ASM joined members of the Clinical Laboratory Coalition in a letter to House and Senate committee leadership on the Diagnostic Accuracy and Innovation Act (DAIA) discussion draft.

Marc Couturier and Laura Filkins, members of the PSAB Committee on Laboratory Practices, authored a document entitled “Cyclospora Detection and Reporting from Clinical Samples” to assist our members in identifying a parasite which has been on the rise in intestinal illnesses.  Cyclospora is not usually detected by a conventional O&P examination but can be detected using modified stains, which are detailed in the document.

Effective October 14, 2016, the Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HSS) added great ape pathogen Bacillus cereus biovar anthracis as a Tier 1 select agent to the list of select agents and toxins.  This white paper provides information about this organism and suggests ways to identify it.

ASM submitted comments to CMS on payment for new codes which will be included in the 2018 Medicare Clinical Laboratory Fee Schedule (CLFS). New codes considered included detection of antibiotic resistance genes and new antibody and PCR tests for Zika.

Christopher Doern and Duane Newton, members of the Public and Scientific Affairs Board, Laboratory Practices Committee authored the white paper “Clinical Utility of Multiplex Tests for Respiratory and Gastrointestinal Pathogens.”  The expanded availability of molecular methods for detection of pathogens directly in clinical specimens is changing the paradigm for diagnosis and management of patients with infectious diseases.  This paper describes the benefits and clinical value of multiplex molecular diagnostic panels. 

ASM joined the Infectious Diseases Society of America (IDSA) and the Pan American Society for Clinical Virology (PASCV) in drafting comments for the draft Diagnostic Accuracy and Innovation Act (DAIA) legislation.  The DAIA builds upon previous efforts to establish a new framework for the regulation of both in vitro diagnostic tests and laboratory-developed tests (LDTs).

ASM and the Pan American Society of Clinical Virology (PASCV) drafted a letter expressing concerns about the turnaround time for results in the Zika plaque reduction neutralizing test (PRNT) currently available and suggested some solutions.