Analyte Specific Agents/Laboratory Developed Tests

ASM Statements

• October 6, 2010 – ASM Cosigns Letter to FDA Regarding LTD Registry Concept
  The ASM cosigned a letter to the Food and Drug Administration (FDA) to express concern about a concept under FDA consideration whereby laboratories might have to register and list the laboratory developed tests they develop.

• September 15, 2010 – ASM Cosigns Letter to FDA to Encourage Interactive Dialogue on LDTs
  The ASM cosigned a letter to the Food and Drug Administration (FDA) regarding the clinical and public laboratory community’s desire to engage with the FDA in an interactive dialogue to explore and seek solutions that will not disrupt innovation and the value laboratory developed tests bring to patient care.
  

• July 20, 2010 - ASM Presents Comments to FDA/CDRH at Public Meeting on Oversight of Laboratory Developed Tests: Clinical Lab Challenges
  On July 20, the ASM presented comments at a public meeting sponsored by the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Oversight of Laboratory Developed Tests (LDTs):  Clinical Lab Challenges.  The purpose of the meeting was to provide a forum where interested stakeholders could present comments regarding reasonable and effective regulation of LDTs.  The meeting took place in Hyattsville, MD on July 19-20, 2010. 
  
  
• December 16, 1998 - Use of ASRs (In-House Tests) to Monitor HIV/AIDS Drug Therapy
  ASM sent a letter to the FDA's Center for Devices and Radiological Health (CDRH) requesting FDA's assistance in assuring that clinical laboratories will be able to continue using ASRs (in-house tests) to monitor the effectiveness of HIV/AIDS drug therapy in HIV/AIDS patients.

Guidance Documents and Rules

February 26, 2003:  Guidance for Industry Analyte Specific Reagents; Small Entity Compliance Guidance; Guidance for Industry

November 5, 1998 - Analyte Specific Reagents (ASR) Final Rule
Food and Drug Administration Final Rule on Analyte Specific Reagents (ASR) goes into effect on November 23, 1998. The ASM is working with the FDA on an interpretation of this regulation and its impacts on clinical laboratories.