Today, diagnostic tests fall into two categories; those regulated by the U.S Food and Drug Administration (FDA) and Laboratory developed tests (LDTs). LDTs are often smaller scale tests, developed and used at single laboratories, regulated based on the provisions for laboratory testing in the CLIA (Clinical Laboratories Improvement Amendments) law of 1988 that allows laboratories to develop their own tests without premarket approval, as long as they maintain compliance with appropriate processes and procedures. CLIA compliance is established by external inspections, such as by the College of American Pathologists (CAP), that review the documentation of test development procedures. This is a long-standing approach that has streamlined physicians’ access to the diagnostic tests they may need to inform their decisions.
Yet just like many industries, healthcare has evolved as technology has developed, meaning patient safety protocols must evolve as well. Late last year, the FDA issued proposed rulemaking signaling their intent to update the regulations around LDTs and bring them under the FDA’s oversight, but to date, no formal policy changes have been enacted. Now, members of the FDA and Centers for Medicare & Medicaid Services (CMS) are reinvigorating the push for change.
What the New Guidance Recommends
Traditionally, the FDA opted to focus on regulating diagnostic tests from large manufacturers, and LDTs were overseen by CMS through CLIA, mainly due to commercial tests’ higher complexity. However, modern LDTs have become quite complex as well, as have the patient risks associated with suboptimal or inconsistent test performance. For example, there has been evidence that some LDTs may lead to over- or under-treatment or incorrect diagnosis, especially of rare diseases.
As a result, a joint statement from the FDA and CMS issued last month proposes that LDTs should fall under the same enforcement as other diagnostic tests, meaning all tests would be overseen by the FDA. While CLIA regulation is valid and LDTs can and very often do work safely, the groups see an opportunity to further improve and maintain the safety of LDTs through collaboration. Specifically, the FDA offers expertise that is quite different from CMS, and is better equipped to assure that these tests work properly. With CLIA and new FDA protocols working together to guarantee all tests adhere to the highest possible safety standards, the aim is to elevate the quality and outputs of every test being used in a clinical setting.
What the Guidance Means for Physicians and Patients
Diagnostic tests play a critical role in a patient’s healthcare journey – they inform diagnosis, treatment, and ultimately, they affect outcome. The enhanced regulations would prevent test manufacturers from releasing inadequately controlled or validated tests, such that only the highest quality tests enter the clinic. Similarly, creating safeguards that increase the chance for every test to perform as effectively and consistently as possible could help labs minimize instances of misdiagnosis and ensure patients benefit from more precise treatment.
What Paige Does to Protect Patient Safety
Paige has always been dedicated to protecting patient safety by holding our products, which support cancer detection and diagnosis, to the highest standards in the industry. We do this by leveraging large-scale datasets that include images from numerous labs around the world along with diverse patient populations, employing stringent testing and validation procedures, and importantly, working together with the FDA. In 2021, Paige received the first ever FDA approval for an AI product in pathology, Paige Prostate Detect*. Since that time, we have also earned breakthrough designation on Paige Breast Lymph Node.
These designations provide reassurance that the clinical-grade Paige products are generalizable and safe for use in the clinical setting so pathologists can feel confident in every diagnosis they make with assistance from Paige. Our plan is to continue to work with the FDA as we develop and deliver new and innovative products to the market, and that doing so will set the standard for the entire industry, elevating the quality of pathology AI tools available on a global scale.
While LDTs are valuable for many reasons, the priority should always be the best care and safety of the patient. We are excited to see that the FDA and CMS are working together to drive patient safety forward and improve cancer care with this initiative.
*In the United States, Paige Prostate Detect (DEN200080) is approved for clinical use with Philips Ultrafast Scanner.
