Savicell Diagnostics Ltd. has reported high accuracy results from a study validating its liquid biopsy platform Immunobiopsy. Haifa, Israel-based Savicell said the platform achieved high accuracy identifying lung cancer across stages I to IV. In a cohort of 245 participants, the Immunobiopsy test achieved 97% sensitivity and 97% specificity among patients with lung cancer.
Onkos Surgical Inc. nabbed an additional $15 million from its existing investors in a series C fundraising round. The Parsippany, N.J.-based company plans to use the new cash to accelerate research and development for its product line which is designed to meet the specialized needs of oncology patients who require orthopedic surgery and the surgeons who work with them.
LONDON – Ibex Medical Analytics Ltd. has secured a second CE marking for its Galen artificial intelligence decision support system for automated interpretation of tumor biopsies, adding breast cancer to the approval in prostate cancer secured just over a year ago. The CE mark follows results from a blinded, multicenter clinical study at Institut Curie in France and Maccabi Healthcare Services in Israel. Ibex says that in the trial Galen breast demonstrated very high accuracy in detecting various types of breast cancer.
TORONTO – Perimeter Medical Imaging Inc. has been awarded an FDA breakthrough device designation for a machine learning medical platform it said drives ultra-high-resolution, real-time imaging of breast cancer. Data collected from multiple pathology labs in Texas this past year were fed through the optical coherence tomography (OCT) imaging system which now is at the stage where its Imgassist artificial intelligence (AI)-based algorithms can be tested.
The U.S. Centers for Medicare and Medicaid Services (CMS) has significantly relaxed the national restrictions on coverage of next-generation sequencing for cancer, affirming that early-stage breast and ovarian cancer patients will be covered. However, Medicare administrative contractors can cover tests that have not been reviewed by the FDA, a move that should also significantly boost utilization for makers of next-generation sequencing systems in clinical labs.
LONDON – Advanced Oncotherapy plc is starting verification and validation of the world’s first linear proton beam accelerator system, which is assembled and ready for testing at the Daresbury particle physics laboratory in Cheshire, U.K.
HONG KONG – Lucence Diagnostics Pte Ltd., a genomic medicine company headquartered in Singapore, has secured $20 million in series A investment. The company is focused on inventing liquid biopsy tests for cancer screening and personalizing care.
There are a pair of approved CAR T drugs, Yescarta (axicabtagene ciloleucel) from Gilead Sciences Inc. and Kymriah (tisagenlecleucel) from Novartis AG, that have been available since 2017 for a few hematological cancers including some lymphomas and leukemias. But little is known about how these engineered chimeric antigen receptor T cells that both target CD19, an antigen prevalent in the cells of many B-cell malignancies, move through the body and proliferate after they are first removed, altered, expanded in number and, finally, returned to a patient's body.
LONDON – Pfizer Inc. is taking further steps to distinguish its third-generation anaplastic lymphoma kinase (ALK) inhibitor, Lorbrena, from the rest of the field, funding a pan-European trial that will use liquid biopsies to track the resistance profile of non-small-cell lung cancers (NSCLC).