Adaptive Biotechnologies Receives Expanded Medicare Coverage of clonoSEQ® for Monitoring Minimal Residual Disease in Diffuse Large B-Cell Lymphoma
28 July 2022 - 9:30PM
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 Palmetto GBA, a Medicare
Administrative Contractor (MAC) that assesses diagnostic
technologies through its MolDX program, has expanded coverage
of the clonoSEQ® Assay to include monitoring minimal residual
disease (MRD) in Medicare patients with diffuse large
B-cell lymphoma (DLBCL), the most common type of non-Hodgkin
lymphoma (NHL). This coverage determination is the first for
clonoSEQ to include the assessment of MRD based on circulating
tumor DNA (ctDNA), fragments of DNA released into the blood from
lysed cancer cells.
MRD refers to the remaining number of cancer cells that may be
present in a patient’s body during and after treatment and that may
eventually lead to recurrence of the disease. MRD testing is a
simple blood test performed at multiple timepoints throughout a
patient’s cancer journey to assess prognosis, determine response to
treatment, detect relapse, and inform care. MRD assessment in DLBCL
utilizes ctDNA measured in peripheral blood to give oncologists a
better understanding of which patients are at high-risk for
recurrence and provide them with information to create a more
precise treatment plan for each patient.
“We’ve advanced therapy for large B-cell lymphomas significantly
in recent years; however, a considerable unmet need for highly
specific, precise monitoring of disease progression during and
after treatment remains,” said Frederick Locke, M.D., chair,
Department of Blood and Marrow Transplant and Cellular
Immunotherapy, Moffitt Cancer Center. “Measurement of ctDNA to
assess MRD provides additional information that can complement or
improve upon insights from imaging and that can help inform
clinical management.”
The updated coverage policy expands DLBCL patient access to
clonoSEQ MRD testing, as approximately 75% of actively treated
DLBCL patients are Medicare aged. The policy is effective
immediately and extends to all DLBCL patients, regardless of line
of therapy, treatment regimen, or testing timepoint. clonoSEQ
testing for 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).
“We believe clonoSEQ raises the bar for disease monitoring in
DLBCL patients. Recent studies have shown that MRD assessment with
clonoSEQ early post CAR-T treatment can be more informative than
PET-CT in identifying patients who were at high risk for relapse,”
said Nitin Sood, chief commercial officer, MRD, Adaptive
Biotechnologies. “The Medicare coverage decision provides greater
access to clonoSEQ and acknowledges the mounting evidence for
implementing routine clonoSEQ MRD assessment in DLBCL.”
This coverage expansion adds to
existing Medicare coverage for clonoSEQ in multiple
myeloma, chronic lymphocytic leukemia (CLL) and B-cell acute
lymphoblastic leukemia (ALL). Medicare coverage for clonoSEQ
in these indications 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.
About the clonoSEQ AssayThe 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). MRD refers to the
small number of cancer cells that can stay in the body during and
after treatment.
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 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. We have three commercial
products and a robust clinical pipeline to diagnose, monitor and
enable the treatment of diseases such as cancer, autoimmune
conditions and infectious diseases. For more information, please
visit adaptivebiotech.com and follow us
on www.twitter.com/adaptivebiotech.
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MEDIA CONTACT:Laura
Cooper206-693-2042media@adaptivebiotech.com
ADAPTIVE INVESTORS:Karina
Calzadilla201-396-1687
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