Home-use in-vitro diagnostics (IVD) allow people to test for some diseases or conditions without requiring a doctor’s office visit. These tests are cost-effective, fast, and confidential.

Some home IVD tests, like cholesterol tests, can help detect possible health issues when there are no symptoms presenting. That way, early treatment can begin before the issue becomes serious and the chance of developing later complications (heart disease, stroke) can be reduced.

Other home IVD tests spot specific conditions in order to take immediate action, like pregnancy testing or flu/COVID testing. Yet another class of tests monitors chronic health issues to allow frequent changes in treatment, for example, glucose testing to monitor blood sugar levels in patients with diabetes.

Home-use IVD medical devices are meant for use by the general public, so they are designed to have relatively simple and easy operating procedures compared to professional or laboratory IVDs offering similar functions. With reference to the test results, users can monitor their health conditions.

At-home IVD tests designed for use at home are generally available in the form of strips, cassettes, dip cards, and digital monitoring devices. Growth of the home IVD testing market comes from a paradigm shift among consumers who want more control over their own healthcare. Thanks to increased use of the internet for medical information, consumers have become medical consumers, not just patients.

This has created a change in the doctor/patient relationship as people become more knowledgeable about their own health and want more control over their personal information and treatment decisions. Consumers are also more cost-conscious, and the growth of high-deductible insurance plans requires that people ask more questions, do their own research, and collaborate with their doctors about medical decisions, tests, and treatments.

The U.S. Food and Drug Administration (FDA) has been clearing over-the-counter (OTC) IVD tests nearly since the start of its premarket regulation of devices. The first OTC IVD cleared by the FDA was a qualitative dipstick urine glucose test in 1977, followed shortly by the first OTC pregnancy test clearance in 1978. Since then, the FDA has cleared about 1,200 OTC IVDs.

The FDA has repeatedly expressed its support of OTC and home testing, particularly in the context of the COVID-19 pandemic, where the value of home diagnostic testing has been undeniable. The FDA currently lists 40 authorized COVID-19 home tests.

The types of tests that can be done at home continues to expand. In December 2023, Everly Health launched a comprehensive, at-home collection kidney health test for health plans and employers to expand access to chronic kidney disease (CKD) prevention, diagnosis, and treatment.

The Everly Health At-Home Collection Kidney Health Test is the combination of an estimated glomerular filtration rate (eGFR) through blood collection, estimating kidney function, and a urinary albumin-to-creatinine ratio (UACR) to assess kidney function through urine collection. Everly Health uses state-of-the-art technology and processes tests at CLIA-certified and CAP-accredited labs to ensure tests meet or exceed the accuracy of traditional laboratory tests. The collection methods used for the Everly Health Kidney Health Test have a correlation of over 98.6% when compared to standard collection methods, according to the company.

The patient experience is simple: program participants receive their at-home test kit, collect a sample, and mail it back in a pre-paid envelope. Participants receive shipping and processing updates, in addition to the test results and notification of any potential abnormalities, electronically. Participants also receive actionable next steps from a healthcare provider if appropriate.

“Kidney disease affects 37 million adults in the United States but 90% are unaware they even have it, which makes it a silent killer,” Everly Health solutions chief commercial officer Liz Kwo, MD, told the press. “We have an opportunity to significantly change the course of chronic kidney disease in the United States by working to ensure early detection is available to people through the testing they need to protect their kidney health.”

Of course, home testing and self-collection is merely a segment of the large IVD testing market. In order to gain more information about the overall IVD market’s trends and challenges, MPO spoke to a number of experts in the field over the past few weeks:

