The LDT rule. I am going to keep this blog brief, because there are many posts on several media already, all with many thoughts and considerations. What I blog about today, is looking at it from patient perspective.
As FDA points out in their proposed rule (PR), “an LDT to be an IVD that is intended for clinical use and that is designed, manufactured, and used within a single laboratory that is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA)… “ and “at the time of passage of the MDA, LDTs were mostly manufactured in small volumes by laboratories that served their local communities. They were typically intended for use in diagnosing rare diseases or for other uses to meet the needs of a local patient population,…” and “They also tended to employ manual techniques (and did not use automation) performed by laboratory personnel with specialized expertise; to be used and interpreted by physicians or pathologists in a single institution responsible for the patient (and who were actively involved in patient care); …”
Since we are constantly evolving above has become outdated. Local labs accept samples from all over the nation and there is more automation. FDA points out “In 2015, the Agency published a report of 20 case studies involving inaccurate, unsafe, ineffective, or poor quality LDTs that caused or may have caused patient harm (“2015 Report”) (Ref. 11). More recent evidence suggests that the situation is getting worse.” and ”Of the first 125 EUA requests for COVID–19 molecular diagnostic tests submitted from laboratories, 82 showed test design or validation problems…”
This sounds as these are all the right reasons to get a rule into place. A few things I would like to highlight. Has there been considerations by FDA that:
- LDTs are consistently re-evaluated and re-assessed by laboratories ensuring the latest greatest is brought to the patient, while ensuring quality, safe and effective devices in compliance with Clinical Laboratory Improvement Amendments (CLIA). Real World Data (RWD) is being used to optimize their LDTs. While FDA authorized devices, might have to go through an FDA review process, causing potential delay to bringing improved care to patients. Especially in this digital era, where rapid development cycles resulting in improvements are not unlikely.
- LDTs are often less expensive and also have a higher chance of having a Proprietary Laboratory Analysis (PLA) code making their use economically more attractive.
- this could impact the demand for Analyte Specific Reagents (ASRs). Vendors need to find ways to get compensated to remain profitable. This could cause a ripple effect and increases costs of IVDs, which patients might have to pay for.
It is key we all review this rule and provide comments. I know I will contribute! Together with our team, i.e., Digital Pathology Association Regulatory & Standards Taskforce we will put our efforts in to provide comments.
