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I was pleased to see Histolix concordance fall within and be even better than the FDA guidelines for approval of DP for primary pathology diagnosis
DAVIS, Calif. (PRWEB)
April 05, 2022
Histolix, a leading developer of direct-to-digital read pathology solutions, recently published the results of its Fluorescence Imitating Brightfield Imaging (FIBI) equivalency study to the standard Formalin-fixed and Paraffin-embedded (FFPE) conventional pathology methodology. The study showed no major discordance between the two methodologies, which could enable significant time savings in providing rapid and accurate pathological analysis. This breakthrough advance could reduce such analysis time from the current eight hours or more for completion to under 10 minutes.
“The impact the Histolix direct-to-digital read solution could have on workflow and, most importantly, patient care would be extremely significant,” said Rob Royea, president and CEO of Histolix. “For example, the Histolix solution could result in a major impact for eliminating those unnecessary 15-20 percent of core biopsy and breast lumpectomy re-surgical procedures, which occur today. As the Histolix technology is intrinsically digital, we could enable AI molecular assessment directly from fresh tissue, prior to pathology assessment, while in parallel preserving tissue for downstream molecular, DNA and RNA analysis.”
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 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.
To demonstrate efficacy of its novel approach to pathological analysis, Histolix conducted an equivalency validation study, in parallel with FDA study standards for DP, and proved FDA level diagnostic concordance through four expert third party readers and 800 reads of 22 tissue types. The study was based on patented technology developed by leading pathologists from the University of California (UC), Davis, who also led the equivalency evaluation.
“I led the Leica digital pathology trial for showing non-inferiority to traditional microscopy. The Histolix study uses the same study design,” said Alexander Borowsky, MD, professor of Pathology and Medicine at UC Davis and chief medical officer for Histolix. “I was pleased to see Histolix concordance fall within and be even better than the FDA guidelines for approval of DP for primary pathology diagnosis.”
In the study, the combined category, concordance or minor discordance, was scored as “no major discordance.” The overall agreement rate (compared to the reference diagnosis) across 800 reads, was 97.9%. This consisted of 400 FIBI reads at 97.0 percent versus reference and 400 Hematoxylin and Eosin stain (H&E) reads versus reference at 98.8 percent.
The company’s direct-to-digital read solution is designed to reduce today’s labor-intensive slide-based pathology slide preparation and reads. Along with UC Davis, Histolix has patented its direct-to-digital pathology image from fresh (and fixed) tissue at the point-of-care, positively impacting immediacy of diagnosis, treatment and delayed care as well as historically imbedded cost of whole slide imaging (WSI) with DP.
“It is our intent to pursue FDA clearance for rapid onsite evaluation (ROSE), breast lumpectomy and replacement of frozen section processing leading to commercialization within 18 to 24 months,” said Royea. “With today’s embedded cost of whole slide imaging, including redundant processes, transportation and delayed diagnosis, Histolix could significantly impact cost reduction, enable short term treatment and reduce personal trauma due to delayed diagnosis. We look forward to achieving these goals.”
The pathology market is immense with over 4.5M biopsies performed per year and over 1.2M surgeries accelerating at a six percent rate annually. The global cancer biopsy market is projected to reach $33B USD by 2027. 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 is 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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