New York, November 9th, 2021 — Rarecells, Inc., a healthcare company in the field of liquid biopsy, focused on the development and commercialization of non-invasive tests for early cancer detection, announced today that it has entered into an agreement with Columbia University to fund a clinical study evaluating its ISET® -AML test for early detection of acute myeloid leukemia (AML) in patients with myelodysplastic syndrome (MDS).
The study, expected to begin in Q1 2022, will be the first clinical evaluation of the ISET® -AML test. Azra Raza, M.D., Professor of Medicine at Columbia University Vagelos College of Physicians and Surgeons and Director of the MDS Center at Columbia University’s Herbert Irving Comprehensive Cancer Center, is the study’s principal investigator.
This clinical study aims to assess the clinical performance of the ISET® -AML test in the context of early AML detection.
Myelodysplastic syndromes are a group of diverse bone marrow disorders in which the bone marrow does not produce enough healthy blood cells. For roughly 30% of the patients diagnosed with MDS, this type of bone marrow failure syndrome will progress to AML, which is often fatal. Currently, patients with MDS are monitored with blood tests to measure complete blood cell counts and bone marrow analyses to detect the appearance of leukemic blasts heralding the development of AML. However, blood tests have a very low sensitivity to detect rare blasts and bone marrow tests involve an invasive procedure that cannot be repeated frequently. As a result, AML is often diagnosed when it is already well established and may be resistant to available treatment options.
The ISET® patented EC-marked platform is able to extract down to one single cancer cell of any type from 10 ml of blood, thus a tumor cell mixed with 100 million leukocytes and 50 billion erythrocytes, according to peer-reviewed published studies. The ISET® -AML test uses the ISET® platform to extract from blood the rare leukemic blast cells with unsurpassed sensitivity and detect them through suitable markers labelling, image analysis and AI.
Dr. Raza, who wrote the best-selling book “The First Cell and the Human Costs of Pursuing Cancer to the Last,” said: “New non-invasive tests are needed to detect the first leukemic cells in the blood of MDS patients so that we can identify and treat patients at risk of developing AML before the disease becomes established.”
Patrizia Paterlini, President and Chief Executive Officer of Rarecells, said: “We are pleased to be working with Columbia University’s Herbert Irving Comprehensive Cancer Center to conduct the first clinical evaluation of the ISET® -AML test in patients with MDS. The strategic decision to transition the ISET® -AML test to an investigator-sponsored study at Columbia will provide access to world-class expertise and has the potential to accelerate patients’ recruitment in order to expedite our clinical study. We look forward to a continued progress across our ISET® Early Cancer Detection program, which also includes ongoing studies in patients at risk of Prostate Cancer”.
Rarecells, Inc. is a healthcare company focused on the development and commercialization of non-invasive Early Cancer Detection tests. These tests are based on the ISET® platform technology that is able to extract from blood cancer cells from any type of cancer. Cancer cells extracted by ISET® are then diagnostically identified through immune-morpho molecular analyses combined with image analyses and AI. This approach is believed to be a significant advancement in the highly sensitive non-invasive detection of cancer’s signals providing a powerful tool for early cancer detection through the identification of the first circulating cancer cells.
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