TriCore Urges FDA to Reconsider Proposed Ruling to Regulate Lab Developed Tests


November 27, 2023


Commissioner Robert Califf

U.S. Food and Drug Administration 10903 New Hampshire Ave

Silver Spring, MD 20993


Response to Docket No. FDA-2023-N-2177: Proposed Rule on Medical Devices; Laboratory Developed Tests


Dear Commissioner Califf:


We write to express our deep concerns regarding the FDA proposed rule for the regulation of laboratory developed tests (LDTs) as outlined in Docket No. FDA-2023-N-2177. As concerned stakeholders, we believe that the implementation of this rule, as currently proposed, will have significant adverse effects on patient access to testing, innovation, and the practice of laboratory medicine.

The potential for increased regulatory requirements will most certainly lead to delays in the availability of new tests and limit patient access to cutting-edge diagnostic tools. This could be especially problematic in situations where timely and accurate testing is essential for patient care, such as in the diagnosis and management of rare diseases or during public health emergencies. Additionally, the estimated costs associated with the proposed rule are disproportionately high and will severely restrict patient access to LDTs. FDA MDUFA fees, clinical study costs, and the burden of LDT resubmissions pose significant financial challenges to laboratories. These financial challenges will lead laboratories to evaluate LDT offerings solely from an economic perspective, potentially resulting in the consolidation of LDTs to only a few laboratories in the country. This consolidation will cause longer turnaround times, reduced resiliency, and a lack of redundancy, especially in times of crisis such as witnessed during the COVID-19 pandemic.

We believe that the proposed rule will stifle innovation within the field of laboratory medicine by imposing regulatory burdens that will be particularly challenging for all clinical laboratories, including those in large academic medical centers and smaller, community-focused laboratories. The flexibility historically afforded to LDTs has been crucial in the development of novel and specialized tests that address specific patient populations or emerging health threats. As you are aware, LDTs play a crucial role in addressing clinical needs where commercial alternatives are inadequate or non-existent. This is particularly evident in pediatric care, where specialized tests for the diagnosis and monitoring of biochemical genetic disorders are performed with LDTs.

The proposed rule fails to recognize that the vast majority of LDTs are routine tests without commercial counterparts. As examples, tests for some hormones, most vitamins, immunosuppressive drugs, trace elements, confirmation testing for positive urine drug screening tests, and nucleic acid tests for novel mutations, are all essential for addressing clinical needs that are not met by commercially available alternatives. LDTs also address critical testing when the sample type is different than what is listed in the insert on a commercially available test. LDTs exist because there is a clinical need for them to exist and we are concerned that overly burdensome regulations will negatively impact their availability.

There is a common misconception that LDTs are not regulated when, in fact, they are subject to regulation under the Clinical Laboratory Improvement Amendments (CLIA). LDTs are thoroughly validated to all elements required by CLIA in addition to elements deemed necessary by the laboratory director (i.e. clinical utility).

Furthermore, like all clinical laboratory tests, LDTs are subject to frequent proficiency testing, with any failures being thoroughly investigated, mirroring the scrutiny applied to FDA-approved/cleared tests. Notably, the evaluation of LDTs extends beyond the initial validations, involving continual monitoring of both quality and performance. In contrast, once an FDA-approved/cleared test is introduced to the market, there is comparatively little ongoing monitoring of its performance by the FDA, highlighting the rigorous and constant oversight conducted by individual laboratories.

There are virtually no compelling data that suggests the use of LDTs has harmed patients. Often cited examples are often misrepresented and FDA has yet to amass comprehensive information regarding the full spectrum of LDTs in use and their impact on patient care. Rather than reliance on selected examples, accumulating a comprehensive evidence base that reflects the diverse applications of LDTs is required before instituting broad regulatory measures. We strongly recommend that the FDA postpone the implementation of its proposed LDT requirements until a more thorough compilation of data on LDTs is conducted and made publicly available.

In conclusion, while we recognize the importance of ensuring the safety and effectiveness of clinical laboratory tests, we believe that the proposed rule will have many unintended consequences that outweigh its potential benefits. We urge the FDA to carefully reconsider the current approach, taking into account the concerns raised by stakeholders and exploring alternative regulatory strategies that strike a more appropriate balance between innovation, patient access, and safety.

Thank you for considering our comments. We appreciate the opportunity to contribute to the rulemaking process.




Robin Divine, EMBA

Chief Executive Officer, TriCore


Eric Carbonneau, MS, MLS(ASCP)

Chief Operating Officer, TriCore


David G. Grenache, PhD, MLS(ASCP)

Chief Scientific Officer, TriCore

TriCore Clinical Professor of Pathology, University of New Mexico


Ella Watt

Chief Financial Officer, TriCore