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 a partnership with Epic to integrate
the clonoSEQ® Assay into Epic’s comprehensive electronic medical
record (EMR) system.
For patients with blood cancers like chronic lymphocytic
leukemia (CLL), multiple myeloma (MM), and B-cell acute
lymphoblastic leukemia (ALL), clonoSEQ is the only FDA-cleared test
that can monitor minimal residual disease (MRD), which refers to
the remaining number of cancer cells that might remain in a
patient’s body during and after treatment. These cancer cells often
exist in such small numbers that traditional testing methods can
fail to detect them, so routine MRD testing throughout a patient’s
cancer journey can help oncologists assess prognosis, determine
response to treatment, detect relapse, and inform care with more
precision. Integrating clonoSEQ with Epic will streamline clinical
decision-making for oncologists by providing easy access to
clonoSEQ testing and weaving results seamlessly into patient
records through the nation’s most widely used EMR
system.
“EMR integration is clearly the path forward to expanding access
and increasing ease of use for advanced oncology tests like
clonoSEQ,” said Nitin Sood, chief commercial officer, MRD, Adaptive
Biotechnologies. “MRD is most powerful when monitored serially over
time, and Epic integration will enable providers to efficiently
leverage clonoSEQ MRD results at multiple points in the patient
care continuum.”
Epic integration will enhance the clonoSEQ customer experience
by allowing providers to order and review clonoSEQ results from
Adaptive in the same way as they would any test performed directly
at the site of care. Integration will simplify MRD testing
workflows for cancer care providers who use Epic in institutions
and practices across the country. Adaptive’s work with Epic will
commence immediately, with clonoSEQ integration expected to go live
in 2023.
“The use of tests that can guide the course of cancer
treatment—and ultimately help save lives—shouldn’t be limited by
the walls that separate oncologists from the nation’s leading
diagnostic labs,” said Alan Hutchison, vice president at Epic.
“Together, Adaptive and Epic can help oncologists understand their
patients’ responses to treatment more precisely by spotting even a
single cancer cell hiding among millions of healthy cells.”
Adaptive is committed to efforts that will expand access to
clonoSEQ testing for patients across the U.S. Building on its
flagship integration partnership with Epic, Adaptive will continue
to pursue integration opportunities with other oncology EMR
vendors, particularly those with leading positions in community
oncology. The company will also continue to enable clonoSEQ
ordering and reporting through its secure online portal and via its
partnership with Labcorp, ensuring that oncology care providers can
order tests and access results in a way that best suits the needs
of their practice and their patients.
About the clonoSEQ Assay The clonoSEQ
Assay 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). It is also
clonoSEQ testing for diffuse large B-cell lymphoma (DLBCL) patients
is currently available for clinical use as a laboratory-developed
test (LDT) performed at Adaptive's CLIA-certified lab in Seattle,
WA. clonoSEQ ctDNA-based MRD testing in DLBCL has also been
approved by New York State's Clinical Laboratory Evaluation Program
(CLEP). Medicare covers clonoSEQ in these four indications and is
aligned with clinical practice guidelines which support assessing
MRD at multiple time points throughout therapy to monitor treatment
response and help predict patient outcomes.
The clonoSEQ Assay 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 the clonoSEQ Assay in patients diagnosed
with CLL, MM, ALL and DLBCL.
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.
About Adaptive BiotechnologiesAdaptive
Biotechnologies (“we” or “our”) 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. We apply our platform to partner
with biopharmaceutical companies, inform drug development, and
develop clinical diagnostics across our two business areas: Minimal
Residual Disease (MRD) and Immune Medicine. Our commercial products
and clinical pipeline enable the diagnosis, monitoring, and
treatment of diseases such as cancer, autoimmune disorders, and
infectious diseases. Our goal is to develop and commercialize
immune-driven clinical products tailored to each individual
patient.
Forward-Looking Statements This press
release contains forward-looking statements that are based on
management’s beliefs and assumptions and on information currently
available to management. All statements contained in this release
other than statements of historical fact are forward-looking
statements, including statements regarding our ability to develop,
commercialize and achieve market acceptance of our current and
planned products and services, our research and development efforts
and other matters regarding our business strategies, use of
capital, results of operations and financial position and plans and
objectives for future operations.
In some cases, you can identify forward-looking statements by
the words “may,” “will,” “could,” “would,” “should,” “expect,”
“intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,”
“project,” “potential,” “continue,” “ongoing” or the negative of
these terms or other comparable terminology, although not all
forward-looking statements contain these words. These statements
involve risks, uncertainties and other factors that may cause
actual results, levels of activity, performance or achievements to
be materially different from the information expressed or implied
by these forward-looking statements. These risks, uncertainties and
other factors are described under "Risk Factors," "Management's
Discussion and Analysis of Financial Condition and Results of
Operations" and elsewhere in the documents we file with the
Securities and Exchange Commission from time to time. We caution
you that forward-looking statements are based on a combination of
facts and factors currently known by us and our projections of the
future, about which we cannot be certain. As a result, the
forward-looking statements may not prove to be accurate. The
forward-looking statements in this press release represent our
views as of the date hereof. We undertake no obligation to update
any forward-looking statements for any reason, except as required
by law.
ADAPTIVE MEDIA Laura Cooper, Sr. Director,
Corporate Communications
205-908-5603 media@adaptivebiotech.com
ADAPTIVE INVESTORS Karina Calzadilla, Vice
President, Investor Relations 201-396-1687
Carrie Mendivil, Gilmartin
Group investors@adaptivebiotech.com
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