SpIntellx, CellNetix collaborate to validate HistoMapr-Breast
August 2020—SpIntellx and CellNetix Pathology & Laboratories will collaborate to validate the SpIntellx HistoMapr-Breast Platform. The platform is the first in the companies’ larger efforts to use explainable artificial intelligence-assisted lab processes in the development of diagnostics, prognostics, therapeutic strategies, and drug development for tumor and non-tumor diseases.
SpIntellx is a computational and systems pathology company that uses the computational power of unbiased spatial analytics and explainable AI technologies to offer proprietary software products and services for analyzing pathology tissue sections.
The advanced spatial analytics capture the architecture and communication patterns of the various histological structures, thus yielding maximally predictive information from patients’ tissue sections to inform therapeutic strategies and clinical decisions. HistoMapr-Breast uses this information to provide clear and unbiased justifications for its automated recommendations. As a result, the companies say, pathologists and other software users can ask “why?” and HistoMapr-Breast can answer this basic question, using data to explain its decisions. “This is a vital feature in building trust and transparency between pathology disease experts and computational pathology systems, and it is also a departure from more traditional black-box AI approaches to digital pathology such as deep learning,” SpIntellx and CellNetix said in a July 7 statement.
HistoMapr-Breast is the first of many planned spatial analytics and explainable AI pathologist guides designed to do the following: triage the case workload to direct the most difficult and borderline cases to subspecialists, perform retroactive quality assurance to improve pathologists’ accuracy and efficiency and reduce intra- and inter-pathologist discordance, provide transparent explainable AI guidance that explains why the algorithms made a specific recommendation, and facilitate standardized reporting in real time. The HistoMapr technology and approach is generalizable to a range of diseases, both tumor and non-tumor in nature.
SpIntellx co-founder and CEO S. Chakra Chennubhotla, PhD, says the validation of HistoMapr-Breast is the final step in the commercialization process.
FDA approves HPV test with extended genotyping capabilities
BD received approval for a pre-market approval supplement from the Food and Drug Administration for an expanded version of its BD Onclarity HPV Assay. The PMA supplement includes the expansion for genotype reporting beyond HPV genotypes 16, 18, and 45 to include genotypes 31, 51, 52, 33/58, 35/39/68, and 56/59/66.
The BD Onclarity HPV Assay has FDA approval for clinical use in cytology-based screening with ASC-US triage, in cotesting, and in primary HPV screening. It has FDA approval for use in vaccinated women.
CE-IVD launch for Roche uPath PD-L1 (SP263) image analysis
Roche announced on June 26 the CE-IVD launch of its automated digital pathology algorithm, the uPath PD-L1 (SP263) image analysis for non-small cell lung cancer. The algorithm provides pathologists with automated assessments of scanned slide images.
Validated on the Ventana PD-L1 (SP263) assay, the algorithm is ready-to-use and integrated within the Roche uPath enterprise software. Roche says it will help pathologists quickly determine whether tumors are positive for the PD-L1 biomarker.
Roche Diagnostics CEO Thomas Schinecker said in a statement that the uPath PD-L1 (SP263) image analysis for NSCLC is the first next-generation CE-IVD PD-L1 algorithm to the clinical market. It follows the 2019 release of the uPath enterprise software.
Invitae to combine with ArcherDX
Invitae and ArcherDX have entered into a definitive agreement under which Invitae will combine with ArcherDX to create a genetics leader in cancer genetics and precision oncology.
Integrating germline testing, tumor profiling, and liquid biopsy technologies and services in a single platform will enable precision approaches from diagnostic testing to therapy optimization and monitoring, expanding access to best-in-class personalized oncology, the companies said in a June 22 statement.
Broad adoption of precision oncology has been limited, they said, particularly in regional and community settings.
Latest on COVID-19
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