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FDA clears SeptiCyte Rapid

January 2022—The Food and Drug Administration granted 510(k) clearance for SeptiCyte Rapid, which runs on Biocartis’ molecular diagnostics Idylla platform. It’s a fully automated, rapid host-response test that distinguishes sepsis from infection-negative systemic inflammation in patients suspected of sepsis.

FDA clearance was based on data from retrospective and prospective studies validating the clinical accuracy of SeptiCyte Rapid. The retrospective clinical study consisted of eight sites in the United States and Europe from the MARS clinical trial (NCT01905033) and VENUS clinical trial (NCT02127502). The prospective study, NEPTUNE, evaluated real-time performance of the test in a clinical setting at Emory University, Rush University, and the University of Southern California. In retrospective and prospective studies, the sepsis status of patients was determined by a three-member panel of expert physicians.

Immunexpress of Seattle will commercialize the test to ensure availability across the U.S. this year.

Roche releases newest AI-based digital pathology algorithms

Roche announced on Dec. 7 its research-use-only launch of three new automated digital pathology algorithms: uPath Ki-67 (30-9), uPath ER (SP1), and uPath PR (1E2) image analysis for breast cancer.

The algorithms are ready-to-use, Roche says, and integrated within its uPath enterprise software and Navify Digital Pathology, the cloud version of uPath.

Olympus announces 1st results of AI-based tool for gastric cancer

The results of Olympus’ ongoing joint research program to create an AI-based pathology diagnostic tool were announced at the Japan Society of Digital Pathology Study annual meeting in November 2021. The diagnostic tool achieved 100 percent sensitivity and 50 percent or more specificity for all gastric biopsy pathology specimens analyzed, according to an Olympus press release.

Olympus, through its Office of Innovation, began a collaboration with the Kure Medical Center and Chugoku Cancer Center in Japan in 2017 to develop an AI-based pathology diagnostic tool. In the initial testing phase, the AI was trained using 368 gastric biopsy pathology slide images.