Adaptive Biotechnologies Receives Updated Medicare Coverage for its Minimal Residual Disease (MRD) Assay, clonoSEQ® for Blood Cancer Patients
November 11 2021 - 4:52PM
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, announced that Palmetto GBA’s Molecular Diagnostics
Program (MolDX) has finalized a local coverage determination (LCD)
which supports the Medicare coverage for clonoSEQ® to detect and
monitor minimal residual disease (MRD) in patients with B-cell
acute lymphoblastic leukemia (ALL), multiple myeloma (MM) and
chronic lymphocytic leukemia (CLL).
“We are pleased that MolDX finalized the LCD for next-generation
sequencing (NGS) tests for MRD, solidifying patient access to the
critical results that our clonoSEQ Assay provides across the
continuum of care,” said Lance Baldo, MD, Chief Medical Officer of
Adaptive Biotechnologies. “This LCD provides a pathway for the
continued expansion of clonoSEQ into routine clinical care to
benefit the more than 700,000 patients living with lymphoid
malignancies in the United States.1 We look forward to our
continued work with Medicare to help evolve coverage within this
rapidly advancing field.”
The final LCD is consistent with the draft posted by Medicare in
September of 2020, which established coverage of MRD as a “series
of assays” in a patient with cancer and outlined specific coverage
criteria for MRD tests. The LCD states that MRD testing for cancer
is a sensitive and specific way to measure relative amounts of
cancer cells in the body and has demonstrated its ability to impact
patient care. The LCD also mentions that MRD assessment with
clonoSEQ in lymphoid cancers, including ALL, MM and CLL, is a
well-established tool for physicians.
clonoSEQ is the first and only U.S. Food and Drug Administration
(FDA)-cleared assay for MRD assessment in CLL, MM and ALL, and is
widely available to clinicians and patients across the U.S.
clonoSEQ leverages the power of NGS and offers an accurate and
reliable way to assess how disease burden changes over time in
response to treatment or during remission. When utilized as a
series of tests throughout a patient’s journey with cancer, the
assay can help clinicians predict long-term outcomes, assess
treatment response, monitor disease burden and detect potential
relapse. clonoSEQ has broad coverage in the U.S., with over 240
million covered lives across both Medicare and commercial
payers.
About the clonoSEQ AssayThe clonoSEQ Assay is
the first and only FDA-cleared assay for MRD in chronic lymphocytic
leukemia (CLL), multiple myeloma (MM) and B-cell acute
lymphoblastic leukemia (ALL). Minimal residual disease (MRD) refers
to the small number of cancer cells that can stay in the body
during and after treatment. clonoSEQ was initially granted De Novo
designation and marketing authorization by the FDA for the
detection and monitoring of MRD in patients with MM and ALL using
DNA from bone marrow samples. In August 2020, clonoSEQ received
additional clearance from the FDA to detect and monitor MRD in
blood or bone marrow from patients with CLL.
The clonoSEQ Assay leverages Adaptive’s 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.
The clonoSEQ Assay is a single-site test performed at Adaptive
Biotechnologies. In addition to its FDA-cleared uses, clonoSEQ is
also available as a CLIA-validated laboratory developed test (LDT)
service for use in other lymphoid cancers and sample types. 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 BiotechnologiesAdaptive
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
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. Our goal is
to develop and commercialize immune-driven clinical products
tailored to each individual patient. 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
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References
- National Cancer Institute. Cancer Stat Facts: Non-Hodgkin
Lymphoma. Accessed November 11, 2021. Available at:
https://seer.cancer.gov/statfacts/html/nhl.html.
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