Faster results less complexity with Roche cobas mass spectrometry

My name is Donald Mason. I'm the Senior Marketing Manager for Mass Spectrometry at Roche Diagnostics in the United States.

Mass spectrometry is a powerful analytical technology. It is sought after for its selectivity, sensitivity, and its ability to deliver gold-standard results. It has demonstrated clinical value in the fields of therapeutic drug monitoring, endocrinology, and clinical toxicology. For these reasons, mass spectrometry is sought after for routine clinical lab testing.

Mass spectrometry has sat at the periphery of laboratory medicine for nearly three decades, primarily because of its operational complexity, the need for skilled staff, and the lack of a commercial solution.

The cobas Mass Spec solution was designed for routine use in the core clinical chemistry laboratory. It is a part of the cobas pro family of instruments. It's designed to be operated by today's clinical laboratory staff, as opposed to the need for mass spectrometrists.

The cobas^® pro i 601 analyzer is designed to measure most clinically relevant sample types, including urine, serum, plasma, and whole blood hemolysate. Each of our Ionify assays will be specific for the most relevant clinical sample type. For instance, the Ionify estradiol assay is designed to be used with both serum and plasma samples.

There are currently seven assays that are available for use on the cobas^® pro i 601 analyzer in the United States. These include estradiol, progesterone, 17-hydroxyprogesterone, DHEA, DHEAS, androstenedione, and total 25-hydroxyvitamin D.

Roche maintains a robust pipeline of assays that are in development in the United States, many of which are working their way through the US FDA for approval as we speak.

Our customers are reporting a dramatic improvement in turnaround time and a dramatic decrease in hands-on time. A recently published study highlighted a nearly sevenfold decrease in turnaround time and a nearly 20-fold decrease in hands-on time for their staff.

Importantly, this was not for a single analyte, but rather for a panel of six clinically relevant analytes, resulting in a process that is scalable regardless of the number of tests or number of samples that are being analyzed.

I expect the introduction of mass spectrometry to the core clinical lab to shape the market in a way similar to the introduction of automated immunoassays in the market, bringing this powerful technology to more physicians and the patients that they serve.

The cobas Mass Spec solution is designed for the core clinical chemistry lab. The seven assays that are currently approved for use in the United States have achieved a CLIA categorization of moderate complexity, which is the first for any mass spectrometry-based testing.

How does the cobas^® i 601 analyzer improve clinical mass spectrometry workflows in routine laboratories?

The cobas^® i 601 analyzer is designed for routine use in core clinical laboratories, enabling broader adoption of mass spectrometry. It delivers a nearly sevenfold reduction in turnaround time and a nearly 20-fold decrease in hands-on time across six clinically relevant analytes, helping laboratories expand access to high-quality testing for clinicians and patients.

What benefits does automated LC-MS/MS from Roche Diagnostics offer to clinical laboratories and patients?

Roche Diagnostics’ mass spectrometry solution, including the cobas^® i 601 analyzer, helps bring automated LC-MS/MS closer to routine clinical testing. By significantly reducing turnaround and hands-on time, laboratories can offer more selective and sensitive testing, improving access to high-quality results for clinicians and patients while supporting today’s laboratory staff.

How is Roche Diagnostics advancing routine clinical mass spectrometry according to Donald Mason?

Donald Mason, Senior Marketing Manager for Mass Spectrometry at Roche Diagnostics, explains that the cobas^® i 601 analyzer helps overcome long-standing challenges of bringing mass spectrometry into routine clinical laboratories. This shift expands access to one of the most selective and sensitive analytical technologies, benefiting more laboratories, clinicians, and patients through improved efficiency and high-quality testing.