Adaptive Biotechnologies Enters Partnership with Illumina to Develop Distributable IVD Test Kits for clonoSEQ and immunoSEQ D...
September 24 2019 - 7:00AM
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 Illumina, Inc.
(Nasdaq: ILMN) to develop in-vitro diagnostic (IVD) test kits for
Adaptive’s current and future portfolio of next-generation
sequencing (NGS)-based immunodiagnostics.
The test kits under development would expand the availability of
Adaptive’s clonoSEQ® Assay for assessing and monitoring minimal
residual disease (MRD) for the management of patients with certain
blood cancers and immunoSEQ Dx™ Assay for pipeline applications.
Clinicians currently order clonoSEQ to monitor MRD as a test
performed at Adaptive’s lab in Seattle. The planned IVD test
kits will make it possible for hospitals and health systems to run
Adaptive’s clonoSEQ and immunoSEQ Dx assays in their local
laboratories across the United States.
“We are proud to partner with Illumina to deliver on our promise
to develop distributable kits for our novel immunodiagnostics to
reach more patients,” said Chad Robins, chief executive officer and
co-founder of Adaptive Biotechnologies. “These IVD test kits will
further validate Adaptive as a valued partner for standardized MRD
monitoring and immune profiling solutions from research to the
clinic.”
Adaptive’s immune medicine platform is uniquely suited for the
development of standardized IVD test kits. Under the non-exclusive
agreement, Adaptive will develop the clonoSEQ and immunoSEQ Dx IVD
test kits to run on Illumina’s NextSeq™ 550Dx system. Adaptive will
be responsible for obtaining necessary regulatory approvals for
each IVD test kit and for their subsequent commercialization.
“By making Adaptive’s clonoSEQ more accessible to patients, we
are ensuring health care providers have access to a valuable part
of a growing genomics ecosystem. Partnerships that bring
exceptional clinical content to customers and patients represent an
exciting opportunity in clinical genomics,” said Dr. Phil Febbo,
Chief Medical Officer of Illumina. “We are committed to unlocking
the power of the genome through our work with Adaptive which will
expand access to genomic-based testing in order to improve patient
outcomes.”
About the
clonoSEQ Assay
The clonoSEQ Assay was granted de novo designation and marketing
authorization by FDA for the detection and monitoring of minimal
residual disease (MRD) in patients with multiple myeloma (MM) and
B-cell acute lymphoblastic leukemia (ALL) using DNA from bone
marrow samples. clonoSEQ is the first and only FDA-authorized in
vitro diagnostic assay for MRD testing. It is also the first
clinical diagnostic powered by immunosequencing to receive FDA
clearance. clonoSEQ leverages Adaptive’s proprietary
immunosequencing 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 detect 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 are
strongly associated with MRD levels measured by the clonoSEQ Assay
in patients diagnosed with ALL and MM. clonoSEQ testing is
covered by Medicare and an expanding list of private payors in
alignment with the FDA label.
clonoSEQ is a single-site assay performed at Adaptive
Biotechnologies. It is also available as a CLIA-regulated
laboratory developed test (LDT) service for use in other lymphoid
cancers. 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 Biotechnologies
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 life sciences research, clinical diagnostics, and drug
discovery. We have two commercial products, and a robust clinical
pipeline to diagnose, monitor and enable the treatment of diseases
such as cancer, autoimmune conditions and infectious diseases. Our
goal is to develop and commercialize immune-driven clinical
products tailored to each individual patient. For more information,
please visit
adaptivebiotech.com.
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 Adaptive
Biotechnologies’ partnership with Illumina, 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,”
“expect,” “plan,” “believe,” “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 the Company files with
the Securities and Exchange Commission (the "SEC") 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:Beth KeshishianDirector,
Corporate Communications 917-912-7195media@adaptivebiotech.com
INVESTOR CONTACT:Lynn Lewis or Carrie
Mendivil415-937-5405investors@adaptivebiotech.com
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