February 21, 2017
By Kristi Birch
A startup company, Rad/Path Solutions LLC, is set to manufacture a novel device that could improve breast cancer detection, while also reducing the number of false positives by up to 25 percent.
The device, a new tissue tray used to store and analyze biopsied breast tissue, is the brainchild of Ossama Tawfik, M.D., Ph.D., professor of pathology and director of the Image Analysis and Digital Pathology Laboratory at the University of Kansas Medical Center. Tawfik, chief medical officer at Rad/Path Solutions, wanted to improve the communication between radiologists and pathologists, critical for accurate diagnoses. "Right now, radiologists and pathologists operate in silos," said Tawfik. "Unlike The University of Kansas Hospital, many hospitals do not have an integrated approach and that can cause mistakes. Thousands of breast cancer diagnoses get missed every year, and we have to break that cycle."
Nearly 40 million mammograms are done each year in the United States; more than 1 million of which lead to radiology-guided biopsies. After a mammogram indicates lesions and additional imaging confirms them, a radiologist biopsies the tissue, X-rays the specimens to make sure they contain the lesions, places the tissue samples into a generic cassette and then into liquid preservative in a jar before shipping them to the pathologist.
The problem? Not only can the tissue be damaged en route, the pathologist often cannot be sure which parts of the tissue floating in the jar correspond to the lesions discovered on the mammogram. After removing the samples, embedding them in wax and analyzing them histologically, the pathologist sometimes must send blocks of tissue back to radiology for new X-rays to correlate the findings. Improper correlation between imaging and pathology can result in missed diagnoses as well as false negatives, delayed detection of malignancies and failure to flag high-risk, pre-malignant lesions that should be monitored.
Rad/Path's Tissue Trays reduce the opportunities for error and discrepancies by enabling pathologists to study their findings simultaneously alongside those of the radiologist. These plexiglass-based trays have four slots, like drawers for silverware. The radiologist lays the individual tissue samples into the separate slots, X-rays the tray, marks on the X-ray where the lesions are and then secures the tray in the generic cassette to ship it. When the pathologist receives the tray, he can then analyze the samples in exactly the same position they were in when they were imaged, and in conjunction with the X-ray.
Rad/Path Solutions LLC licensed the tissue tray technology from the University of Kansas Medical Center in July 2016. A patent was issued last year. After the tray is approved by the Food and Drug Administration, the company plans to manufacture the trays in Minnesota, where Rad/Path Solutions is based, and then distribute them. The trays withstand all types of solvents utilized in laboratories for tissue processing and could eventually be modified for use with biopsies of other kinds of tissue.
This systemically integrated approach becomes even more critical as health care delivery happens less in major medical centers and more in community settings, where pathologists and radiologists are not under the same roof. "Here at KU, we-radiology and pathology-have a conference once a week where we go back and forth about specimens," notes Marc Inciardi, M.D., a radiologist at the University of Kansas Health System who participated in early tests of Tawfik's prototype. "But this does not happen much outside an academic facility. Anything that can be done to enable good communication and good correlation is important."
Not only do the trays have the potential to save lives, but they can also help reduce costs. The Institute of Medicine has estimated the price of medical errors, both in terms of health care costs and lost productivity and income, to be between $17 and $29 billion a year.
"This is an excellent example of bringing a practical, innovative product idea, developed by practicing clinical faculty, to the market to fulfill a critical need," said Rajiv K. Kulkarni, Ph.D., M.B.A, CLP, director of Technology Commercialization, KU Innovation and Collaboration. "This device may potentially be used to analyze biopsies of all types of solid tumors."