molecular platform used to detect sexually...

COVID-19 Surveillance Screening Program Used in Chicago School Systems Comes Under Scrutiny by Illinois Department of Public Health Following New York Times Article

Dozens of Chicago-area schools were reopened with the help of an $11 COVID-19 saliva test, but the qualifications of the clinical laboratory, and whether it complied with federal regulations, were called into question It was only a matter of time when newly-formed clinical laboratories—taking advantage of the federal government’s loosening of regulations to promote COVID-19 testing—drew the attention of state regulators and the national news media. This is what happened at New Trier High...
;