point of care diagnostics

COVID-19 has had an impact on the entire healthcare market. During the peak of the first wave, companies from the industrial and automotive sectors worked on repurposing their sensors and production lines to provide pressure sensors for respirators and temperature sensors for thermometers. At the same time, companies making sensors for wearables and other mobile devices used for remote monitoring of patients experienced saw increased demand, caused in part by the surge in telemedicine worldwide. In addition, strong demand for COVID-19 tests pushed diagnostic players to repurpose existing systems to detect the SARS-CoV-2 virus or associated antibodies. Over the past six months in particular, numerous microfluidic technologies have enabled either rapid point-of-care tests or high-throughput solutions for central labs. The demand for these tests is incredibly high (millions of tests per month are needed), which has contributed to boosting the revenue of many companies in the respiratory-testing area.These respiratory-testing companies have placed many testing machines at existing and new customer sites, and have sold an impressive number of test kits resulting in an initial revenue spike in Q1 2020, and even higher spikes in Q2 and Q3. This growth seems on track to last into early 2021 and beyond as the pandemic continues, the flu season arrives, and health organizations test increasingly higher numbers of people than they were several months ago. The winners in respiratory testing include Abbott, bioMérieux, Cepheid, GenMark and Luminex, among many others. In this context, Yole expects the point-of-care segment of the microfluidic product market to enjoy an impressive jump from US$4.5 billion in 2019 to US$6.3 billion in 2020, growing at 15.1% CAGR between 2019 and 2025 to reach $10.4 billion in 2025. This represents 40% of the total microfluidic product market in 2019.In its research on microfluidics, Yole tracks a wide range of COVID-19 tests from different companies. The tests are used to meet different needs. Evolution of COVID-19 TestingNo doubt this increased production of tests will be especially useful for the upcoming flu season. But what will happen next year, if (we hope) reliable COVID-19 vaccines are validated and marketed, and the new coronavirus eventually disappears? Will diagnostic companies’ sales fall to pre-pandemic levels, and all these investments in production lines be wasted? Don’t worry. This is not a one-shot deal: Once the pandemic is over, most testing machines will remain in place, and customers will use them to run other tests the companies offer – usually for other kind of infectious diseases – driving sales of single-use disposables in coming years. The pandemic has shown us that more efficient diagnostic tools are required. Rapid, inexpensive, widely accessible testing for infectious diseases is crucial if we are to face such challenging situations. The real struggle for diagnostic companies, especially in the field of microfluidics where recent platforms have a small assay menu, is placing instruments (i.e., the test machines that run the disposable cartridges and read the results) at customers’ locations, from hospital settings and urgent care to field testing sites, and this has now been achieved. This will drive consumables sales in the future, even beyond the pandemic, and take the microfluidic-based point-of-care testing market to the next level. Rapid point-of-care testing is driving growth in microfluidics and will continue to do so for years to come. In the meantime, new significant opportunities are opening for point-of-care diagnostic test-makers, and rapid, miniaturized microfluidic technologies may be the winners here. Rapid passenger screening in airports, and rapid employee or visitor screening at the workplace will become essential for preventing the virus’ spread. In total, this could represent billions of rapid tests needed per year. COVID-19 has slowed down business growth in many areas but has really helped microfluidic-based point-of-care diagnostics take it to the next level, and this is only the beginning.For more information on Yole’s microfluidics activities, please view Yole’s reports, Point of Need 2020 – Including PCR-Based Testing or Status of Microfluidics Industry 2020 or visit i-Micronews.comYole Développement is a member of SEMI and the MEMS Sensors Industry Group (MSIG), a SEMI technology community that connects the MEMS and sensors supply network in established and emerging markets enabling members to grow and prosper. Visit us today. Sébastien Clerc is a technology and market analyst in Microfluidics, Sensing Actuating at Yole Développement (Yole). As part of the Photonics Sensing team, Clerc has authored a collection of market and technology reports dedicated to microfluidics and other micro-devices for major market segments: medical (including diagnostics, pharmaceutical, biotechnology, drug delivery, medical devices) and industrial (including environment, agro-food). At the same time, he is involved in custom projects such as strategic marketing, technology scouting, and technology evaluation to help academic and industrial players in their innovation processes. Thanks to his technology and market expertise, Clerc has spoken in more than 20 industry conferences worldwide over the last four years. Clerc holds a master’s degree in Biomedical Technologies and a master’s degree in Innovation and Technology Management, both from Grenoble Institute of Technology (Grenoble INP - Grenoble, France).

