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Top Stories of 2020: Regulatory Landscape, Emergency Use Authorization, Organs-On-A-Chip. And COVID-19

December 29, 2020 | By March, the whole world was faced with a massive diagnostics problem—pushing “PCR”, “antigen tests”, “sensitivity”, and “EUA” to the forefront of public conversation. Diagnostics companies, hospitals, and even outside computer programmers all pivoted to focus on methods for diagnosing SARS-CoV-2 infections quickly, accurately, and with a test that could scale. For Diagnostics World News, our COVID-19 stories were—understandably—our most watched coverage. We began posting weekly literature roundups on Fridays early in the pandemic and those roundups alone are a fascinating capsule of our growing understanding of how to diagnosis infections, and track how the virus moves. 

But COVID-19 diagnoses weren’t the year’s only developments. We also covered the growing trends in medical monitoring, organ-on-a-chip models, the regulatory environment for laboratory-developed tests and much more. —The Editors

Co-Diagnostics Presents Rapid Diagnostic Test For Coronavirus In San Francisco: Co-Diagnostics came out early in the race to create a rapid diagnostic test for COVID-19. Live from the Molecular Medicine TriConference, the Salt Lake City diagnostics company reported how their CoPrimer system could be applied to SARS-CoV-2. 

NIH Launches RADx: Billion Dollar Funding Initiative To Expand COVID-19 Tests By Fall: In an effort to further fuel the race for tests, National Institutes of Health announced the Rapid Acceleration of Diagnostics (RADx) initiative—fueled by $1.5 billion from the federal stimulus funding—to infuse funding into early innovative technologies to speed development of rapid and widely accessible COVID-19 testing. 

Three Types Of COVID-19 Tests Needed For Return To Normalcy: BloodPAC, a consortium managed by the nonprofit Center for Computational Science Research, outlined the three types of tests the world needs to move past COVID-19: symptomatic molecular testing, asymptomatic screening and next generation sequencing (NGS). A three-pronged approach is the only way to quickly identify infections and stop the spread of the virus. 

Human Longevity Inc. Changing Healthcare ‘One Patient At A Time’: HLI’s Health Nucleus is both a decision health platform driven by artificial intelligence (AI) and a bricks-and-mortar precision health wellness space in San Diego, California, that offers multimodal, data-driven assessments of clients’ current condition and future risk of chronic, age-related diseases. It’s a model HLI believes will change healthcare—one $7,500 package at a time.

Organ-On-A-Chip Model For Monitoring Side Effects Of Chemotherapy: Predicting the impact of chemotherapy on a sick cancer patient can be tricky, but researchers from the Terasaki Institute for Biomedical Innovation created an organ-on-a-chip model that can accurately measure the effects of a chemotherapeutic on breast cancer tissue and simultaneously identify the unintended side effects on healthy heart tissue.

Bacterial, Viral, or Neither? Host Response Test Has Answers: A Duke University team created a test that can distinguish between viral and bacterial infections—a non-trivial question essential to medical care. The test was developed as part of NIH’s Antimicrobial Resistance Diagnostic Challenge.

Zoom and Skype Rule Telemedicine World of Physicians: When most US hospitals suspended elective medical procedures and checkups, medical care shifted to telemedicine. Healthcare providers were left figuring out the best platforms to reach their patients and how to ensure that a virtual visit delivered actual care.

HHS Rescinds FDA’s Role in Regulating Lab-Developed Tests: After years of uncertainty over the future of laboratory developed tests, the Department of Health and Human Services determined this summer that the FDA does not have the authority to regulate lab-developed tests. At that point, thirty-five LDTs have been granted emergency use authorization for testing for SARS-CoV-2 infections. The rescission removed the need to submit those and other tests to FDA. 

CRISPR's Future For Point-Of-Care Diagnostics: In a conversation with Christina Lingham, executive director of conferences for the Diagnostics Innovation Summit, Can Dincer, from the University of Freiburg in Germany, outlined the obstacles facing point-of-care testing and how CRISPR may solve its challenges.

Rules of the Regulatory Road For Companion Diagnostics: The 12th Annual Next Generation Dx Summit was held virtually, allowing multiple speakers from FDA and pharma to gather to discuss the regulatory future of companion diagnostics and provide insights into CDx devices, how trials should be structured, and the outlook for increasingly complex tests like molecular genetic tests.  

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