Diagnosing leukemia can be a straightforward matter that requires little more than analysis of a complete blood count. Too many white blood cells or too few red blood cells could herald leukemia. Flow cytometry may reveal the specific types of blood cell running amok—or not. Sometimes, leukemia stays in the bone marrow, making identification of the specific type more difficult. In those cases, a patient faces a more complex process that typically requires a bone marrow biopsy.
Reflexion Medical Inc. has been granted U.S. FDA marketing clearance for biology-guided radiotherapy to treat early and late-stage cancers. An expansion of the company’s existing X1 platform, Scintix is indicated for patients with lung and bone tumors which may arise from primary cancers or from metastatic lesions spread from other cancers in the body.
Dxcover Ltd. raised $9.25 million (£7.5 million) in a series A fundraising round and received a grant of $2.7 million (£2.2 million) from the European Innovation Council to support development of the company’s liquid biopsy platform for the detection of multiple early-stage cancers. Existing investors Eos Advisory LLP, Mercia Asset Management plc, Scottish Enterprise, University of Strathclyde, SIS Ventures and Norcliffe Capital led the round, which was also joined by Mark Banforth of Thairm Bio.
It’s the season for reevaluation as companies weed out programs that don’t offer much promise. At the head of the line is Sanofi SA’s once-potential myasthenia gravis blockbuster tolebrutinib. A partial clinical hold on the phase III study is part of the reasoning for stopping its development. But so is competition, the company said. Other companies eliminating development programs include Roche Holding AG, Gilead Sciences Inc., AB Science SA and Merck & Co. Inc.
New York-based Paige.AI Inc., was successful in its de novo application to the U.S. FDA for the company’s digital pathology software for identification of cancerous prostate tissue, but the agency needed nearly a year and a half after the September 2021 grant of de novo petition to post the regulation for this novel algorithm.
Precisedx Inc.’s digital artificial intelligence (AI) platform better predicts the recurrence of early-stage breast cancer within six years than traditional testing, a study published in Breast Cancer Research found. Understanding which patients with early-stage disease face significant risk of their cancer returning is important for guiding selection of treatment. The system reduces the variability inherent in histological characterization and grading of breast cancer (BC) today, thereby improving prognostic accuracy.
Oncohost Ltd., Baylor Scott & White Research Institute and the Translational Genomics Research Institute (TGen) have joined forces in a five-year study to improve personalized cancer therapy by better understanding resistance mechanisms. The team will analyze host response, patient microbiome, tumor DNA and immune system activity of 350 patients with non-small cell lung cancer (NSCLC).
Given the advances being made in cancer treatments, it’s time to move beyond the maximum tolerated dose (MTD) to dose-optimization trials for targeted therapies, the U.S. FDA said in a new draft guidance.
Two companies who needed partners have found each other, as privately held Elicio Therapeutics Inc. will merge with Angion Biomedica Corp. in an all-stock deal.
Act Genomics (Hong Kong) Ltd. won U.S. FDA approval for its genomic profiling test for solid tumors, Actonco. This marks the first time an Asia-based company has received FDA clearance for a comprehensive genomic profiling test.
