Histolix Team Receives Additional $3.2 Million Funding for Revolutionary Direct-to-Digital Read Pathology Solution Development
Sacramento, CA (PRWEB) June 28, 2023 -- The University of California, Davis (UCD) founding team of Histolix, a leading developer of direct-to-digital read pathology solutions, recently received $3.2 million funding from the National Cancer Institute (NCI) for further evaluation of its Giga Fluorescence Imitating Brightfield Imaging (FIBI). The latest grant brings the total of funding awarded to the Histolix founding team to $9 million from the NCI and National Institute of Health (NIH) over the past 12 months. The development effort of this revolutionary new histological methodology is being led by renowned UCD experts Richard Levenson, MD and Farzad Fereidouni, PhD. The team’s focus is on rapid high quality digital histologic imaging of freshly excised breast lumpectomies to enable pathologists to provide intraoperative guidance to the breast surgeon.
“We believe Histolix could reduce or eliminate breast lumpectomy re-excision procedures resulting from inadequate margin analysis by current technologies. Today, 25 percent of women are found to have incomplete cancer excision and need to have a second surgery,” said Rob Royea, president and CEO, Histolix. “A radically improved procedure needs to be deployed. This is the Histolix Giga FIBI solution.”
Royea continued, “Giga FIBI’s direct-to-digital pathology technology could ensure consistently accurate breast excision margin determination. As the NCI noted, the investigative team is one of the best in the country to attempt such an effort, with highly relevant experience developing exactly these kinds of microscopes.”
In addition to Fereidouni and Levenson, Histolix chief technology officer and chief science officer respectively, the investigative team is comprised of leading healthcare researchers, Alexander “Sandy” Borowsky, MD; Candice Sauder, MD and Diana Miglioretti, PhD. Currently, there is no highly sensitive solution to solve this problem, resulting in weeks of anxiety for the patient with eventual call back for repeateded procedures. The only rapid way for tissue assessment at the time of surgery is Frozen Sectioning (FS). Due to the difficulty in processing the mixed adipose tissue of the breast and the possibility of loss of diagnostic tissue, as well as the wide area that must be evaluated, frozen sectioning for breast lumpectomy margins is considered infeasible and is not the standard of care. The standard of care is permanent section requiring overnight processing.
“Residual tumor left after breast cancer surgery is a persistent concern due to its association with cancer recurrence, need for additional surgery, potential to cause patient anxiety and risk for poor outcomes,” said Borowsky, chief medical officer for Histolix and professor of Pathology and Medicine, UCD. “Now, I can utilize Giga FIBI to advise our surgical colleagues about breast excision margins in time to modify the procedure and obtain clear margins. To do this with today’s technology would take over an hour and is prone to error. With this new digital technology, however, we are able to do this in minutes with high accuracy, while the patient is in the operating room.”
Digital Pathology (DP) has been FDA approved for several years, but has had disappointing adoption (under 10 percent). Current DP still require slides to be made, not improving on historical labor-intensive, costly processes, and only then can DP be introduced to digitize the whole slide image. Histolix eliminates virtually all of the historic process and time constraints by creating a digital image without the slide at the point-of-care.
“Here, we offer a new imaging strategy that can provide real-time feedback to the surgical team during the operation, as opposed to post surgery analysis after the surgery has ended,” said Royea. “Histolix is positioned to convert today’s digital pathology usage from seven to 100 percent adoption for diagnosis. We also can empower AI tools now at the point of surgery, potentially accelerating treatment bedside at the time of diagnosis, versus waiting weeks for additional analysis.”
The overall global pathology market is immense and is expected to have a compounded annual growth rate (CAGR) of 18.1 percent from 2023-2032, resulting in a total of $114.5 billion in 2032. Histolix direct-to-digital read from fresh tissue across multiple tissue types has the potential to replace a sizable percentage of current pathology processes while significantly decreasing headcount and tissue handling cost, along with the possible elimination of up to 30 percent of non-necessary repeated surgical procedures.
About Histolix
Histolix patented technology provides a new intrinsically digital slide-free histopathology solution that is deployable in both pathology labs as well as clinician-focused point-of-care settings, eliminating delays from current pathology workflow. Supported by millions in grant and private funding with three years of development completed, Histolix has licensed its patented “direct read” technology from University of California, Davis. In coordination with the founding team, Histolix recently concluded a 100-tissue sample equivalency validation study across multiple tissue types, resulting in no major discordance with conventional FFPE pathology standards. For further information, visit http://www.histolix.com.
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Laurie Hallwyler, Histolix, http://Histolix, 1 6502489081, [email protected]
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