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 SpeedWhen 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. For more information on Rogue Valley Microdevices’ biosensor solutions, please contact the company at [email protected] or visit its website. 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.

If you bought a new car recently, you must have noticed that it warns you if one of its functions needs your attention. It even alerts the factory if repairs or major adjustments are needed. Wouldn’t it be nice to have similar capabilities for our bodies that will call for a “service” before we end up in an emergency room – or worse? The United States invests almost 18 percent of its Gross Domestic Product (GDP) in healthcare. Such a significant part of our economy deserves our industry’s attention – and it gets it. SEMI’s recent Smart MedTech webinar series tells not only patients and healthcare providers how electronic products can impact their lives, but also offers device makers plenty of ideas for developing new solutions.SEMI Gets SmartIn addition to working on many important topics with more than 2,200 member companies across the semiconductor supply chain, SEMI focuses on special areas: Smart Mobility (as covered here), Smart MedTech (covered below), Smart Manufacturing, and Smart Data. Smart MedTech was the topic of four recent webinars, organized by Melissa Grupen-Shemansky, executive director Nano-Bio Materials Consortium (NBMC), and Chief Technology Officer, SEMI. NBMC’s mission is to enable flexible, wearable human performance monitoring. In her introduction, she emphasized that healthcare will shift from today’s provider-centric approach to a personalized care model, with the following characteristics: Outcome-based Decentralized, not limited to geographies Specific to your personal health and medical needs With a team of providers, connected like never before To achieve all these characteristics, microelectronics will be an essential contributor. That is why SEMI and member companies are working on platforms to fund and commercialize R D as well as to educate potential users and beneficiaries. Grupen-Shemansky engaged a series of experts and organized four webinars to address this broad and complex field, and outline their contributions to meeting the above criteria. They have been recorded and are available to SEMI members. Call your SEMI contacts to find out where and how you can access slides and recordings of more than a dozen presentations.From Biomarkers to BioChemical Sensors Physiological RelevancyTo monitor a human body’s performance, researchers have to first understand which biomarkers indicate specific conditions of the body, then learn how to capture and process the data. Grupen-Shemansky moderated this August 5th session. Christina Davis from UC Davis, Jennifer Martin, and Sean Harshman from the Air Force Research Lab (AFRL), and Kenneth Ward from Pacific Diabetes Technologies presented their ongoing efforts in this field.Davis talked about the challenges of analyzing exhaled breath, which contains 99% water and 1% biomarkers. She showed a hand-held analyzer her team has developed (Figure 1). She also elaborated on how to interpret the captured data and, if needed, decide which follow-up treatments are advised.Figure 1: Palm-sized µCON exhaled breath micro-condenser used to analyze biomarkers. (Courtesy: UC Davis) AFRL’s Martin and Harshman outlined how ongoing and future minimally invasive techniques are being used to monitor airmen, and give them advice for self-treatment to maximize their performance. The Pacific Diabetes Technologies speaker, Ward, showed how to use minimally invasive, subcutaneous (=under the skin) oxygen sensors to detect hemorrhage (= blood loss) and control it.En Route Care (ERC) and Point of Care (POC) DiagnosticsTreating injuries right away and correctly shortens not only a patient’s suffering, but also improves his or her chances for a full recovery. AFRL’s Matthew Dalton moderated this August 12th session. Derek M. Sorensen from AFRL, Zheng Yan from the University of Missouri-Columbia, Melinda Eaton from the Virtual Health Program Management Office at the U.S. Department of Defense (DoD), and Azar Alizadeh from General Electric (GE) Research outlined their contributions to achieving instant and professional care.AFRL’s Sorensen described the many challenges a Critical Care Air Transport Team (CCATT) deals with when performing their work inside a noisy, dark, hot, or cold, shaking airplane, discussed their equipment and personnel constraints, and explained how difficult it is, even for experienced doctors, to perform emergency surgeries under these conditions.Professor Yan takes low cost very seriously and demonstrated how he and his students have developed on-skin wearable sensors that can be manufactured by using only pencil and paper.Eaton outlined the DoD’s strategy for assuring its medical force is ready to support soldiers. Then she discussed a broad range of the DoD’s traditional health management responsibilities and added that Covid-19 is now an important factor.Alizadeh addressed how GE microelectronic solutions improve the efficiency of care, reduce medical errors and length of hospital stays as well as improve workflows of caregivers. In addition to GE’s well-known, large/stationary