South Korean Telecommunications Partner with Direct-to-Consumer Genetic Testing Companies to Send Test Results to Consumers’ Mobile Devices

As consumer demand increases for medical laboratory testing services that bypass the supervision of primary care doctors, clinical laboratories may be affected Direct-to-consumer (DTC) genetic testing organizations and telecommunications companies in South Korea are collaborating to help consumers stay informed of their health status by sending lab test results directly to their mobile devices without requiring physician involvement. What can labs in the West learn from these developments? One...

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...

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