• Jeff Bradbury, senior director of business development at TEAM Technologies, a Morristown, Tenn-based end-to-end manufacturing solutions provider for medical and dental products.
• Ned Burnett, strategy and innovation manager at Saint-Gobain Medical, a Solon, Ohio-based designer, developer, and manufacturer of custom medical components and engineered systems for medical devices.
• Julie Cameron, CEO of Innovize, part of Excel Scientific. Innovize is based in St. Paul, Minn., and offers custom development and manufacturing solutions—including converting and contract manufacturing—for product designers, developers, engineers, and supply chain managers.
• Krista Ewing, Ph.D., diagnostics product manager at Porex, a Fairburn, Ga.-based developer and manufacturer of porous plastics, sintered PTFE, porous polymer fiber, porous polypropylene, and porous membranes.
• John Faulkner, VP of sales and marketing at BMP Medical, a Sterling, Mass.-based provider of contract manufacturing services for the medical device industry; producing plastic consumables used in devices and diagnostic kits.
• Steve Lents, Chief Revenue Officer of TEAM Technologies.
• Jonathan Maa, COO of Maxim Biomedical, a Rockville, Md.-based diagnostic healthcare company enhancing global health through development and manufacture of diagnostic solutions.
• Brian Matachun, VP of sales and marketing at Plastic Design Company, a Scottsdale, Ariz.-based specialty manufacturing company focused on precision injection molding and value-added assembly for medical devices and life sciences.
• Richard Wiesli, sales and marketing manager, TreffLab, at Nolato. Based in Torekov, Sweden, Nolato develops and manufactures both customer-specific and standard products in polymer materials for a wide range of sectors.

Sam Brusco: What are the main trends and challenges you see in the IVD market at present?

Jeff Bradbury & Steve Lents: In general, the IVD industry is seeking ways to capitalize on post-COVID-19 lessons learned and leverage the momentum gained during the pandemic by exploring new opportunities and applications beyond infectious disease diagnostics. The industry had to deliver viable solutions at an accelerated pace. This expectation seems to have continued post-COVID with customers expecting a shorter development cycle as well as the ability to quickly scale production. While lateral flow tests gained significant attention for COVID-19 diagnostics, there are numerous other applications where this technology can be utilized. These include veterinary diagnostics, environmental testing (e.g., water quality testing), food safety testing, drug testing and monitoring, cancer biomarker detection, and monitoring chronic diseases (e.g., diabetes, heart disease).

There are also technology advancements and it’s important to invest in research and development to enhance the capabilities of lateral flow assays. This includes improving sensitivity and specificity, developing multiplex assays for simultaneous detection of multiple analytes, integrating digital and smartphone-enabled platforms for result interpretation and data analysis, and incorporating nanotechnology for improved performance and sensitivity.

Point-of-care testing (POCT) expansion is another trend. Leverage the convenience and rapid results offered by lateral flow tests to expand into new point-of-care testing markets, including pharmacies and drug stores, clinics and urgent care centers, remote or resource-limited settings, and workplace testing.

Ned Burnett: One of the primary hurdles confronting the IVD market today is navigating the intersection of sustainability imperatives and regulatory concerns, particularly concerning the transition away from PTFE components. PTFE has historically been favored for its exceptional chemical compatibility, flexibility, and transparency in the IVD sector. However, transitioning away from this material class presents one of the most significant challenges currently facing the industry. Companies like ours are well-positioned to help customers find PTFE alternatives and drive innovation in the space in partnership with the OEMs.

Julie Cameron: The trends we see are adoption of personalized medicine, an increased focus on prevention, as well as more frequent therapeutic drug monitoring, conveniently and fast. IVD has supplemented laboratory tests with point of care testing, then further advanced to what I would call self-diagnostics/self-care. The trend toward self-care includes not just diagnoses or treatment of disease or pain but vitality, expanding our market. This trend supports the need for wearables, where we are experiencing interest in our manufacturing capabilities and know-how.

The main challenges are developing shelf stable solutions that maintain the purity and efficacy of key reagents which drive results from minimal sample sizes, economically. Another is incorporating shelf stable reagents, precise microfluidics, and sometimes flexible circuits in a flexible, disposable device. This takes broad and deep experience.

Krista Ewing, Ph.D.: There is a rising demand for rapid and decentralized testing solutions that enable diagnostics to be performed closer to the patient, such as in physician offices, pharmacies, and remote settings. POC devices facilitate quicker diagnosis, treatment initiation, and monitoring—particularly in critical care scenarios.

