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Pandemic pressures continue to produce unprecedented action from the FDA. The current imperative is to clear assays and collection kits for rapid and easy screening, including products that can be used in home settings. A new barrier was crossed on April 6 when the agency granted Emergency Use Authorization (EUA) for a SARS-CoV-2 antibody detection test used in dried blood spot samples collected at home. The Symbiotica System The groundbreaking EUA went to Symbiotica’s COVID-19 Self-Collected Antibody Test System, a prescription-only test designed to detect immunoglobulin G against SARS-CoV-2 in dried blood spots obtained via fingerstick. The kit includes lancets that individuals can use to collect the blood samples themselves and mail to Symbiotica’s California lab for analysis. “The authorization of the first prescription use, home collection antibody test will… . . . read more
By Dan Scungio Many years ago, a woman purchased a cup of coffee in a restaurant drive-through. Not having a cup holder available in her car, she placed the cup between her legs to hold the coffee while she reached for money to pay for it. She burned her legs, sued the restaurant, and actually won her court case. Now such restaurants are required to warn customers with signs stating the obvious; “coffee served hot.” Before this regulation came to be, however, many people were aware of the possible danger of placing a hot cup near their skin. Does having a posted sign make customers safer? What about in a medical environment? There isn’t an explicit safety regulation written for every action that could create an unsafe situation. So, what… . . . read more
At-home COVID-19 testing and sample collection is becoming so big that it’s drawing players from outside the lab testing market. And it’s not just the Walgreens, Walmarts, Amazons and other retailers that have been established in the direct-to-consumer (DTC) diagnostics market well before the pandemic began. Among the most recent of the new arrivals to the DTC at-home COVID testing space is Uber. On April 26, the health care arm of the omnipresent rideshare company announced that it’s teaming up with Clinical Enterprise, Inc. d/b/a empowerDX, a US subsidiary of Luxembourg-based Eurofins Clinical Diagnostics, to provide on-demand delivery service of at-home COVID-19 testing kits to consumers. The empowerDX-Uber Collaboration empowerDX is an online shop affiliated with CLIA-certified clinical labs in the US that offers at-home testing for men’s and women’s… . . . read more
Fair or unfair, the general perception has been that the White House has been less than fully supportive of COVID-19 testing efforts during the pandemic. On Jan. 21, his first full day in office, President Biden released his plan to deal with the COVID-19 crisis. While vaccination takes center stage, the National Strategy for the COVID-19 Response and Pandemic Preparedness (National Strategy) emphasizes the importance of scaling and expanding testing by doing something the previous administration refused, namely, creating a centralized federal agency to “oversee implementation of a clear, unified approach to testing.” The 7 Objectives The National Strategy is organized around seven objectives: Restoring the trust of the American people; Mounting a safe, effective, and comprehensive vaccination campaign; Mitigating spread of the virus through the establishment of clear public… . . . read more
Early detection and early intervention have the potential to improve the prospects of recovery and positive outcomes for a broad range of diseases, including coronavirus. And now researchers in Europe believe they have found a method that uses a COVID-19 patient’s blood count to guide treatment and improve case outcomes. Here is an overview: The Diagnostic Challenge COVID-19 spans a wide clinical spectrum ranging from asymptomatic to severe pneumonia with multiple organ failure, and death. Early identification of critical patients requiring more aggressive intervention could go a long way in reducing COVID-19 deaths. But from almost the moment the pandemic began, the paramount objective of COVID-19 diagnostics has been to determine whether a person does or does not have the virus. Collecting information to guide medical treatment and improve clinical… . . . read more
Case: Labs like LabCorp typically enter “pass-through” arrangements with physicians covering patients that lack insurance or are otherwise self-pay. The way it works: The lab bills the physician who ordered the results. The physician then pays the bill and seeks reimbursement from the patient. Thus, the charges “pass through” the physician to the patient. LabCorp contends that this was the case with a New Mexico physician liable for $117,210 of unpaid charges on a pair of accounts. But the physician disagreed, claiming that the accounts were set up solely to facilitate billing for insured patients and that he had never agreed to pay for any services rendered to uninsured patients. So, he asked the federal court to dismiss the claim. Significance: The court refused. Even though the agreement didn’t… . . . read more
