In the May 31 issue, IBO detailed Thermo Fisher Scientific’s annual analyst day (see IBO 5/31/17). At the event, the company revealed it was at work on a dedicated clinical MS system. This week, Thermo Fisher previewed the Thermo Scientific Cascadion SM Clinical Analyzer at the EuroMedLab conference. Calling it “the first all-in-one LC-MS/MS solution designed to meet the needs of clinical laboratories,” the system is set to receive EU CE marking next year and will be released in the US once it is FDA approved as a Class I medical device.

Thermo Fisher also plans to launch three kits specifically designed for the system, following FDA 510(k) approval. The first kits will be for 25OH vitamin D, total testosterone and immunosuppressant drugs. Other kits are expected to follow and may include kits for drugs of abuse and endocrinology.

“The instrument is pivotal to the system, but as essential are the additional items that we are designing, manufacturing and validating for use on the instrument.”

“There hasn’t been [an LC-MS/MS] platform that’s really designed specifically for the clinical lab,” said Robert S DeWitte, PhD, vice president, Research and Development, and vice president, Clinical Mass Spectrometry, at Thermo Fisher, in an interview with IBO. Dr. DeWitte emphasized the differences between how LC-MS/MS is currently used in some clinical labs but does not meet the needs of most clinical labs. “The clinical laboratories are really designed nowadays around turnaround time and single-piece flow, and the instruments themselves are all random-access instruments—that’s the mainstream core chemistry lab.”

Barriers to adoption of LC-MS/MS by clinical labs on which Thermo Fisher focused in developing the Cascadion SM were: regulatory, quality (e.g., variability from lab to lab), resources (e.g., operator skills) and workflow (e.g., turnaround time). “This system is comprehensive: sample in, result out. For mass spectrometry, that has not been done,” noted Dr. DeWitte. The integrated system, which resembles a standard clinical chemistry analyzer in size and appearance, consists of the automated Thermo Scientific TurboFlow online sample preparation technology, a newly designed LC based on the Prelude MD HPLC system, a newly designed MS system based on the TSQ Altis Triple Quadrupole MS, and dedicated software. Among the system’s innovations are a quick-connect cartridge and spring-loaded clamp for easy and fast changing of analytical columns. Another innovation is random-access loading, which reduced turnaround time in contrast with current LC/MS systems used for clinical applications that require sample batching.

“I really want to emphasize this is a system and not an instrument,” added Dr. DeWitte. “The instrument is pivotal to the system, but as essential are the additional items that we are designing, manufacturing and validating for use on the instrument.” These include reagents with internal standards, calibrating controls for each of the assays, a set of consumables (e.g., solvents) and disposables. “All of these materials are standardized. They all come prepared and ready to use from us,” he said, thus providing a standardized solution.

Although Dr. DeWitte said he could not comment on the performance requirements of the system, as it is pending regulatory approval, he did highlight the turnaround times as being on par with current clinical immunoassay systems, which is the primary technology competitor for LC/MS in hospital labs. “Immunoassay analyzers that are in the clinical core labs: the sort of performance they have are a time to result of 15–25 minutes for each sample. They are random-access immunoassay analyzers, and our cycles are right in line with those performance characteristics.”

Cascadion SM is a closed system, and therefore cannot be used with LDTs. Explaining the advantages of this, Dr. DeWitte said, “Getting to quality is all about variability. So a great amount of the design is taking variability out of the laboratory and moving it into the factory.” In this way, standardization is built into the entire solution, from calibration to software. For example, with Thermo Fisher developing and manufacturing the assays, knowing the sample types and using a fixed system design, the software can be standardized to meet the requirements of any clinical lab.

The Cascadion SM Clinical Analyzer will be featured at the annual American Association for Clinical Chemistry conference held in August, in San Diego, California.