With the increasing emphasis on patient-centered care and convenience, there is a growing interest in home-based sample collection or diagnostic testing kits. These kits enable individuals to collect samples independently, leading to early detection of diseases and improved management of chronic conditions.

Developing assays that are suitable for POC or home testing must be robust enough to produce accurate results outside of traditional laboratory settings. Choosing the right materials is crucial to ensure the accuracy and reliability of POC and home testing devices. Materials must be compatible with the intended use, sample types, and testing methods while maintaining stability and performance over time.

John Faulkner: We anticipate a rise in the development of automated laboratory platforms, capable of processing numerous samples concurrently. Such systems significantly increase testing capacity and efficiency, crucial for handling surges in cases. Moreover, these automation platforms will help alleviate the scarcity of skilled labor. Additionally, we expect ongoing technological advancements, with some tailored towards more remote testing environments. However, regulatory obstacles remain a challenge for IVD manufacturers. Nevertheless, many manufacturers have implemented resilience strategies into their facilities, mitigating the risk of supply chain disruptions.

Jonathan Maa: Creating single diagnostic tools that can detect multiple infectious diseases at a given time is crucial for global readiness. Some of our biggest clients have engaged us in developing new advanced diagnostic tools to ensure better preparedness for specific breakouts. Additionally, there is a growing demand for rapid and convenient diagnostic tests that can be performed at doctor’s offices, clinics, and at home. These devices provide quicker results, enabling faster treatment decisions and ultimately improving patient outcomes.

Brian Matachun: The IVD market is currently experiencing significant transformation driven by technological advancements and increasing demand for personalized medicine. Key trends include the rapid progression of next-generation sequencing (NGS), microphysiological systems (MPS), and digital PCR (dPCR) technologies, which require highly precise components. Additionally, the integration of artificial intelligence and machine learning for diagnostics presents both an opportunity and a challenge, requiring OEMs to continuously adapt to new technologies.

However, these advancements also come with challenges such as the need for stringent quality control, regulatory compliance, and the ability to scale production efficiently without compromising quality. With a degree of excess capacity now present in the market, OEMs have an opportunity to select manufacturing partners that have demonstrated experience and expertise in dealing with high-throughput manufacturing, ultimately ensuring that innovations continue to reach the market without delay.

Richard Wiesli: Production quality, precision and reasonable automation are production standards today. Ever-increasing legal regulations for validation and documentation require modern networked systems between production, quality assurance, and metrology instruments. Computer-aided qualification software and fully automated inline measurement by cameras and inline exchange of faulty products are real challenges by the attempt to keep the overall product cost in the target range. Miniaturization, less use of costly process ingredients, new polymer regulations such as PFAS, and new multi-functional consumables supporting specific assay procedure steps and traceability down to the single consumable are present trends which we are already addressing.

Also, CO₂ footprints as an additional decision parameter for cavity numbers and final IVD consumables polymer consumption, is a new demand we cope well with. Four technical design centers at all three continents (USA, EU, Asia) are ready to support our international OEM customers with this new and exciting software-based support.

Brusco: What effect did the COVID-19 pandemic have on IVD operations, and what lessons were learned for future global health events?

Bradbury & Lents: Undoubtedly, the biggest overarching issue is the remaining excess capacity created during the pandemic and how do companies reappropriate that manufacturing volume in this post-COVID era. We experienced unforeseen volume increases and supply chain pressures as we supported customers’ needs. Fortunately, we were poised to support die cutting, lamination, injection molding, assembly, and packaging needs by merely adding people and expanding shifts without adding capital expenses.

The pandemic highlighted the critical need for rapid and accurate diagnostic testing to control the spread of infectious diseases. The demand for rapid testing solutions has surged, leading to the development and adoption of innovative technologies such as lateral flow assays and point-of-care testing (POCT) devices. Companies supporting the diagnostic space also learned the importance of flexibility and scalability in response to rapidly evolving public health crises. Companies have recognized the need to adapt manufacturing processes, supply chains, and distribution networks to meet surges in demand during emergencies while maintaining quality and reliability.

