IDSA Advocates for Continued Patient Access to in vitro Diagnostics

IDSA has continued to be highly engaged in the ongoing policy discussions regarding regulation for laboratory developed tests (LDTs). As currently written, the draft Diagnostic Accuracy and Innovation Act(DAIA) and U.S. Food and Drug Administration (FDA) technical assistance (TA) document propose that many LDTs be submitted to the same FDA premarket approval process as commercial tests, an unaffordable and inappropriately burdensome process for academic medical centers and hospital laboratories. The proposed regulations would be particularly harmful to transplant medicine, where LDTs have become the standard of care.

Please use this action alert to help us educate members of Congress about the critical roles ID LDTs play in patient care and public health.

IDSA submitted comments in response to the August FDA TA and drafted a joint letter with the American Society for Transplantation (AST) outlining the dangers of prohibitive regulations for LDTs used in transplant medicine.

Diagnostics Committee Chair Kim Hanson, MD, MHS, and IDSA staff met with staff from the House and Senate bill authors earlier this month to discuss specific concerns and recommendations for the next iteration of DAIA. House staff indicated that they want to introduce a revised bill as soon as possible and may also schedule a hearing this fall. At the staffers’ request IDSA is providing clear recommendations for how regulatory exemptions for LDTs should be crafted. The staff reiterated that they want to respond to patient safety concerns (which primarily orginate from other disease areas) without inappropriately hampering the work of ID clinicians and laboratorians.

If you would like to learn more about IDSA’s work on this issue or share feedback on how proposed LDT legislation may affect your practice/laboratory/institution, please email jlevy@idsociety.org.