AABB Asks FDA to Clarify That Proposed LDT Regulations Will Not Apply to Relationship Testing

In response to the Food and Drug Administration's proposed rule on laboratory-developed tests (LDTs), AABB has requested that the agency clarify that forensic kinship and relationship testing (DNA) tests used exclusively for legal and immigration proceedings, criminal investigations and identification of human remains be excluded from the proposed rule.

In a Dec. 1 letter to FDA Commissioner Robert M. Califf, MD, AABB noted its appreciation for FDA's efforts to ensure the safety and efficacy of LDTs but expressed concerns regarding the agency’s assertion of "longstanding enforcement discretion" over tests intended solely for forensic (law enforcement) purposes, regardless of whether these tests are offered as LDTs.

AABB’s comments emphasized the distinction between forensic and clinical testing, noting that FDA lacks authority over forensic DNA testing labs that exclusively serve legal and investigative functions. AABB also stressed that these labs do not fall under the Centers for Medicaid and Medicare Services (CMS) Clinical Laboratory Improvement Amendments (CLIA) regulations due to their non-clinical nature.

In addition, AABB noted that the National Institute of Justice, rather than FDA, governs forensic labs, including those conducting relationship testing. Furthermore, the letter underscores the AABB accreditation program’s compliance with FBI Quality Assurance Standards, ISO standards, and recognition by the U.S. Department of State and U.S. Citizenship and Immigration Services.

AABB concluded by asking FDA to clarify that the definition of “tests intended solely for forensic (law enforcement) purposes” only applies to tests within FDA’s jurisdiction. AABB believes that these proposed regulations should not apply to tests performed by forensic DNA testing laboratories that fall outside of FDA’s purview.