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US Government Places Export Controls on LC-MS Instruments for Top-Down Proteomics

NEW YORK – The US Department of Commerce's Bureau of Industry and Security (BIS) on Wednesday released an interim final rule (IFR) implementing targeted export controls on liquid chromatography-mass spectrometry (LC-MS) instruments "specially designed for top-down proteomic analysis," to China and several other countries.

According to BIS, "evidence suggests certain countries" are using these technologies to develop an "asymmetric military advantage."

The IFR imposes new license requirements for the instruments, and exporting companies will be required to file electronic export information in the automated export system for certain exports. License exceptions will be available for particular destinations, the government said.

BIS did not specify what LC-MS instruments would be covered by the rule. Instruments including Thermo Fisher Scientific's Orbitrap Astral, Bruker's timsTOF line, and Sciex's XenoTOF systems are all commonly used by proteomics researchers, but these instruments are not intended for top-down proteomics specifically. Other vendors including Waters and Agilent Technologies also make instruments that can be used in proteomics research, including top-down proteomics, though their instruments are likewise not targeted specifically at top-down research.

A 2023 study by the Consortium for Top-Down Proteomics compared protocols for top-down proteomics across 11 laboratories. The instruments used were the Waters Synapt and Synapt G2Si, the Thermo Fisher Orbitrap Q-Exactive UHMR and LTQ Orbitrap XL, the Bruker Solarix FTICR, and the Agilent 6545XT SLIM QTOF.

In a note to investors, Wolfe Research analyst Doug Schenkel included comments from Danaher (parent company of Sciex), Agilent, and Waters. Both Waters and Danaher said that given their manufacturing locations and their limited exposure to the top-down proteomics market they did not believe the IFR would meaningfully impact their business. Agilent likewise noted its limited exposure to the top-down market and added that it did not view the IFR as a "ban," but "rather an additional element of the sales process."

Top-down proteomics — which focuses on the analysis of intact proteins — remains a small portion of the overall proteomics market.

The IFR also imposes export controls on high-parameter (26 or more channels) and spectral flow cytometers and cell sorters. Companies including BD Biosciences, Thermo Fisher, and Agilent sell instruments that would fall into these categories.

The IFR takes immediate effect. Public comments on the rule may be submitted for 60 days starting from Jan. 16.