via fiercebiotech
In response to the coronavirus crisis, we’ve seen COVID-19 diagnostics quickly evolve from early, multistep kits to high-throughput versions to fast point-of-care tests, all in just a few weeks. Now, the FDA has granted an emergency authorization to a device that fits in the palm of your hand.
Mesa Biotech’s Accula device is designed to enable near-patient testing, available anywhere outside of the laboratory, with results in about 30 minutes.
Based on the company’s previous tests for influenza and respiratory syncytial virus, the compact diagnostic is aimed at temporary coronavirus screening sites, urgent care locations and long-term nursing facilities as well as small physician-run labs.
“This allows many units to be run side-by-side in the doctor’s office, further increasing the speed of COVID-19 diagnosis,” said Hong Cai, co-founder and CEO of Mesa Biotech, which plans to begin shipping the test in the U.S. immediately. “Accula provides a true decentralized testing solution for COVID-19 at the point of care.”
“Our test will provide a highly accessible means for healthcare professionals to access laboratory quality results close in their office to aid in the decision to isolate, treat or dismiss potential carriers of the virus,” Cai said in a statement, describing the system as a complement to centralized high-throughput testing. “The potential to reduce the growing strain on our nation’s hospitals is tremendous.”
The platform—employing a visually read PCR test using nasal and throat swabs—was developed with global epidemics in mind, with funding from the National Institutes of Health’s National Institute of Allergy and Infectious Diseases and the Western Regional Center of Excellence for Biodefense and Emerging Infectious Disease program, as well as through the Los Alamos National Lab.
Also: FDA will allow doctors to treat critically ill coronavirus patients with blood from survivors.
By massively scaling up two types of tests—PCR tests that detect the active presence of virus and serology tests that detect immune system responses to being infected by the virus—population screening could identify those who are currently infected and those who have recovered and are likely not to pass along the virus to others. Those who are currently infected could be isolated and their contacts traced so that they could quarantine themselves. Frequent large-scale testing of the uninfected would also help keep the epidemic in check by enabling them to withdraw if they subsequently contract the virus for a period of self-isolation in a timely fashion. Frontline health care providers and especially hard-hit regions should be given first priority as the testing regime begins its rapid expansion.
Those who had recovered from infection (possibly numbering ten times more than those whose symptoms drive them to seek out medical care) could help on the frontlines of the fight against COVID-19, return to work, and enjoy the pleasures of social life, e.g., dining out, meeting friends at bars, traveling, and attending performances at entertainment venues. “To make this strategy work, governments would need to involve employers, social organizations, schools and large retailers to conduct tests and provide time-stamped certifications,” propose the three researchers.
To ramp up both kinds of testing, the researchers urge that every laboratory capable of running PCR tests be pressed into service recruiting technicians, graduate students, and scientists to run the machines. Even better, Mesa Biotech just announced today that it has received Emergency Use Authorization from the Food and Drug Administration (FDA) to roll out its point-of-use 30-minute PCR test for the virus. Other companies should be encouraged to provide such tests.
As I also argued last week, the researchers argue that widespread deployment of serology tests for the presence of antibodies to coronavirus needs to be prioritized. This would identify people who had recovered and could safely go back to life outside of lockdown. Over at the Wall Street Journal, the perspicacious former FDA commissioner Scott Gottlieb also recommends massively scaling up serological surveillance. When population screening reveals that “a sizable portion of a local community has some protection, authorities can be more confident in relying on less invasive measures. Once deployed, serological tests are cheap, straightforward, and easy to scale.”
Several companies have already developed such tests.
Faster, please.
h/t GR