Genetic Testing
In today’s rapidly evolving diagnostic testing landscape, the challenges and opportunities are more dynamic than ever. One often overlooked challenge to innovation in this field is that exam developers and regulatory agencies don't understand one another.
In this article, I’ll shed some light on the complex interplay between innovation, regulation, and market needs and how better communication can speed up innovation while maintaining safety and efficacy.
The Promise and Peril of Diagnostic Innovation
Diagnostic testing is undergoing a remarkable transformation with vast potential for further progress, from promising early detection of diseases to revolutionizing personalized medicine. In the case of cancer, for example, these novel exams can go beyond merely detecting the malignancy to identifying the driver mutation to that cancer. However, the journey is fraught with hurdles. While the field is advancing, the diagnostic tools available today are not as all-encompassing as one might hope.
The COVID Testing Debacle: A Cautionary Tale
As we forge ahead, we must reflect upon recent events and their implications for the future. The COVID-19 pandemic, for example, drove a sea change in the industry and market for diagnostic tests. Global populations grew comfortable with the concept of self-testing, and the infrastructure to support new methods of detecting illness was rapidly expanded, with laboratories and facilities being built to accommodate the rapidly increasing demand for test processing.
However, the COVID-19 pandemic also highlighted significant issues—the rush to deploy tests exposed vulnerabilities in regulating and validating these tools. Although several companies provided consumer diagnostic kits, their credibility was sometimes questionable, and their value was poorly defined. The self-exams provided results, but the credibility of those results was uncertain, as users didn’t know whether their at-home illness detection products were certified properly.
We can draw a parallel between the COVID testing landscape and the current state of new non-invasive cancer diagnostic tools. This “Wild West” scenario, where tests were being offered without adequate validation, led to a myriad of problems. The lack of proper certification and oversight resulted in unreliable results and heightened public distrust. As we move forward with newer and more sophisticated tests, especially for diseases like cancer, the need for more rigorous standards and proper validation is even more critical to avoid repeating past mistakes.
Regulatory Challenges and Opportunities
Regulation is paramount in shaping the future of diagnostic testing. There is an ongoing debate about FDA regulations and their impact on the industry. Diagnostic companies believe that aggressive FDA regulations could stifle innovation, limiting the playing field to only the biggest companies with the resources to conduct time-consuming studies with large groups of subjects and excessively high validation standards. On the other hand, the FDA holds that a lack of regulation and uncertain certification standards could lead to unreliable tests that potentially put patients at risk.
The FDA’s increased scrutiny and regulation are necessary to prevent the proliferation of unreliable products. However, excessive regulation could penalize small, innovative startups and limit the availability of groundbreaking advancements.
The key is to strike a balance between ensuring rigorous standards and fostering innovation. We need the FDA to regulate the quality of new tools and techniques while ensuring that regulation does not prevent groundbreaking innovations from reaching the market.
The Future of Diagnostic Testing
Looking ahead, the future of diagnostic testing hinges on several factors. Tests must be appropriately validated to ensure they deliver on their promises. It’s one thing to have a product that’s interesting, but another to rely on the results those tools generate for healthcare decisions.
Excessive validation regulations would make developing advanced tests unaffordable for startups and smaller companies, yet competition from such companies will drive down the cost of tests. If the technology to facilitate advanced diagnostics is available but unaffordable, that’s a problem. We need to ensure that the costs are manageable and that these new options are accessible to those who need them.
Different Languages Present a Technical Barrier Stifling Innovation
Surprisingly, documentation and language are among the biggest challenges for smaller companies created by the FDA’s proposed regulations. The FDA proposes a rigorous application process that standardizes language and procedures to certify tests.
The challenge for diagnostic testing startups is that the required responses to the FDA’s applications use language substantially different from how scientists typically write about their products and discoveries. The complexity of the application process requires the retention of highly skilled subject matter experts who might need to be retained for years at a cost of hundreds of thousands of dollars annually.
One potential solution to this barrier is already in development. Ad Astra, Inc., a global leader in real-time translation services, is preparing to launch a platform that ingests the documents smaller labs have already developed. Then, through AI and human subject matter experts, they’ll translate the lab’s information into the FDA’s required language and formats and prepare the applications for submission. While there are other hurdles for startups, the Ad Astra solution significantly reduces the expense of adhering to these new standards, saving smaller innovators time and helping them get their products certified before even more stringent regulations are implemented.
Conclusion
The diagnostic testing industry stands at a crossroads, shaped by past experiences and future aspirations. As we navigate this complex landscape, it’s crucial to learn from the past, address current challenges, and seize opportunities for innovation.
Novel diagnostic product developers, the FDA, and other regulators must strike a balance now that permits continued innovation while ensuring that all these ground-breaking tools are sufficiently well-validated to deliver on their promises. Using translation services that ensure labs and the FDA communicate effectively will help achieve this balance.
About the Author
Yuriy Shevchenko, PhD, is a biotechnology leader with over two decades of experience in research and development. He’s the program director of clinical and translational research projects in oncology, genetics, infectious diseases, and women's health.
