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...

FDA Pushes Forward with Plans to Regulate Laboratory-Developed Tests, in a Move that Will Impact Many Clinical Laboratory Companies and Pathology Groups

It was national news when the FDA sent notice to Congress on July 31 that it planned to issue draft guidance on regulation of LDTs After sitting in a state of suspended animation for several years, the Food & Drug Administration’s (FDA) plans to regulate laboratory-developed tests are now front and center. On July 31, the FDA served the required 60-day legal notice to Congress that it was ready to move forward to issue rules for regulation of LDTs. If the federal agency wanted to get the...

International Telemedicine Gains Momentum, Opening New Markets for Pathologists and Other Specialists

Telemedicine allows U.S. pathologists and other specialists to boost revenue by consulting with international partners. Pathology laboratories in the United States are among the first adopters of a trend toward international telemedicine. Pathologists working at a handful of well-known healthcare organizations here in the United States are forming partnerships with other hospitals and health systems worldwide, particularly in China. Pathology Is Just One Medical Specialty Doing Global...

23andMe Submits Genetic Test Applications with the FDA

23andMe executives want the credibility that FDA clearance provides for its DNA tests and declared their intent to eventually support more clinical laboratory test applications Offering genetic tests directly to consumers is a controversial subject among some pathologists and healthcare ethics experts, who question both the science of these tests and whether consumers will do the right thing with the information. Now that debate is likely to heat up, because direct-to-consumer genetic testing...
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