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May 2016
PATIENT CARE AND SCIENCE
Proposed Regulations for LDTs: IDSA Expresses Concerns
The Food and Drug Administration (FDA)’s proposed guidance to regulate laboratory developed tests (LDTs) will impact many tests ID physicians rely on to identify the cause of infection and guide treatment selection. IDSA, along with the American Society for Microbiology (ASM) and the Pan-American Society for Clinical Virology (PASCV), published a joint policy paper on ID LDTs in Clinical Infectious Diseases to reiterate concerns with the guidance and offer recommendations to minimize the disruption of patient access to these important tests. 
 
In response to IDSA concerns that diagnostics for transplant-associated viruses in particular will be impacted severely by the LDT guidance, the FDA expressed an interest in holding an expert panel meeting devoted to discussing viral load testing to transplant-associated opportunistic viral infections. IDSA enthusiastically supports this meeting and hopes it will address the evidence of risk posed by these tests and their measures to mitigate this risk. IDSA responded with a letter with peer-reviewed evidence on the use of viral load testing to transplant viruses to support the FDA’s planning process and also offered suggested subject matter experts to serve on the panel.


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PATIENT CARE AND SCIENCE
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Proposed Regulations for LDTs: IDSA Expresses Concerns
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Journal Club
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