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, and NeoGenomics, Inc. (Nasdaq:NEO), a leading
oncology testing services company, today announced a multi-year
exclusive strategic commercial collaboration that will advance
minimal residual disease (MRD) monitoring options for patients with
select blood cancers.
Adaptive’s next-generation sequencing (NGS)-based clonoSEQ® is
the first and only FDA-cleared in vitro diagnostic (IVD) test to
detect MRD in lymphoid cancers. NeoGenomics’ COMPASS® and
CHART® are a family of comprehensive and personalized
assessment services for complex blood cancers, offering a unique
multi-modal testing approach for every patient. With the growing
adoption of MRD testing, the integration of clonoSEQ with COMPASS
and CHART will help oncologists provide patients with personalized
treatment strategies using advanced methods for evaluating patient
risk status and delivering real-time insights into disease
progression.
“Our partnership with NeoGenomics reflects our shared commitment
to empowering oncologists and pathologists to deliver the highest
quality patient care,” said Chad Robins, chief executive officer
and co-founder of Adaptive Biotechnologies. “As a leader in
oncology testing with an extensive menu of precision oncology
offerings, NeoGenomics is a natural partner for us. We are proud of
this collaboration, which expands access to the valuable insights
that clonoSEQ MRD results offer, ultimately helping more providers
and patients benefit from knowing their MRD status.”
Under the terms of the exclusive agreement, COMPASS evaluations
performed for patients with multiple myeloma (MM), B-cell acute
lymphoblastic leukemia (B-ALL), chronic lymphocytic leukemia (CLL),
and diffuse large B-cell lymphoma (DLBCL) can now include a
clonoSEQ Clonality (ID) test, which identifies patient-specific DNA
sequences at initial diagnosis and enables that patient for
clonoSEQ MRD tracking. Subsequent CHART assessments performed for
those patients can then include clonoSEQ MRD testing throughout the
continuum of care. clonoSEQ testing will continue to be performed
by Adaptive Biotechnologies’ CLIA-certified, CAP-accredited
laboratory in Seattle.
Clinicians using NeoGenomics’ COMPASS to confirm a blood cancer
diagnosis can now simultaneously identify the DNA sequences
required to track their patient’s cancer, ensuring newly diagnosed
patients have access to clonoSEQ MRD insights throughout their
treatment. These patients also increase their likelihood of
qualifying for the growing number of clinical trials that rely on
clonoSEQ to guide or assess therapy. The ability for clinicians to
obtain ongoing MRD testing via CHART, will make longitudinal
monitoring of disease burden seamless and will enable clinicians
less familiar with MRD to leverage the results at the most
medically appropriate timepoints.
“MRD testing is widely recognized as an integral part of
blood cancer patient care, serving not only as a powerful
prognostic tool but also guiding
clinical decision-making,” said Chris Smith, chief executive
officer of NeoGenomics. “NeoGenomics is proud to offer our
customers access to clonoSEQ, the gold standard for clinical MRD
monitoring. We believe Adaptive is the market leader in heme MRD
and this strategic commercial collaboration reflects our broader
commitment to providing best-in-class, personalized diagnostic
testing for patients for their entire cancer journey while
strengthening our leadership position in hematology testing.”
Following today’s announcement, Adaptive and NeoGenomics will
begin implementing the commercial and operational infrastructure
needed to support the partnership. The companies expect to launch
cross-promotional efforts later this year. Specific financial terms
of the agreement are not disclosed.
About clonoSEQ clonoSEQ® is available as
an FDA-cleared in vitro diagnostic (IVD) test service provided by
Adaptive Biotechnologies to detect measurable 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).
Additionally, clonoSEQ is available for use in other lymphoid
cancers and specimen types as a CLIA-validated laboratory developed
test (LDT). To review the FDA-cleared uses of clonoSEQ,
visit clonoSEQ.com/technical-summary. clonoSEQ is CE-marked
under the In Vitro Diagnostic Regulation (IVDR) in the
European Union (EU). For the approved intended use in the EU under
IVDR, please refer to the instructions for use, available on
request.
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 treatment, inform
changes in therapy, monitor disease burden over time, and detect
potential relapse early. Clinical practice guidelines in
hematologic 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,
B-ALL and DLBCL.
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 segments:
Minimal Residual Disease (MRD) and Immune Medicine. Our commercial
products and clinical pipeline enable the diagnosis, monitoring,
and treatment of diseases such as cancer and autoimmune disorders.
Our goal is to develop and commercialize immune-driven clinical
products tailored to each individual patient.
About NeoGenomics, Inc.NeoGenomics, Inc. is a
premier cancer diagnostics company specializing in cancer genetics
testing and information services. We offer one of the most
comprehensive oncology-focused testing menus across the cancer
continuum, serving oncologists, pathologists, hospital systems,
academic centers, and pharmaceutical firms with innovative
diagnostic and predictive testing to help them diagnose and treat
cancer. Headquartered in Fort Myers, FL, NeoGenomics operates a
network of CAP-accredited and CLIA-certified laboratories for
full-service sample processing and analysis services throughout the
US and a CAP-accredited full-service sample-processing laboratory
in Cambridge, United Kingdom.
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
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actual results, levels of activity, performance or achievements to
be materially different from the information expressed or implied
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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 Investor Contact:Karina Calzadilla,
Vice President, Investor Relations and
FP&A201-396-1687investors@adaptivebiotech.com
Adaptive Media Contact:Erica Jones, Associate
Director, Corporate
Communications206-279-2423media@adaptivebiotech.com
NeoGenomics Investor Contact:Kendra Sweeney,
Vice President, Investor Relations, Communications, and
ESGkendra.sweeney@neogenomics.com
NeoGenomics Media Contact:Andrea
Sampsonasampson@sampsonprgroup.com
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