medical equipment and communications infrastructure (Figure 2), Alizadeh showed that GE is also providing skin patches and other wearable sensors to capture data.Figure 2: The Future of Monitoring: In 2017, Mercy Hospital served 800,000 patients with telemedicine including those with chronic diseases. Patient:doctor ratio: US average 300:1. Mercy = 1100:1. (Courtesy: GE) Human Wearables Enabling Rapid Decision Making in the Integrated Care ContinuumAs Figure 2 above shows, microelectronic equipment can improve patient care and efficiency of medical personnel, but only if sufficient data can be captured timely and accurately – increasing the importance of wearables. AFRL’s Jeremy Ward moderated this August 17th session. Christopher Scully from the U.S. Food and Drug Administration (FDA), Ashleigh Coker from the AFRL’s Sensors Directorate, Ted Harmer from the AFRL’s Airman Systems Directorate, and AFRL’s Regina Shia presented for Oxana Pantchenko from NextFlex how they develop wearables jointly. Scully introduced the FDA’s organization and its responsibilities, described the high-value accurate data can provide, warned about the damage false alarms and equipment failures can cause, and explained the regulatory role the FDA plays in this context.AFRL’s Coker highlighted the essential role sensors play in modern warfare with several examples, described her directorate’s operations and showed their warfighter-centric design process (Figure 3).Figure 3: Warfighter-centric design process steps and the need to engage multiple heads/perspectives in this process. (Courtesy of AFRL) AFRL’s Harmer addressed the importance of good communications architecture and protocols to capture and compute data to assure efficient cooperation between land/air/sea/space-based forces.NextFlex’ Pantchenko prepared a presentation about standards-compliant wearable electroencephalography (EEG), electromyography (EMG), and electrooculography (EOG) devices, jointly developed with AFRL and several other companies. It was delivered by AFRL’s Regina Shia.Automation, Augmentation and AINatalie Wisniewski, Founder of Profusa, Inc. a and consultant in Wearables and Digital Health, moderated the fourth webinar, held on August 26. She emphasized SEMI’s role in this context, then introduced the speakers: Michael Kirby from Colorado State University, Kevin Zhao from Harmonize Health, Mary Clare McCorry from armi/biofab USA, and Andreas Caduff from ETH Zuerich.Professor Kirby outlined several mathematical principles that need to be applied to get meaningful results when analyzing data. He emphasized that genetic factors influence if an individual is susceptible, tolerant, or even resistant to certain pathogens and warned that bacteria can develop resistance to today’s antibiotics.Zhao from Harmonize talked about the importance of predictive analytics in remote care, how to filter out false alarms, and how to deliver the best available care cost-effectively. In closing, he emphasized that computers and algorithms are not replacing clinical staff.McCorry outlined how biofab USA, a program of armi, uses sensors and automation to grow replacement tissue and organs (Figure 4). She explained how they use engineering principles and life sciences to make guide cells grow into replacement tissue. The company’s plan is to expand the currently lab-based capabilities into an industrial scale tissue foundry.Figure 4: Growing ear cartilage in the lab. (Courtesy: armi/biolab USA) SummaryMcCorry summarized her presentation, and actually the entire webinar series, with these statements: The human body is a 3D, highly complex, dynamic, and multi-faceted biological construct Skin lends itself well as an interface between body and wearable sensors Connecting physiology (e.g. vital signs), behavior, and external factors is important for getting good results Verification, validation, and FDA involvement are important for making methods and devices successful Sensors, communication computing (AI/ML) are complementing, not replacing, medical personnel Today’s methods and devices will be outperformed by tomorrow’s solutions – stay up to date Personal CommentsSummarizing eight hours of presentations in a few pages requires a very high and lossy compression factor – please understand. I suggest you call on your SEMI contact to get access to these previous and following webinar recordings. Excellent contacts across the electronics supply chain enable SEMI to win experts in many areas to convey valuable information in these webinars.I am impressed that the USA military, specifically the AFRL, invests so much effort in medical support for airmen/women. They demonstrate that only healthy and fit personnel can take full advantage of the sophisticated weapon systems at their disposal if/when they are called upon to deploy them.This Smart MedTech webinar series confirms what many medical experts told me during exams and/or before and after surgeries: The human body is a masterpiece of bioengineering. These webinars also reminded me of what I learned at a brain-health class at Stanford University: Our brains only need about 20 Watts to perform computing and memory tasks that fairly quickly approximate the results of today’s computers – a benchmark for computer architects and AI/ML experts.Republished with permission from 3D InCites.