AMSTERDAM, Oct. 21, 2016 /PRNewswire/ -- Royal Philips
(NYSE: PHG, AEX: PHIA) today announced the successful completion of
its well-controlled, multicenter pivotal validation study designed
to compare diagnoses determined by pathologists from digital whole
slide imaging to traditional optical diagnoses through a
microscope. The study, which examined the viewing, reviewing and
diagnosing of surgical pathology tissue slides from a range of
tissues met its pre-specified endpoint.
In the U.S., the Philips IntelliSite Digital Pathology Solution
is presently cleared as an aid to the pathologist in the detection
of HER2/neu. The newly completed clinical validation study by
Philips will be submitted to the FDA, with other data and
information, in support of a de novo submission that, if cleared by
the FDA, would result in expanded indications for
use.
"Philips is committed to working alongside regulators and
pathologists to better understand and evaluate the clinical
validity of this technology," said Russell
Granzow, General Manager, Philips Digital Pathology
Solutions. "I wish to thank our clinical partner sites for their
diligence during this seminal study."
In one of the largest studies ever conducted to directly compare
the use of digital pathology to optical microscopes, 16
pathologists at four clinical study sites – Cleveland Clinic,
University of Virginia, Miraca Life
Sciences and Advanced Pathology Associates – conducted
approximately 16,000 reads across 2,000 cases.
The non-inferiority study was designed to evaluate the
difference in major discordance rates between diagnoses made with
digital pathology or microscope. To measure this, the study had
pathologists read slides obtained from cases at least one year old
for which a main diagnosis was available. With this existing
diagnosis serving as the point of comparison, pathologists then
read and diagnosed each case both digitally and optically with a
washout period of four weeks in between. The pre-specified endpoint
for the primary analysis of this study was set on a maximum of four
percent difference in major discordance rates. This study endpoint
successfully achieved the acceptance criterion with a final
discordance rate of outcome of the study being only one
percent.
"Pathology is a subjective field that is dependent on how the
eye of each pathologist views what appears in the microscope.
Defining how to measure and assess just how this process compares
to a digital reading is complex," said Dr. Clive Taylor, the principal investigator. "The
design of this study holds the original diagnosis to be the truth
and that provides us with a base to compare all readings by all
pathologists in the study."
"Proving that digital reads are not inferior to optical reads
creates a foundation for a FDA submission that, if cleared, would
allow for the shift to a digital operation that, in turn, may reap
the additional benefits of collaboration, workflow efficiency and
the use of precise tools for measurement and counting," adds Dr.
Michael Feldman.
Philips IntelliSite digital pathology solution is an open
platform that integrates ultra-fast slide scanners, an image
management system and web based pathology case viewer. To learn
more about Philips' innovation in digital pathology, visit Philips
Digital Pathology Solutions website and follow @Philips_Path.
* In the European Union, the Philips IntelliSite Pathology
Solution is CE Marked under the European Union's 'In Vitro
Diagnostics Directive' for in vitro diagnostic use. In Canada, the Philips IntelliSite Pathology
Solution is licensed by Health Canada for in vitro diagnostic
use. In the United States, the
Philips IntelliSite Pathology Solution is indicated for in vitro
diagnostic use for Manual Read of
the Digital HER2 Application. The Philips IntelliSite Pathology
Solution is registered for in vitro diagnostic use in Australia, New
Zealand, Singapore and the
Middle East.
For further information, please contact:
Hans Driessen
Philips Digital Pathology Solutions
Tel: +31 6 10610417
E-mail: hans.driessen@philips.com
About Royal Philips
Royal Philips (NYSE: PHG, AEX: PHIA)
is a leading health technology company focused on improving
people's health and enabling better outcomes across the health
continuum from healthy living and prevention, to diagnosis,
treatment and home care. Philips leverages advanced technology and
deep clinical and consumer insights to deliver integrated
solutions. The company is a leader in diagnostic imaging,
image-guided therapy, patient monitoring and health informatics, as
well as in consumer health and home care. Headquartered in
the Netherlands, Philips' health
technology portfolio generated 2015 sales of EUR 16.8 billion and employs approximately 69,000
employees with sales and services in more than 100 countries. News
about Philips can be found at www.philips.com/newscenter.
Photo - http://photos.prnewswire.com/prnh/20161021/431262
Logo -
http://photos.prnewswire.com/prnh/20140122/NE50581LOGO
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/multi-center-clinical-validation-study-by-philips-to-be-submitted-to-fda-in-support-of-expanded-indications-for-use-for-philips-intellisite-digital-pathology-solution-in-the-us-300349160.html
SOURCE Royal Philips