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Agilent Aims to Streamline Clinical Mass Spec With New Launch

NEW YORK – Agilent Technologies is expanding its clinical mass spectrometry offerings with the release of a new class I LC/MS instrument.

Officially released this spring and highlighted this week during the company's virtual press event for the American Society for Mass Spectrometry annual meeting, the instrument, called the Agilent Infinity II Clinical Edition K6460S, is aimed at the laboratory-developed test market and is suited to analysis of small molecules and large-molecule analytes including peptides depending on the sensitivity required, said Sudharshana Seshadri, associate vice president of clinical mass spec at Agilent.

Agilent also said that it had launched the system as a class II device in China, where the system enters that market with approvals for certain assays including hormone, vitamin, and therapeutic drug monitoring tests, Seshadri said.

The platform brings together Agilent's 1260 Infinity II LC with its K6460 triple quadrupole and its MassHunter software to provide an integrated platform for developing and running clinical assays.

Seshadri said this level of integration sets the platform apart from Agilent's previous clinical mass spec offerings.

"When a customer does get it in their lab, they are able to implement it extremely easily," she said. "And I think that is a huge advantage Agilent can provide in this space."

In fact, the industry has in recent years taken significant steps toward making mass spec a turnkey clinical tool similar to immunoanalyzers. Thermo Fisher Scientific has moved the furthest in this direction with the launch of its Cascadion SM Clinical Analyzer, an end-to-end automated mass spec system that the company released in Europe in 2018 and in the US this March.

In 2017, Danaher business Sciex launched its Topaz LC-MS, a simplified and streamlined version of its existing 4500MD LC-MS system. The company has also released an FDA-approved vitamin D test kit for use on the platform.

The Agilent system is more akin to the Topaz in that it is an open platform designed for users to develop their own tests on the system. The Cascadion is a closed platform that only runs tests developed by Thermo Fisher for use on the system. Currently, the company offers one assay, its 25-Hydroxy Vitamin D assay, for the platform.

Unlike Sciex, which is developing test kits for use on the Topaz, Agilent has no near term plans to develop test kits for the platform, Seshadri said.

"Our expertise and our core competency is in driving robust, reliable mass spec, and we are really focused on that and are going to continue to drive that in the near future," she said, though she noted that "across Agilent there are a lot of capabilities that could enable us to go down that path in terms of driving kits and reagents and putting class II solutions together."

The Agilent platform does not move as far in the direction of a turnkey system as the Topaz, let alone the Cascadion, though Seshadri said that like Sciex and Thermo Fisher, Agilent is seeing demand among clinical customers for simpler, more streamlined mass spec instrumentation.

"The way that mass specs in general are today, you need a level of understanding in terms of your method development, your acquisition, your methodology, as well as your data processing," she said. "And this is one of the clear limitations."

Seshadri noted that while test and method development on the Infiniti II Clinical Edition K6460S platform still requires an expert user, users with less expertise can run these methods once they have been developed.

"It allows a med tech to interact with the device in a minimal way and get the results as quickly as possible," she said. "We are progressing in the direction of making this a push button system. We're not quite there yet, but the steps we have taken here get us closer and closer in that direction."

Sciex and Thermo Fisher have not released sales figures for the Topaz or Cascadion. Based on conversations with clinical mass spec experts, neither instrument appears to have seen significant uptake as of yet. Seshadri said, however, that Agilent continues sees demand from its clinical customers for more streamlined mass spec instruments.

"What we are hearing specifically from customers time and time again is the need for simpler, easier to use instruments," she said. "That is the direction that we are going to continue to drive our development in."