While the world awaits a working vaccine to protect us from COVID-19, we need to employ all available tools to help curb the spread of this novel virus. On the one hand, it’s remarkable that we’re relying on the same low-tech tools that our forebears used to moderate the pandemic of 1918 — social isolation, mask-wearing and hand-washing. On the other, we have access to numerous technologies that hadn’t even been invented a century ago. Among the most important is molecular diagnostics for advanced testing.
While we continue to face a scarcity of test kits in the U.S., the majority of commercially available genetic tests for COVID-19 are reliable, so accuracy is rarely the problem. We’re hampered instead by the timeliness of getting the results and by the level of detail the tests provide.
To save more lives and reduce the burden on our healthcare system, we need point-of-care genetic tests that deliver accurate results rapidly, telling us right away who’s positive and who’s negative. We also need pertinent test data shared as quickly as possible via secure networks to improve our ability to track surges in infections. These are two of the challenges that emerging biotech companies are pivoting to embrace.
RT-PCR: The Gold Standard in Accuracy, Not Speed
When I read about some of the high-quality COVID-19 tests on the market – such as Abbott’s, which detects positive results in as little as five minutes — I am awed by how far we’ve come since the last global pandemic. The core enabling technology in test platforms such as Abbott’s uses the molecular genetics technique real-time reverse polymerase chain reaction (RT-PCR). The vast majority of rapid tests administered today in hospitals and other clinical settings use RT-PCR.
While accuracy is high for RT-PCR tests, getting tests results to patients is slow because test samples are sent to the lab for analysis. That lab could be located in a hospital, in a doctor’s office, or in an urgent care facility run by a large company such as Quest Diagnostics. Regardless of location, each lab must have an RT-PCR machine to read the test results. Plus each RT-PCR machine costs thousands of dollars, and requires a technician to read the results, , factors that have limited the proliferation of these machines.
New COVID-19 cases are still surging in parts of the U.S., India and Brazil, and in some areas, we’re seeing instances of inundated labs, with test results coming back in one to two weeks. That’s not fast enough for a virus this contagious. We need to get accurate tests results to healthcare providers, public officials, and patients as close to real-time as possible. To meet this goal, we need to apply molecular-diagnostic techniques to new types of biosensors that deliver test results at the point of care in minutes through platforms that send that data in near real-time to the cloud. This essential information will allow public health institutions, states, cities and other key stakeholders to identify and mitigate emerging hot spots of disease.
Over the past seven months, we’ve had the privilege of working with a handful of biotech companies that have pivoted to develop rapid point-of-care molecular diagnostics that target COVID-19. One of these, HEMEMICS, is developing a handheld molecular diagnostic test platform that could be administered by healthcare workers in triage settings such as ambulances, emergency rooms, community clinics and makeshift hospitals. As a true point-of-care test platform, it would deliver results onsite, without requiring the transfer of test samples to a lab.
“We’re aiming to redefine point-of-care testing for COVID-19,” said John Lehman Warden, Jr., CEO and co-founder, HEMEMICS. “Unlike the most common type of on-site test — the lateral flow monitor — our test isn’t waiting for osmotic reactions to occur. We place the sample from a quick nasal swab or a drop of blood right on-chip, and binding takes place within a standing drop of fluid. That makes our platform fast, delivering results in about 60 seconds. Plus it simplifies sharing test results with other communities of interest, such as public health departments and municipalities, because it’s Bluetooth-enabled and supports cloud-based management networks.”
As its foundry partner, we’re collaborating with HEMEMICS as it continues to refine its biochip’s sensitivity for both antibody and antigen testing of SARS-CoV-2. Once HEMEMICS is satisfied, it will move forward with the U.S. Food and Drug Administration’s (FDA’s) emergency use authorization (EUA), which it hopes will bring the HEMEMICS platform into the hands of the millions of people who stand to benefit.
As we head into the fall and winter months, we’ll need both rapid, connected point-of-care biosensor test platforms such as HEMEMICS’ and high-accuracy RT-PCR tests to fight COVID-19 effectively. And at their root, we’ll have MEMS and biosensors to thank.
As founder and CEO of Rogue Valley Microdevices, Jessica Gomez has created a world-class precision MEMS foundry in the heart of Southern Oregon. Integral to her role as CEO, Gomez practices a business philosophy of offering best-in-class process technology and R&D expertise to customers to help them achieve the highest quality and reliability in their products.
Gomez plays an active leadership role within and beyond the technology industry. She is a board member of the prestigious SEMI Board of Industry Leaders, she was the first executive selected for Spotlight on SEMI Women, and she is chairman of the Oregon Institute of Technology Board of Trustees.
Rogue Valley Microdevices is a longtime member of MEMS & Sensors Industry Group (MSIG), a SEMI technology community that enables the MEMS and sensor industry to address common challenges, innovate and accelerate business results.