The Regulatory Landscape of Laboratory Developed Tests (LDT): A Laboratorian Perspective

The Regulatory Landscape of Laboratory Developed Tests (LDT): A Laboratorian Perspective

The FDA released a proposed LDT rule and stated it will “end its enforcement discretion” of LDTs. Previously, the FDA explored other avenues for regulating LDTs. We will discuss questions relevant to the draft rule and implications to laboratory medicine, including, but not limited to: - What are possible implications of FDA regulation of LDTs? - Is the FDA the appropriate mechanism for this LDT oversight? - What about modernization of CLIA? - What would be the financial cost? - What would be the diagnostic cost?

MSACL 2023 : A Chat with Jennifer Van Eyk on her Distinguished Contribution Award Lecture

Dustin Bunch chats with Jennifer Van Eyk on the fine points of her Distinguished Contribution Award lecture from the previous evening. Recorded onsite at MSACL 2023 Monterey in the Exhibit Hall.

MSACL 2023 : A Chat with Tim Collier on his Michael S Bereman Award Lecture

Dustin Bunch chats with Tim Collier on some of the nuances of his Michael S Bereman Award for Innovative Clinical Proteomics lecture from the previous afternoon. Recorded onsite at MSACL 2023 Monterey in the Exhibit Hall.

The MetaProteomics Initiative : The Cornerstone of Comprehensive Molecular Analysis of the Microbiome Ecosystem

Through connecting genomic and metabolic information, metaproteomics is an essential approach for understanding how microbiomes function in space and time. The international metaproteomics community is delighted to announce the launch of the Metaproteomics Initiative (www.metaproteomics.org), the goal of which is to promote dissemination of metaproteomics fundamentals, advancements, and applications through collaborative networking in microbiome research.

Paper Spray Mass Spectrometry in Clinical Application

An interview with Lindsey Kirkpatrick, DO, PhD and Nicholas Manicke, PhD discussing the technology behind, and development of, Paper Spray technology, as well as its place in the clinical lab. Read the companion article in JMSACL, Development and validation of a paper spray mass spectrometry method for the rapid quantitation of remdesivir and its active metabolite, GS-441524, in human plasma (https://doi.org/10.1016/j.jmsacl.2022.06.001).