Q&A: Taking the measure of ‘omics results in health science and personalized medicine

As part of an effort to increase our attention on advances in analytical instruments and software that contribute directly to the precision, accuracy, speed and ease-of-use for life-science research, this month, DDNews asked Dr. Rohit Khanna, vice president of worldwide marketing for the Waters Division of Waters Corp. (the other division of the company being TA Instruments), to share his views on the advances in mass spectrometry and how they are impacting healthcare delivery.

 

DDNews: Dr. Khanna, what are the most significant challenges health scientists face, and why is mass spectrometry uniquely suited to address them?

 

Rohit Khanna: There is a fundamental change happening in health sciences today—namely that the continued increase in chronic diseases is adding significant burdens to our healthcare system. And while researchers are making significant strides in biomarker research, they are consistently facing challenges when working to translate those findings into clinical applications. There is a bottleneck in the “health science continuum” that is hampering the realization of personalized medicine.

 

At Waters, we believe mass spectrometry is perfectly positioned to address this bottleneck between research and diagnostic test for several reasons. First, MS provides a facile way to do multiplexed analysis measuring multiple analytes (dozens to hundreds) with a single method from a single sample. Second, MS is capable of driving multiple ‘omics studies, such as proteomics, metabolomics and lipidomics (the only thing it can’t analyze is genomics). Third, the advancement of MS selectivity, sensitivity and accessibility is offering scientists a highly versatile and usable tool that has applicability from research to diagnostic testing.

 

DDNews: How are mass spectrometers used in drug discovery and development today? Are there any similarities in how MS is used to identify biomarkers and in diagnostic testing in our march towards personalized medicine?

 

Khanna: Pharmaceutical and biopharmaceutical organizations use MS to characterize new potential therapeutic molecules from early discovery through to quality control and product release. The need to understand the molecular-level attributes of a therapeutic is critical in bringing that product to market. Because a foundational level of analysis is central to the journey of a molecule, we have always seen a high degree of MS analysis take place in the discovery phase of drug development.

 

We are seeing a very similar scenario take place in health sciences. Biomarker discovery is paving the way from the basic science of disease to the development of clinical diagnostics. It is during this early phase of the health science continuum that we are seeing higher uptake of MS use with the follow-on MS methodologies supporting those discoveries all the way through to laboratory-developed tests as well as regulatory-approved tests.

 

DDNews: What advances in mass spec technology have recently been introduced that make the instruments more well suited to drug discovery and development?

 

Khanna: As I mentioned, MS has seen some significant advances in its selectivity, sensitivity and accessibility over the last few years. Its ability to help multiplexed analysis measuring multiple analytes with a single method from a single sample also has the potential to dramatically accelerate the rate of biomarker discovery and broaden our knowledge of how our genetic code and environmental factors interact. Take phenomes—the intersection of where people’s genes and environment meet—as an example. Studying the phenome will help determine how environment and genes combine to affect biochemical processes that lead to disease. Today’s mass spectrometers are giving researchers the ability to study the phenome on an industrial scale, producing a complete and accurate biological readout of thousands of desired analytes at a time, meaning that researchers can pick apart the complex circumstances of conditions like cancer, diabetes and heart disease.

 

Another example of innovation in MS applications is that Waters recently acquired REIMS (Rapid Evaporative Ionization Mass Spectrometry) technology, which has been investigated in microbiology and clinical diagnostic applications. The enabling technology for an early conceptual-stage analytical system called “iKnife”—short for intelligent knife—REIMS is so powerful that it essentially enables analysis of metabolites from vaporized tissue released by an electrosurgical blade.

 

DDNews: How important have advances in ease-of-use been?

 

Khanna: Very. Once limited to only the most highly trained experts, today’s mass spectrometers are automated, easy to use and fit into the current workflow seamlessly while improving performance throughout the drug development process. They now feature easy-to-learn, intuitive processes that are flexible and based on how researchers and clinical lab scientists work, with a highly visual interface to give users confidence in their data. They are also now uniquely able to perform a range of ‘omics studies such as proteomics, metabolomics, lipidomics and phenomics.

 

DDNews: Can you tell us more about REIMS technology and iKnife and how it may be able to analyze a sample in real-time during surgery?

 

Khanna: As mentioned, REIMS is an ionization technique that can be used as a source for direct analysis of samples by mass spectrometry. The transient nature of the REIMS signals is ideally suited for Waters’ time-of-flight mass spectrometers. It is the enabling technology behind the intelligent knife, or iKnife, a device in the conceptual stages of development that could potentially be used for real-time diagnostics in surgery. What it does is use electricity to cauterize surgical incisions as they are made. This process will create a “smoke” which can then be analyzed through MS to determine the nature of what is being cut.

To date, no regulatory approvals have been sought for this device. However, the implications of this process are huge. For example, in tumor surgery, current approaches to sourcing samples for MS analysis require either chemicals or high voltages, both of which are risky for in-vivo analysis due to the potential damage to the patient. It may also take about 30 minutes for the lab to send back the results. REIMS allows MS analysis direct-from-sample and promises to enable real-time sample diagnosis for the first time.

 

DDNews: What is Waters’ vision for the future of health-science discoveries as they relate to MS instrumentation?

 

Khanna: Waters has a long history of providing advanced analytical technologies for life-science and clinical applications. Our partnerships with world-leading life-science researchers in proteomics, metabolomics, lipidomics and phenomics are well documented. Waters was the first LC/MS company to achieve ISO 13485 medical device registration (2005) and the first and still only to develop a U.S. FDA-cleared LC/MS reagent kit (tacrolimus analysis in 2007).

 

But, as noted, we believe there is a fundamental change happening in health sciences, and Waters is committed to evolving and strengthening our technology position within health sciences to address those challenges—whether through technology acquisitions such as REIMS, or our recent agreement with Prosolia Inc.* for the exclusive rights to desorption electrospray ionization technology in clinical applications. Both direct-from-sample ion source technologies are strategic discriminators and key components in our burgeoning heath-sciences initiative as we look to grow the impact of mass spectrometry throughout the health sciences continuum.

 

In 1981, Khanna co-founded Dynamic Solutions, a California-based software-engineering firm dedicated to providing personal workstations to the scientific and engineering community for use in analytical instrumentation, process monitoring and control and automated test and measurement applications. His company’s PC-based data management software product, Maxima, was a leader in transitioning the analytical instrument industry to automated system control and data analysis. Dynamic Solutions was acquired by Waters Corp. in 1986.

 

Khanna then transferred to Waters’ corporate offices to manage the company’s successful data product business, including the development of the Millennium—now Empower—chromatography data software product lines.

 

In 1995, Khanna became vice president of customer assurance, with responsibility for Waters’ service and support business. Under his leadership, business unit revenue grew nearly threefold, and Waters drove an overall strategy of ensuring customer success through the Connections program brand.

 

Upon his appointment to vice president of worldwide marketing in 2002, Khanna assumed responsibility for driving product direction, market development, brand and product management and marketing communications, in addition to his continuing responsibility for managing the customer assurance business. More recently, Khanna has also taken on responsibility for managing the newly structured informatics business consisting of software for liquid chromatography, mass spectrometry, electronic records management and electronic laboratory notebook management.

 

In 1991, Purdue University named Khanna one of its Outstanding Chemical Engineering Alumni.

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*DDNews commentator Peter T. Kissinger serves as a director with Prosolia Inc.