Emerging Tests

Qiagen Launches Portable COVID-19 Antigen Digital Testing Hub

The rapid evolution of COVID-19 testing in response to the need for speed and mobility continues. One notable development on the antigen testing front is Qiagen’s U.S. rollout of a portable digital … [Read more...]

DTC

Research Supports Viability of Using Health Data from Consumer Wearables to Diagnose COVID-19

  That Fitbit, smartwatch or other device that many of us wear around our wrist to count our steps, calories burned and other fitness metrics on a daily basis may prove to be an ideal tool for … [Read more...]

Business Trends

Labs Partner with Airlines to Offer COVID-19 Testing to Travelers

civCOVID-19 has greatly complicated air travel from country to country and even state to state. While entrance rules vary from place to place, a number of jurisdictions are allowing travelers to avoid … [Read more...]

Point of Care

New Low-Cost Sensor Offers Promising Test for Rapid, At Home COVID-19 Testing

Laboratory companies and scientists are working furiously to produce the rapid, point of care testing technology needed to prevent asymptomatic people from spreading SARS-CoV-2. And in a promising new … [Read more...]

Public Health

Lack of Reporting, Not Tests, Is the Bar to Mass Utilization of COVID-19 Antigen Testing

Because of their low costs, scalability and speed, antigen tests may play a crucial role in meeting the unprecedented level of demand for point of care COVID-19 screening tests, particularly in … [Read more...]

HHS Announcement

The FDA Drops a Bombshell: No More EUA Review of COVID-19 LDTs

Perhaps one of the only positive things to come out of the COVID-19 crisis has been its exposure of the flaws in the FDA’s ham-handed system (if it can be called a system) of premarket regulation of … [Read more...]

Direct-To-Consumer

Walmart & Quest Provide Drone Delivery of At-Home COVID-19 Test Kits

The previous decade has seen the direct-to-consumer (DTC) diagnostics products business take quantum leaps forward thanks to collaborations between major lab companies and retail giants that enable … [Read more...]

Emerging Tests

New Initiative Seeks to Standardize SARS-CoV-2 Antibody Tests

When the pandemic began, antibody testing was looked to as the kind of ace in the hole that would not only resolve the COVID-19 testing shortage fast and for good but also pave the way for society to … [Read more...]

COVID-19

New Study Shows Saliva-Based SARS-CoV-2 Test to Be at Least as Accurate as Swab Tests

Saliva-based tests could go a long way in relieving the supplies shortages that have hampered COVID-19 testing efforts. The question, though, is whether saliva samples yield results as accurate as … [Read more...]

Technology

CMS Proposes Clarified Medicare Coverage “Reasonable and Necessary” Criteria for Breakthrough Devices

On Sept. 1, CMS proposed a new rule that would, among other things, shed some light on an issue that has been a perennial compliance and reimbursement stumbling block for developers of new lab tests: … [Read more...]


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