The Association for Diagnostics & Laboratory Medicine (ADLM, formerly AACC) remains concerned that the Food and Drug Administration’s (FDA’s) final rule to regulate laboratory developed tests (LDTs) will hinder the ability of healthcare institutions to deliver timely and high-quality patient care.
Under the rule, certain LDTs will be exempt from the full FDA review process, but will still be subject to other FDA regulatory requirements. A previous survey of clinical laboratories conducted by ADLM looked at whether these exemptions would preserve patient access to these essential tests. The results overwhelmingly indicated that labs are not equipped to meet the FDA’s regulatory requirements in addition to the Centers for Medicare & Medicaid Services (CMS) regulations that labs are already subject to, and that many labs will be forced to discontinue their exempt tests.
As a follow up to this, the latest ADLM survey focused on non-exempt tests. The survey asked participants, if their tests do not qualify for an exception under the new FDA rule, will they seek FDA authorization for their LDTs or will they discontinue them? Among the 121 respondents, 48% said they would not seek approval for their LDTs, and would instead discontinue the tests. This would mean that among the estimated 12,000 laboratories qualified to do LDTs in the United States (out of more than 300,000 U.S. clinical labs), nearly 6,000 will stop offering these critical tests.
Other findings from the survey include:
- More than 60% of responding laboratories (n=159) said that there is no alternative laboratory within their state to offer the LDTs they perform should they decide to discontinue the LDTs at their institution. This means that the new FDA rule will create a hardship for many individuals, particularly among marginalized communities and those living in rural areas, who do not have the means to travel to another region of the country to obtain the tests needed to diagnose and treat their conditions.
- Nearly 90% of participants believe CMS should provide additional oversight of LDTs, should it be required.
In light of these survey results, ADLM urges lawmakers to rescind the FDA rule and to discuss separate remedies to streamline the FDA review process and review and update CMS standards pertaining to LDTs.
Figure 1: Laboratories’ decision to seek FDA approval for their LDTs should they fail to qualify for an exception under the final FDA rule.
ADLM has sent a letter about the survey results to the U.S. Senate Committee on Health, Education, Labor, and Pensions (HELP) and the House Committee on Energy and Commerce.
View the letter and full survey results here.
PAST SURVEY RESULTS
Prior to the publication of FDA’s final rule, ADLM conducted a survey that found that FDA regulation of laboratory developed tests would hinder pediatric care.
Following the publication of the final rule, ADLM conducted a second survey showing that, in spite of the exemptions that the rule carves out, clinical labs are still not equipped to meet the rule’s new requirements.
ADLM will continue to update this page with the latest survey data.