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...

Researchers Discover Links Between Non-Coding DNA and Cancer Growth That Could Lead to New Clinical Laboratory Biomarkers for Cancer and Other Chronic Diseases

Previously considered “junk,” scientists learn that parts of DNA which don’t produce proteins are more important than first thought It turns out that the long stretches of DNA in the human genome that are commonly called “junk DNA” or “dark DNA” may be doing important work. Researchers at the Ontario Institute for Cancer Research (OICR) recently published their findings about stretches of junk DNA that may have a role in how cancers develop. This is an area where pathology and omics are making...

Because of the COVID-19 Outbreak, AACC Reschedules Its Annual Conference to December in Chicago and Executive War College Reschedules Its Conference in New Orleans to July

Two major clinical laboratory conferences reschedule, as the SARS-CoV-2 pandemic continues to disrupt long-planned events; Many labs are losing money as fewer patients visit physicians This week, the ongoing Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) pandemic was responsible for two important developments in the clinical laboratory industry. Both involved the rescheduling of major annual conferences. In both cases, conference organizers are placing different bets on when they...

Chinese Firm to Replace Clinical Laboratory Test Kits After Spanish Health Authorities Report Tests from China’s Shenzen Bioeasy Were Only 30% Accurate

Bioeasy stands behind the accuracy of its coronavirus test kits and, in a statement, questioned whether they were being used correctly How accurate are the SARS-CoV-2 test kits being offered by different in vitro diagnostics companies, as well as the internally-developed COVID-19 tests developed by individual medical laboratories, both here in the United States and in other countries? It’s a question that has not been addressed by the news media nor by healthcare regulators. That is why a...

New Price Transparency Shopping Tools Help Healthcare Consumers Make Educated Choices and Save Money Using Smartphones and Other Devices

Price shopping for clinical laboratories and other healthcare services and surgical procedures creates a ‘healthy competitive environment,’ an Optum executive noted With the threat of infection from SARS-CoV-2 (the coronavirus that causes COVID-19) on the minds of most Americans, price transparency for medical care is more critical than ever, and new smartphone applications (apps) are helping patients shop for the best prices and quality when selecting healthcare, including clinical laboratory...

Clinical Laboratories Should Be Aware of Potential Airborne Transmission of SARS-CoV-2, the Coronavirus That Causes COVID-19

‘Aerosol and Surface Stability’ study shows that the virus can remain infectious in aerosol form for hours and on surfaces for days By now, clinical laboratory workers, microbiologists, and phlebotomists should be fully aware of the potential for transmission on surfaces of the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), the novel coronavirus that causes Coronavirus disease 2019 (COVID-19). The CDC’s latest Morbidity and Mortality Weekly Report revealed that the coronavirus...