Point of Care (POC) and at-home rapid diagnostic testing has been an increasingly hot topic in healthcare since COVID-19 proved the necessity and possibility of alternative diagnostic technologies and methods. Today, it is a booming market segment featuring some of the most impressive growth and innovation the healthcare field has to offer. Here, we will explore three critical considerations for device developers and manufacturers looking to create their next-generation diagnostic devices.
The Decentralization of Diagnostic Testing and CLIA
As diagnostic capabilities become more widely available in spaces outside the typical laboratories and point-of-care clinics, it is critical to address the unique regulatory challenges of at-home testing to ensure quality and efficacy across testing locations. Today, the FDA's Emergency Use Authorization (EUA) for POC and at-home diagnostic devices, issued during the height of COVID-19, provides coverage for a number of such on the market. Upon its inevitable termination, however, the companies behind these devices will not only need to seek traditional 510(k) clearances but also address, where applicable, a combined CLIA waiver status from the FDA.
CLIA, or Clinical Laboratory Improvement Amendments, refer to the federal law establishing quality standards for diagnostic testing to ensure patient results' accuracy, reliability, and timeliness no matter where tests are performed. Given the already massive and still rising number of tests now performed by non-laboratory personnel, the industry stands at the precipice of a bottleneck of current EUA devices that will need to be re-addressed for approval from multiple perspectives, particularly in the case of POC diagnostic systems.
In the case of At Home testing, any test that has been cleared, approved, or explicitly authorized for home use by the FDA will not be regulated under CLIA so long as that test is self-administered in accordance with FDA authorization and authorized labeling. This includes testing as performed by an individual on behalf of a child or adult unable to perform the test themself, such as in the case of a parent, guardian, or caregiver. This manner of testing, performed to the extent authorized in the manufacturer's Instructions for Use (IFU), is considered self-testing for CLIA purposes and thus does not require certification.
Generally, manufacturers include separate IFUs for OTC home use and healthcare provider-facilitated testing, the latter of which must be performed in a CLIA-certified facility. However, in the case that a test is performed by an individual other than the test's subject, a CLIA certificate is necessary. This is also true in the possibility that a test's results are interpreted or reported by an individual other than the test's subject. Thus, it is critical to refer to the appropriate instructions based on the testing location to ensure compliance.
Data Privacy Challenges in POC and At-Home Testing
Although the prospect of revolutionizing and democratizing diagnostics is sure to excite many, few are likely to respond with enthusiasm to the idea of widespread data collection and sharing, particularly in the medical field. Yet, data sharing remains critical to ushering in the next generation of diagnostic practices, accelerating scientific discoveries, providing clinical utility, and enabling technological advancements. As such, device companies must commit to instituting ethical data-sharing practices within their business plans.
Occurring throughout development, from research to development to commercialization, there are several key components to consider concerning data privacy in next-gen diagnostics. These include collecting informed consent, guaranteeing data security, protecting patient anonymity, data usage transparency, and properly deploying beta testing for data sharing. As health records contain personal, sensitive information that most prefer to keep private from employers, insurers, friends, and even family, their privacy is paramount and even protected by specific federal regulations. Yet, advancements in technology outpace policies and mandated practices, meaning that individuals, companies, stakeholders, and policymakers must all play an active role in ensuring the responsible use of personal data.
For example, smartphone applications have become increasingly popular as healthcare tools, yet they can easily suffer from insecure data storage and present a significant risk of breaching patient privacy. These risks can complicate informed consent and may come in the form of data leaked through automatic backup systems, accidental sharing to social media, or any other insecurities encountered due to connectivity. It is critical that device developers actively address issues such as these during any device and systems development process, initiating ethical discussions with patients, providers, and researchers that will shape the integration of molecular diagnostics with electronic medical records. Although decentralization is no doubt a noble goal, it remains that ethical challenges should always be balanced with equal weight to technological progress.
Multiplex Testing and Advancing Molecular Diagnostics
Sparked by the invention of rapid at-home tests for COVID-19, there exists today a growing demand among consumers for at-home test kits to be kept as part of a family's first aid kit to enable faster, more independent medical decision-making without a trip to the doctor. Rapid multiplex testing is an attempt to meet this demand— a practice in which multiple biomarkers are detected or identified within a single at-home or POC diagnostic test. For device manufacturers, opportunities abound for home diagnostic kits detecting common infectious diseases such as COVID-19, hepatitis, flu, and their various respective strains, all within a single multiplexing test. Beyond infectious diseases, there also exists significant interest in wellness monitoring kits allowing patients to record blood sugar, cholesterol, iron, and vitamin levels via a single multiplexing test.
A fast-growing segment of the rapid testing market, multiplexing has many benefits, perhaps the most notable of which is its significant impact on medical decision-making. Optimizing process results while allowing for more convenient, comfortable sample collection, multiplexing reveals prognoses. It eliminates them as well, making them powerful tools in diagnosis processes requiring ruling out other conditions.
For example, most viral respiratory illnesses are difficult to diagnose based on symptoms alone. Multiplex testing allows physicians to quickly and accurately identify underlying infections and thus make critical decisions towards patient management, e.g., medication or isolation requirements, far more effectively than with standard tests. Meanwhile, they can also identify co-infections that may have worse prognoses and require different treatment techniques than a single pathogen infection might. They can be invaluable to informing public health measures, as they allow researchers to more quickly and accurately identify outbreaks to prevent viral spread, particularly in high-risk settings such as hospitals and long-term care facilities.
While multiplex testing can be a boon to any patient, high-risk patients such as children, the elderly, and the immunocompromised are mainly given to co-infection and severe illness and often require specialized treatment.
Beyond respiratory illnesses, demand is rising for molecular diagnostic options for some infectious diseases, including diarrheal diseases, sexually transmitted infections, and urinary tract infections. These tests are often faster and more sensitive than standard culture tests.
As one of the most significant and most rapidly expanding segments of the healthcare industry today, Point of Care and At Home diagnostic testing devices are some of the most cutting-edge the field has to offer. While antigen testing using the lateral flow assay method is common, there are also Nucleic Acid Amplification or NAAT technologies consisting of next-generation molecular diagnostic applications such as RT-PCR, LAMP, and CRISPR.
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