Can Consumers Collect Their Own Biological Specimens for Direct-to-Consumer SARS-CoV-2 Tests? FDA Says ‘No’ to Clinical Labs Announcing Such Tests

Following criticism over delays in authorizing medical LDT COVID-19 tests, the FDA swiftly shut down consumer at-home specimen collection schemes Banning COVID-19 tests that rely on consumers’ collecting their own specimens at home is one example where the federal US Food and Drug Administration (FDA) took remarkably swift action. It’s also interesting to note how some business people—who lack formal training in clinical laboratory medicine—often are ready to seize any opportunity to sell lab...

Internationally-respected Experts in Clinical Pathology and Laboratory Medicine Ask: Why Don’t We Know More about Theranos’ Technology?

This secretive start-up medical laboratory testing company has not disclosed how its diagnostic test technology works, nor has it given laboratorians an opportunity to examine the technology Several internationally-respected clinical laboratory experts are asking serious questions about Theranos and its diagnostic testing technology, and they’ve gotten few answers to date. Though the number of experts is small, their credentials in the clinical laboratory profession are impressive. In...

New Microfluidic Blood-draw Device Could Replace Needle Sticks and Venipunctures at Medical Laboratories

By placing this low-cost, disposable device developed at the University of Wisconsin-Madison on their arms or abdomens, patients can collect their own blood at home in minutes For more than two years, the nation’s media have been captivated by Theranos CEO Elizabeth Holmes’ vision of offering patients who need blood tests a finger stick collection instead of a venipuncture. Meanwhile, in research labs across the nation, there are credible efforts to develop ways to collect medical laboratory...

Company’s Goal Is to Reduce Consumer’s Need to Visit Clinical Laboratories by Developing a Test Device for Home Monitoring of Fitness and Pre-Existing Conditions

Flow Health Hub device could be disruptive to medical laboratories, as it will be designed to allow patients to perform their own diagnostic tests to monitor pre-existing conditions Another biotech company has its eye on medical laboratory testing and wants to bring to market what it describes as a consumer do-it-yourself test device. The company is designing the device to let consumers do fitness monitoring. But it hopes the device will also allow consumers to monitor pre-existing conditions...

Geneticist at University of California Davis Sequences His Unborn Baby’s DNA in a Global First for Whole Genome Sequencing

Prenatal genome sequencing raises ethical issues for gene sequencing labs and clinical labs, since a baby’s genetic information may present lifelong consequences for that individual Pathologists and clinical laboratory managers will be interested to learn that another milestone in genetic testing was reached earlier this year. A geneticist at the University of California at Davis, has sequenced the whole human genome of his unborn baby, the first time this feat has been accomplished. Notably,...
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