May 30, 2025

OncoHost Developing NeutroFlow Test for Guiding Cancer Therapy Selection

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OncoHost Developing NeutroFlow Test for Guiding Cancer Therapy Selection

May 30, 2025 | Justin Petrone

NEW YORK – OncoHost, an Israeli biotechnology company, is working with three European medical centers to produce a new flow cytometry test to predict patient response to immunotherapies for five cancer indications, according to Michal Harel, OncoHost's VP of translational medicine. The Binyamina-based company earlier this month announced the formation of the consortium to develop the test, called NeutroFlow, as well as its backing with a €2.5 million ($2.8 million) grant awarded through the EU's European Innovation Council Transition (EIT) program. The project officially commenced on May 1 and will run through April 2028.

Harel described NeutroFlow as a "novel project focused on the development and validation of a point-of-care diagnostic assay" that will predict a patient's response to immune checkpoint inhibitors (ICIs) across different cancer types. The cancer types targeted include non-small cell lung cancer, renal cell carcinoma, melanoma, head and neck squamous cell carcinoma, and triple-negative breast cancer.

Specifically, Harel said the test would measure the expression of a subset of neutrophils, called Ly6Ehi neutrophils, that are distinguished by a high expression of the Ly6E marker on the cell surface. She referred to a study published in Cancer Cell last year by researchers at Technion-Israel Institute of Technology and partners. In the paper, researchers demonstrated that this subset of Ly6Ehi neutrophils can serve as an "accurate predictor of response to immune checkpoint inhibitor therapy across multiple cancer types, outperforming conventional biomarkers," Harel said.

OncoHost's plan is to develop a flow cytometry test for measuring Ly6Ehi in patients and using those measurements, combined with its own computational pipeline, to predict how they would respond to different cancer therapies, ultimately leading to better cancer treatment selection.

"Ly6Ehi neutrophils can be easily detected and measured using flow cytometry, an instrument that is available in every hospital, utilized for other clinical tests," Harel pointed out. "The NeutroFlow test will be designed to provide a simple-to-use, rapid flow cytometry-based test for measuring Ly6Ehigh neutrophils in peripheral blood samples," she said.

Current plans are to have a test ready for implementation in hospitals by May 2027, Harel said, and a commercial version of the test will be deployed by 2028 via

OncoHost's US laboratory in Cary, North Carolina, as a laboratory-developed test. Harel said that OncoHost and its partners intend to pursue both US and European regulatory clearance for the resulting assay, which, with clinical trials, could take until 2031 to achieve. All business plans around the test, she added, will be finalized by the end of this year.

"The test is planned to be a point-of-care test running in the clinic," confirmed Harel. "We aim to obtain a CE-IVD certificate for that in Europe and Food and Drug Administration approval in the US."

Each partner in the NeutroFlow consortium will contribute "complementary expertise" to the effort, said Harel. OncoHost is the project coordinator, and it will manage the endeavor, providing its know-how in product development, computation modeling, and business development. The European Institute of Oncology, based in Milan, will provide access to its flow cytometry facility and will also contribute patient blood samples. IEO will also conduct on-site flow cytometry analyses and lead related assay development and analytical validation of the test, Harel said.

Heidelberg University Hospital in Germany will also provide blood samples and will perform flow cytometry analyses. Virgen Macarena University Hospital in Seville, Spain, is another partner that will provide blood samples and flow cytometry analyses. The same hospital will also lead the clinical study component of the project, Harel noted, "based on their vast experience in running large clinical trials." By including partners from Italy, Germany, and Spain, OncoHost will be able to validate its assay "across diverse European healthcare settings," remarked Harel.

Petros Christopoulos, a professor of medicine at Heidelberg University Hospital, said that as a partner in the project, he is looking forward to developing NeutroFlow as a cell-based immunotherapy test "for use in daily clinical practice for further personalization of our cancer patient care."

OncoHost was established in 2017 to commercialize the research of Yuval Shaked, who leads an academic research laboratory at Technion-Israel Institute of Technology in Haifa. Shaked, whose work has focused on understanding tumor-host interactions and the therapy-induced mechanisms of tumor progression, is a cofounder of OncoHost and serves as its chief scientific adviser.

OncoHost's CEO is Ofer Sharon, a "serial entrepreneur" in Harel's words, who has led the company since 2019. Sharon is also the cofounder and president of Valera Health, a mental healthcare services provider with offices in Tel Aviv and Brooklyn.

For OncoHost, NeutroFlow is an opportunity to expand its menu beyond its flagship ProphetNSCLC test, which the firm offers to support decisions concerning first-line

immunotherapies for the treatment of non-small cell lung cancer. That product has been available as a laboratory-developed test through OncoHost's facility in Cary.

In December, the company announced that its CLIA-certified North Carolina lab had received accreditation from the College of American Pathologists (CAP). Harel said ProphetNSCLC will be made available in Europe in 2027.

ProphetNSCLC's results are generated through interrogating a patient's blood sample using OncoHost's Prophet platform, which surveys 7,000 proteins using a Standard BioTools SomaScan panel. Harel noted that OncoHost has an agreement with South San Francisco, California-based Standard BioTools to use SomaScan as part of its configuration. In addition to running the proteomic assay, the company has at its disposal "advanced computational tools for analyzing high-dimensional proteomic profiles," said Harel, which enable "deeper insights into biological mechanisms of disease and treatment response."

While the company works on NeutroFlow and continues to commercialize ProphetNSCLC, it has two other assays in various stages of development. One of these is called ProphetRCC, focused on renal cell carcinoma, and the other is ProphetMelanoma. Harel described both tests as being "in advanced stage clinical trials," and said the tests rely on similar advanced machine-learning algorithms and proteomic profiling to predict patient response to ICIs.

The company has another assay in development called ProphetIRAE, which has been designed to support the management of immunotherapy safety through predicting severe immune-related adverse events or immune response adverse events.

"This test adds additional clinical insights to support decision-making, enabling oncologists to proactively mitigate risks, improving patient outcomes and treatment tolerability," commented Harel. Such a test will be integrated into OncoHost's menu by helping clinicians make better therapy decisions while minimizing associated toxicity.

The anticipated launch date for ProphetRCC will be the fourth quarter of this year, followed by an early 2026 launch for ProphetMelanoma. ProphetIRAE will also launch in Q4, Harel said. All will be available via the company's lab in North Carolina, with no specific launch date for Europe planned yet, she added.