The collaborative efforts between diagnostic companies, healthcare providers, government agencies, and research institutions have been instrumental in responding to the pandemic. The crisis emphasized the importance of collaboration and information-sharing to develop, validate, and distribute diagnostic tests quickly and efficiently. Regulatory agencies demonstrated agility and flexibility in responding to the urgent need for COVID-19 diagnostic tests. Emergency use authorizations (EUAs) were granted to expedite the approval process for new tests, allowing companies to bring products to market more rapidly while ensuring safety and efficacy.

The pandemic exposed vulnerabilities in the global supply chain for diagnostic reagents, components, and equipment. Overall, U.S. and nearshore manufacturing offered distinct advantages during the COVID-19 pandemic, enabling companies to mitigate supply chain risks, enhance resilience, and maintain continuity of operations amidst unprecedented challenges. As a result, many organizations have reevaluated their sourcing strategies and are increasingly prioritizing domestic and nearshore manufacturing to build more resilient and agile supply chains for the future.

Cameron: COVID drove the need for in-vitro diagnostics that were not dependent on trained medical staff to administer, accelerating adoption of home use kits. This has continued to evolve into diagnostic platforms which have the flexibility to address a range of needs and self-care platforms (home kits, wearables, etc.).

Dr. Ewing: As the pandemic led to an unprecedented surge in demand for diagnostic tests and exposed vulnerabilities in the IVD supply chain, material suppliers experienced heightened demand for critical components, leading to supply shortages and challenges in meeting global demand.

However, the urgent need for testing spurred rapid innovation in diagnostic technologies and testing platforms. Material suppliers played a crucial role in supporting innovation by providing novel solutions for the development of new diagnostic tests, and continue to partner with IVD developers on new solutions as well as risk management for future global health events.

Faulkner: The COVID-19 pandemic impacted IVD operations across various fronts. It underscored the necessity for comprehensive preparedness strategies and the establishment of resilient supply chains. Additionally, it prompted leading OEMs to reassess their choices regarding outsourcing IVD manufacturing, emphasizing the importance of transparency with CMO partners and fostering closer, more collaborative working relationships.

Maa: Lessons learned from the COVID-19 pandemic for future global health events include strategies around building a preparedness and resilience plan that includes stockpiling, and onshoring manufacturing as it applies to essential medical supplies and infectious disease detection devices. We have also encountered enhanced collaboration among governmental agencies at our facility in propelling diagnostic technology forward at an accelerated pace.

Matachun: The COVID-19 pandemic underscored the critical role of IVD in global health, highlighting both strengths and areas for improvement in diagnostic operations. One significant impact was the unprecedented surge in demand for testing kits, which strained supply chains and emphasized the need for robust and flexible manufacturing capabilities. The most successful companies were those that demonstrated an ability to rapidly upscale production capacities to meet urgent and unforeseen demands.

From this experience, several key lessons were learned. The importance of having agile and resilient manufacturing processes that can adapt to sudden changes in demand was a primary takeaway. Additionally, the pandemic highlighted the necessity of close collaboration between manufacturers and OEMs to facilitate quick responses to health crises. Leveraging these lessons, we are better prepared for future global health events, with strengthened processes and the ability to support the development of innovative diagnostics as science advances.

Wiesli: To cope with the new challenges of pandemic waves and its dynamics, capabilities such as increasing production output by factors (not percent) within months, detecting and coping with polymer supply shortages in a timely manner, and understanding the instrument assay itself to understand the key function and sensitivity of a consumable are new dimensions in the IVD market and its consumables supply. Speaking of the pandemic, you must keep an eye on the supply chains.

Shortage of containers, double to triple delivery times, and the failure of entire container shipping lines endanger central production. We are observing a clear trend at our worldwide active customers towards minimizing risk by establishing local supply resources. We have a well-developed network of local production facilities in North America, Europe, and Asia. These short routes to the customer guarantee good communication, usually in the local language, short ways to the customer site, good availability of the products, and cost-effective delivery routes.