Applying principals of analytic chemistry to advance value of histopathology
In Bergamo, Italy, a vision of “patient first” anatomic pathology is under construction in a unique way. At the corporate headquarters of Milestone Medical, Founder, President and self styled “Chief Dreamer” Franco Visinoni is actively investing to develop pre-analytical tools and products specifically designed to support same day—or faster—diagnoses by pathologists.
This week, your Dark Daily Editor Robert L. Michel visited Visinoni in Bergamo to learn, first-hand, about this company which has a rather low profile in the United States.
Founded in 1988 by Visinoni, who is an analytical chemist, Milestone’s core competency is in “advanced microwave instrumentation for analytical and organic chemistry labs.” Milestone has an installed base of more than 13,000 systems. It counts as customers more than 70% of the Fortune 500 companies, along with universities and many research institutions. It was 1994 when Milestone entered the medical market by using its experience in laboratory-grade microwaves to develop the first microwave tissue processors specifically designed for use in histopathology. The company’s web site claims that its installed base of hundreds of these systems makes them “the most widely used microwave processors in the field.” It holds certification under ISO 9001:2008.
DATELINE: BERGAMO, ITALY—(L) Franco Visinoni, President of Milestone, greets Dark Daily Editor Robert L. Michel Wednesday for a full day site visit and strategic exchange on opportunities in the pre-analytical stage of histopathology operations.
That short description sets up the interesting insights shared during my site visit to Bergamo. Visinoni, who holds numerous patents for his inventions, is enthusiastic about the future of histopathology. “This is an exciting time for the pathology profession,” he stated. “Rapid advances in many scientific fields make it possible to create new solutions across the entire spectrum of activities in the histology laboratory and anatomic pathology,” declared Visinoni. “Pathologists will be able to diagnose disease with more precision and in less time.
“My vision is a ‘patient first’ pathology service,” he continued. “At Milestone, we emphasize that every specimen and each slide represents an individual patient who deserves a precise diagnosis, delivered the same day or within hours of collecting the specimen. As pathologists achieve this goal, they will be delivering a very valuable service that moves pathology away from a commodity and makes a highly-valuable, personalized clinical service to the patient and the referring physician.”
It is the next part of Visinoni’s vision that will intrigue many pathologists. With his background in analytical chemistry, Visinoni believes that the precise scientific formula specifications used in analytical/clinical chemistry and immunochemistry testing can be inspiration to create similar formulas in histology processing. These formulations could be applied in histology as specimens are transfered to the histopathology laboratory, processed, and turned into slides. “Many of today’s common practices in prepping and processing tissue specimens can benefit from a more performance-based process—a protocol with tight tolerances that reduces variability in how tissue is processed within a laboratory, as well as across different laboratories,” observed Visinoni.
“It is our objective to use new technologies to create integrated work flow and automated systems that achieve three outcomes,” he continued:
- “One, use of integrated automated solutions to reduce or eliminate sources of errors in the pre-analytical stage. This starts when a tissue specimen is collected and sent on its way to the laboratory until slides are produced from that tissue.
- “Two, to eliminate the use of formalin and other toxic chemicals commonly used in processing tissue, with two important benefits. First is the improved safety of histotechnologists and the lab staff who currently must work around these chemicals. Second is to process specimens in a way that allows them to be used for immediate or later molecular analysis; and,
- “Three, to create the ability for a histopathology laboratory to rapidly process tissue so that the pathologist can diagnose and report results that same day—or even within a few hours of the specimen reaching the laboratory. This speedy time to diagnosis is what I believe will create substantial value for anatomic pathologists. After all, an accurate and fast diagnosis gives patients a peace of mind that they have a definite answer without having to wait several days or even weeks.”
These are ambitious objectives for improving histopathology pre-analytical processes. The development team at Milestone is applying the rigorous mindset of analytical chemistry that it has used for more than two decades to develop systems used in a broad swath of industries outside of medicine. This may turn out to be a trump card for Milestone. Were it to significantly reduce errors in pre-analytical tissue handling procedures while speeding up processing time needed to produce finished slides, it would achieve its “patient first” goal while also raising the value proposition of anatomic pathologists.
This Dark Daily-briefing does not do full justice to the vision of Franco Visinoni and his passion for bringing new capabilities to histology pre-analytical work flow. Count on both Dark Daily and The Dark Report to provide further insights about this effort.
Your editor is now traveling on to Florence, Italy to do a presentation at the 22nd Annual European Congress of Pathology, which meets from September 4-9, 2009. Look for up-to-the minute intelligence briefings on new developments in anatomic pathology on this side of the Atlantic.
Robert L. Michel
Editor, Dark Daily