Can vendors use the word "telepathology" in marketing materials? Few do out of concern due to lack of FDA clearance for the scanning device. Companies based overseas are particularly reluctant and dare say the term. Even some of the newer vendors to the space are careful to point out that their devices are for "research purposes only" and disclaimers to the effect that the devices have not been cleared by the FDA for primary interpretation are nearly universal among vendors.
So, manufacturers do not make a claim that their device can be used for primary H&E reads.
"AccelPath LLC (Westwood, MA) has partnered with the in-office lab consulting firm Triangle Biomedical Sciences (TBS-Durham, NC) and begun marketing digital pathology services to urology, gastroenterology and dermatology groups. Under the partnership, TBS will help specialty groups build in-office labs and AccelPath will install digital slide scanners. Digitized slide images will be sent electronically to AccelPath, which has contracted with the Pathology Department at the Lahey Clinic (Burlington, MA) for professional interpretations."
On AccelPath's website they mention specifically "primary interpretations" as one of the many uses with these added value propositions:
- Eliminate the cost, delays and logistics of shipping slides and blocks
- Eliminate the need to recruit, hire and retain pathologists
- Enjoy full access to AccelPath's prestigious team of U.S. based pathologists
- Receive fastest slide-to-report service
- Obtain 24/7 access to digital archives of all reports, requisitions and images
- Maintain control by keeping all slides on site at all times
- Implement our program easily with support from trained professionals
All of this is both encouraging and a real threat with continued commoditization of pathology services.
Laboratory Economics notes that the transaction has created the first publicly-traded company focused on two key trends in anatomic pathology (i.e., digital pathology and in-office histology labs).
This means clinicians in-source histology for the technical component and out-source the professional component in lieu of an in-office pathologist or local pathology group.
Apparently, they are comfortable with primary reads although I am not clear what scanner(s) are being used and how they have addressed the issue. Presumably they have validated the technology internally and are confident in their ability to offer fast, accurate diagnoses.
The encouraging part is that this marriage between in-office labs and digital pathology with a validated system allows for other groups to replicate the model whether it is a local GI group who is going to bring histology "in house" to referring work to other pathologists from primary laboratories for primary reads. Unmanned pathology shops with 24/7 MD support.
This may provide a completely legitimate way for pathologists to try to "get back" work that has been "lost" to in-office labs with medical director oversight of the laboratory and a TC/PC arrangement where the parties involved get paid for what they are doing rather than having employed pathologists who may not see the full PC for work that he/she has done.
Is this a threat or opportunity for pathology?
AccelPath was formed in October 2008 by Shekhar Wadekar, PhD, chief executive, and H. Lance Evans, MD, head of medical affairs. Wadekar has a PhD in engineering from the University of Delaware and an MBA from New York University. Evans is a board-certified pathologist and practiced hematopathology at Impath (now part of LabCorp/Genzyme Genetics).
AccelPath was recently acquired by Technest Holdings Inc. (Bethesda, MD). Technest is a penny-stock company that trades on the OTC Bulletin Board at a current price of about 8 cents per share (as of March 15). Technest issued 86 million shares valued at roughly $6.5 million to purchase AccelPath. As a result of this reverse-buyout transaction, AccelPath members now own approximately 72.5% of Technest and Wadekar has become chief executive.