Adaptive Biotechnologies Receives New York State CLEP Approval for clonoSEQ to Detect and Monitor Minimal Residual Disease (M...
July 31 2019 - 4:15PM
Adaptive Biotechnologies Corporation (Nasdaq:ADPT) (“Adaptive”), a
commercial-stage biotechnology company that reads and translates
the genetic code of the adaptive immune system with the goal of
developing personalized diagnostics and therapeutics to improve
patient lives, today announced that the State of New York Clinical
Laboratory Evaluation Program (CLEP) has approved the clonoSEQ®
Assay for the detection and monitoring of minimal residual disease
(MRD) in patients with B-cell blood cancers. In addition to CLEP
approval, clonoSEQ is also the first test to be authorized by the
U.S. Food and Drug Administration (FDA) for MRD assessment in bone
marrow samples from patients with B-cell acute lymphoblastic
leukemia (ALL) and multiple myeloma.
The CLEP approval makes clonoSEQ testing
accessible to patients in New York who have been diagnosed with
B-cell cancers, a subset of lymphoid cancers that includes ALL,
multiple myeloma, chronic lymphocytic leukemia (CLL) and B-cell
non-Hodgkin’s lymphoma (NHL). Testing under CLEP may be performed
using DNA from bone marrow, blood and archived tissue samples. With
this approval, clonoSEQ MRD testing is now available in all 50
states and has a considerable and growing payor footprint
(>140MM covered lives to date).
“New York State CLEP approval for clonoSEQ means patients in New
York can now work with their cancer care team to incorporate
clonoSEQ into their treatment regimen to accurately and reliably
assess and monitor their disease over time, using multiple sample
types, including blood samples,” said, Chad Robins, CEO and
co-founder, Adaptive Biotechnologies. “This rigorous approval
also supports our ongoing work to expand access to patients and our
pursuit of FDA authorization for new indications for clonoSEQ in
other lymphoid cancers and sample types.”
clonoSEQ has been ordered by clinicians in nearly 300 healthcare
systems and institutions, including 27 of the 28 NCCN centers in
the United States, and used by more than 30 biopharmaceutical
companies in over 120 clinical trials.
“The approval gives patients in New York access to the
standardized, FDA-cleared clinical MRD testing that is already
being utilized throughout the rest of the country,” said Dr. Ajai
Chari, Associate Professor of Medicine, Hematology and Medical
Oncology at The Tisch Cancer Institute at Mount Sinai, who was a
past consultant for the clonoSEQ Assay.
About the
clonoSEQ AssayThe 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 biotech 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.
Caution Regarding Forward-Looking
StatementsThis press release may contain forward-looking
statements regarding Adaptive’s current expectations, including its
ability to read and translate the genetic code of the adaptive
immune system to develop personalized diagnostics and therapeutics
to improve patient lives. Words such as “may,” “believe,”
“expect,” “estimate,” “predict,” or similar expressions, or
statements regarding intent, belief, or current expectations are
forward-looking statements.
These statements are not guarantees of future performance and
are subject to certain risks, uncertainties and assumptions that
are difficult to predict. Factors that could cause actual results
to differ include, but are not limited to, those described more
fully in the section captioned “Risk Factors” in the final
prospectus related to the public offering filed with the Securities
and Exchange Commission. Forward-looking statements contained in
this announcement are made as of this date, and Adaptive
Biotechnologies undertakes no duty to update such information
except as required under applicable 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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