ASCP Needs your Help to Stop the LDT Proposed Rule

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ASCP is opposing the Food and Drug Administration’s (FDA) recently released proposed rule to dramatically increase federal regulatory requirements for laboratory developed tests (LDTs). The FDA’s proposed rule would lump LDTs into the existing regulatory scheme for medical devices, and half of them could require premarket approval. This may prevent many laboratories from offering these services to their patients.

LDTs are part of the routine provision of care to many patients with many different conditions. They are frequently developed and deployed in hospital laboratories to provide care for patients in their own facilities suffering from various infectious diseases, cancers, and other disorders. They play a crucial role in day-to-day medical care, including (but not limited to) the establishment of immunophenotypes for appropriate classification and treatment of leukemia and lymphoma, determining genetic and genomic status for purposes of determining appropriate treatment and appropriate screening per current standards of care, advanced chemical analysis methods for rapidly changing toxicology and therapeutic drug monitoring needs, tissue typing for transplant, and others.

While ASCP is open to certain regulatory enhancements for LDTs, we are concerned that requiring full-scale premarket approval by the FDA of such a wide range of important laboratory tests would negatively impact patient care.

To protect quality patient care, ASCP is urging you to use the ASCP e-Advocacy Center to send the FDA and your members of Congress a message that you oppose the rule. 

Note: If you have recently taken part in ASCP’s campaign to extend the comment period on this rule, please know that the FDA has not extended the comment period. Therefore, we are asking you send the FDA and Congress a new message opposing this rule.] 

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