SEATTLE, Sept. 13, 2023 (GLOBE NEWSWIRE) -- Adaptive Biotechnologies Corporation (Nasdaq: ADPT), a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, today announced that clonoSEQ® is now available to health care providers as a fully integrated test in Aura, Epic’s specialty diagnostics suite. This integration will allow providers to order and review clonoSEQ minimal residual disease (MRD) testing results in Epic as they would for any test performed directly at the site of care.
MRD refers to the number of cancer cells that might remain in a patient’s body during and after treatment and that may eventually lead to recurrence of the disease. clonoSEQ is the only FDA-cleared test to detect MRD in bone marrow from patients with multiple myeloma or B-cell acute lymphoblastic leukemia (B-ALL) and blood or bone marrow from patients with chronic lymphocytic leukemia (CLL). clonoSEQ is also available for use in other lymphoid cancers and specimen types as a CLIA-validated laboratory-developed test (LDT). MRD is one of the strongest predictors of outcomes in blood cancers and routine testing provides a personalized way to track a patient’s individual response to treatment and inform clinical decision-making to optimize care.
“Partnering with Epic, a top EHR provider in the U.S., is an integral part of our vision for a best-in-class customer experience and will accelerate adoption of the test by removing workflow-related barriers that send-out tests commonly face,” said Susan Bobulsky, senior vice president, diagnostics, Adaptive Biotechnologies. “Based on positive feedback from our earliest adopters, and significant interest conveyed by other sites, we will advance our nationwide deployment efforts in order to provide a seamlessly integrated testing experience in Epic for as many providers and patients as possible.”
Under the partnership established in September 2022, clonoSEQ is available to healthcare providers through Aura, Epic's specialty diagnostics suite. Integration with Epic EHR provides convenient access to clonoSEQ MRD results along with discrete data directly in patient records, enabling faster, more efficient decision-making for oncologists and equipping patients with real-time insights into their disease status.
“A clear understanding of MRD status can provide valuable information throughout the care journey – for patients and physicians alike,” said Flora Stondell, FNP-C, nurse practitioner supervisor, division of malignant hematology/cellular therapy and transplantation, UC Davis Comprehensive Cancer Center. “Integrating clonoSEQ into UC Davis’ EHR system will reduce administrative time and further enable personalization of care based on MRD status and treatment response.”
“Collaboration between providers and diagnostics labs is critical to the advancement of personalized medicine,” said Alan Hutchison, vice president at Epic. “By making clonoSEQ available through Aura, Adaptive is helping providers incorporate discrete MRD test results into their clinical decision-making, which will have a significant impact on blood cancer patient care.”
Adaptive and Epic will continue to expand institutional access to clonoSEQ through Epic’s EHR on an ongoing basis. Practices that wish to access clonoSEQ MRD testing directly via Epic should contact their Adaptive account representative or Adaptive’s Account Operations team at clonoSEQAccountOps@adaptivebiotech.com.
clonoSEQ® is the first and only FDA-cleared in vitro diagnostic (IVD) test service to detect minimal residual disease (MRD) in bone marrow from patients with multiple myeloma (MM) or B-cell acute lymphoblastic leukemia (B-ALL) and blood or bone marrow from patients with chronic lymphocytic leukemia (CLL). clonoSEQ is also available for use in other lymphoid cancers and specimen types as a CLIA-validated laboratory-developed test (LDT). MRD refers to the small number of cancer cells that can stay in the body during and after treatment.
clonoSEQ leverages Adaptive Biotechnologies’ proprietary immune medicine platform to identify and quantify specific DNA sequences found in malignant cells, allowing clinicians to assess and monitor MRD during and after treatment. The assay provides standardized, accurate and sensitive measurement of MRD that allows physicians to predict patient outcomes, assess response to therapy over time, monitor patients during remission and predict potential relapse. Clinical practice guidelines in hematological malignancies recognize that MRD status is a reliable indicator of clinical outcomes and response to therapy, and clinical outcomes have been shown to be strongly associated with MRD levels measured by clonoSEQ in patients diagnosed with CLL, MM and ALL.
For important information about the FDA-cleared uses of clonoSEQ, including the full intended use, limitations, and detailed performance characteristics, please visit www.clonoSEQ.com/technical-summary.
Adaptive Biotechnologies is a commercial-stage biotechnology company focused on harnessing the inherent biology of the adaptive immune system to transform the diagnosis and treatment of disease. We believe the adaptive immune system is nature’s most finely tuned diagnostic and therapeutic for most diseases, but the inability to decode it has prevented the medical community from fully leveraging its capabilities. Our proprietary immune medicine platform reveals and translates the massive genetics of the adaptive immune system with scale, precision and speed to develop products in our Immune Medicine and Minimal Residual Disease (MRD) businesses. For more information, please visit adaptivebiotech.com and follow us on www.twitter.com/adaptivebiotech.
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Erica Jones, Associate Director, Corporate Communications
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