Roswell Park Licenses Rapid, Comprehensive Blood Test to Agilent, a Global Leader in the Life Sciences Market

BUFFALO, N.Y. — An advanced, high-speed blood cancer test developed at Roswell Park Comprehensive Cancer Center has been licensed for commercial development by Agilent Technologies Inc., a global leader in life sciences, diagnostics and applied markets. PanHeme, an assay used to support the clinical care of patients with blood cancers, including leukemias, lymphomas and myeloma, is a next-generation-sequencing (NGS) technology that can identify mutations in hundreds of genes in under 72 hours — a dramatic improvement over the three- to four-week wait time for the current leading NGS molecular test.

PanHeme enables physicians to diagnose hematological malignancies with greater precision and rapidly deploy therapies most likely to benefit a patient with a specific gene mutation. The diagnostic panel’s broader scope sets it apart from existing assays for blood cancers, which focus exclusively on single cancer types. The licensing agreement allows Agilent to commercialize the assay worldwide, with Roswell Park assisting in its development. The PanHeme panel will be a powerful tool combining Roswell Park’s PanHeme content, supported by Agilent’s SureSelect XT HS2 library preparation and target enrichment chemistry, Magnis NGS Prep system, Bravo automation platform, and Alissa secondary analysis software.*

Sean Glenn, PhD, left, and Carl Morrison, MD, DVM, the Roswell Park experts who led development of a unique rapid molecular diagnostic panel for hematologic cancers like leukemia, lymphoma and multiple myeloma.

“There are no comprehensive tests currently available commercially for precision analysis of myeloma and lymphoma. This will be the first,” says Carl Morrison, MD, DVM, Senior Vice President of Scientific Development and Integrative Medicine and Chair of the Department of Pathology & Laboratory Medicine at Roswell Park. “It’s a way to get the most effective and appropriate treatment to patients as quickly as possible, with tremendous potential benefit for both clinical outcomes and patients’ quality of life.”

“We’re excited by this opportunity with Roswell Park,” adds Ronda Allen, VP/GM of Agilent’s Genomics Division. “The PanHeme panel at clinical and translational researchers’ fingertips enables samples to be run immediately and accurately, speeding up the time to results, and ultimately patient treatment.”

Dr. Morrison developed, created and activated the PanHeme assay with Sean Glenn, PhD, Roswell Park’s Vice Chair of Molecular Pathology and Clinical Director of the cancer center’s Genomics Shared Resource.

“Our PanHeme panel covers every hematological malignancy and every mutation required to diagnose, treat and prognose these patients, and we can do it very quickly,” says Dr. Glenn. “The test screens the patient’s DNA and RNA for single-nucleotide variants, insertions, deletions, gene fusions and copy-number variations at the gene and chromosome levels critical for understanding and treating hematological cancers.”

The pair worked closely with Roswell Park experts in hematologic oncology, pathology, cytogenetics, flow cytometry, and hematopathology — including Manuel Glynias and clinicians Eunice Wang, MD, Chief of Leukemia, and James Thompson, MD, MS — to develop a comprehensive panel that could immediately benefit patients with hematologic malignancies.

“We have filled a huge void in hematological testing, and expect that this test will soon be used to guide treatment decisions for several thousands of cancer patients each year,” notes Patrick Emmerling, PhD, MBA, CLP, Director of Technology Transfer and Commercial Development at Roswell Park.

PanHeme is the latest in a long line of Roswell Park innovations to be licensed for further development. Among other innovations, the cancer center developed the prostate-specific antigen (PSA) test, now used worldwide for early detection of prostate cancer; the RPMI 1640 medium, used worldwide for cell culture; photodynamic therapy (PDT), an FDA-approved treatment that activates light-sensitive drugs with lasers; and, most recently, the therapeutic SurVaxM vaccine for glioblastoma, featured on NBC News in June and recently awarded Fast Track Designation by the U.S. FDA.

Over the past 18 months, Roswell Park’s hematologic oncologists have used PanHeme to support the clinical care of more than 1,400 unique patients with blood cancers. Currently, the service operates seven days a week to deliver results for 50-60 blood samples per week.

Jens Hillengass, MD, PhD, Chief of Myeloma at Roswell Park, says pinpointing gene mutations is especially important for guiding treatment decisions for patients with multiple myeloma and Waldenstrom’s macroglobulinemia (WM), a rare cancer of the white blood cells.

“Sometimes we can use medications that might be FDA-approved for other diseases, but that attack the same mutations that can occur in myeloma — and those medications might work better than standard myeloma treatments,” he explains.

Dr. Thompson says the biggest clinical change for his patients involves the speedy return of test results for TP-53, a mutation present in acute myeloid leukemia (AML), myelodysplastic syndromes (MDS), and myeloproliferative neoplasms (MPNs). “Unfortunately, patients with that mutation are much less likely to respond to therapy,” he explains. “The information provided by PanHeme allows us to offer some clinical trials that are specifically designed for those patients.

“This approach wouldn’t be feasible if we didn’t have the test. In the past, we’d get the results about three weeks after we sent the sample, and we’d find out about the TP-53 mutation after we had already committed patients to a run of therapy that might not be effective for them.”

Dr. Thompson adds that the assay will benefit the 30% of patients with AML who have an FLT3 mutation — an indicator of aggressive disease. “It definitely changes the type of therapy we prescribe, and it’s clinically important to have that result in a timely manner,” he says.

Every year in the U.S., nearly 60,000 patients are diagnosed with leukemia, 90,000+ with lymphoma, and 35,000+ with myeloma. Says Dr. Thompson, “PanHeme is a step toward much better patient-specific therapeutics. Having this available will improve the tool kit that everybody has to treat these diseases.”

Adds Dr. Morrison, “This is the best you can do for patients around the globe.”

Drs. Morrison and Glenn gratefully acknowledge the importance of donor support through the Roswell Park Alliance Foundation at critical early stages of this work.

Headquartered in Santa Clara, California, Agilent Technologies is a leading life science and Dx company delivering insights and innovation that help our customers bring great science to life. The company generated revenue of $6.85 billion in fiscal 2022 and employs 18,000 people worldwide. Information about Agilent is available at www.agilent.com.

*Agilent SureSelect, Magnis NGS Prep system, Bravo automation platform, and Alissa are for Research Use Only. Not for use in diagnostic procedures

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