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.
About clonoSEQ 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.
About AdaptiveAdaptive 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.
Forward Looking StatementsThis 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.
MEDIA CONTACT:Erica Jones, Associate Director,
Corporate Communications206-279-2423media@adaptivebiotech.com
ADAPTIVE INVESTORS:Karina Calzadilla, Vice
President, Investor Relations201-396-1687
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