Adaptive Biotechnologies Receives Expanded FDA Clearance for the clonoSEQ® Assay to Assess Minimal Residual Disease (MRD) in...
August 06 2020 - 9:24AM
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 received clearance from the U.S. Food and Drug
Administration (FDA) for its clonoSEQ® Assay to detect and monitor
minimal residual disease (MRD) in blood or bone marrow from
patients with chronic lymphocytic leukemia (CLL). clonoSEQ is the
first and only FDA-cleared in vitro diagnostic for MRD monitoring
in CLL. Today’s clearance expands the existing FDA-cleared uses of
clonoSEQ, as the FDA previously granted the assay De Novo
designation for the detection and monitoring of MRD in bone marrow
from multiple myeloma and B-cell acute lymphoblastic leukemia (ALL)
patients.
Access to clonoSEQ for CLL patients nationwide is supported by
the already-established Medicare coverage of clonoSEQ in CLL, as
well as by the FDA’s clearance of clonoSEQ testing for CLL patients
in blood and marrow. Medicare coverage is critically important in
CLL, as nearly 80 percent of patients living with CLL in the U.S.
are of Medicare age. clonoSEQ’s ability to detect MRD in blood
provides CLL patients and health care providers with a more
convenient and less intrusive option to monitor disease burden.
“FDA clearance of clonoSEQ, which can detect one single cancer
cell among a million healthy cells, is an important milestone for
the CLL community,” said Dr. Brian Koffman, Chief Medical Officer
and EVP of the CLL Society, Inc. “Looking with greater accuracy for
persistent cancer cells can show how well treatment is working and
may help inform important decisions such as changing or stopping
therapy. In my own CLL journey, knowing my clonoSEQ MRD status has
impacted the way my expert team of doctors and I manage my
disease.”
FDA clearance of clonoSEQ in CLL was based on clinical
validation data from two important clinical trials:
- In an analysis of data from the CLL14 study (n=337), patients
with undetectable MRD in blood by clonoSEQ at three months
post-treatment had a nearly seven-fold reduced risk of disease
progression compared with patients who did not reach undetectable
MRD. For purposes of this analysis, an undetectable MRD was defined
at a level of 1 cancer cell among one hundred thousand healthy
cells (10-5).
- Additional evaluation of the data showed that at 30 months
post-treatment, the probability of disease progression for
evaluable patients with undetectable MRD was only 5%, as compared
to 36% for patients with detectable disease.
- In a second study by Thompson et al, clonoSEQ MRD results were
shown to be significantly predictive of outcomes in both blood and
bone marrow samples, regardless of the threshold at which MRD was
assessed.
MRD refers to the remaining number of cancer cells that are
present in a patient’s body during and after treatment, which may
eventually lead to recurrence of the disease. MRD assessment is
performed as a series of tests throughout a patient’s cancer
journey to evaluate prognosis, determine response to treatment,
monitor disease during remission and predict potential relapse.
Controlled trials in CLL as well as other blood cancers have shown
that even the smallest amounts of residual disease can predict a
patient’s long-term clinical outcomes. As novel therapies make
deeper and more durable responses achievable for many blood cancer
patients, clinicians are increasingly utilizing MRD results to help
guide day-to-day patient management.
“We know that traditional CLL treatment response criteria are
insufficient, so the ability to measure MRD with a test that is one
hundred times more sensitive than standard flow cytometry may
change our approach to treating CLL,” said Dr. John Pagel,
principal investigator and Chief of Hematologic Malignancies at the
Swedish Cancer Institute. “A patient’s MRD status gives us timely
information about how a treatment is working, so patients and
providers can be in the driver’s seat when it comes to managing
their disease and treatment decisions.”
The availability of clonoSEQ testing in blood will facilitate
ease of testing for CLL patients, but as the COVID-19 pandemic
continues, some patients may be unable to or may feel anxious about
obtaining a blood draw in a hospital or clinic. To address
this, Adaptive has launched a service offering which will enable
clonoSEQ patients to safely obtain blood draws in alternate
settings. Patients can either access minimal-contact blood
collection services at any of the nearly 2,000 LabCorp Patient
Service Centers in the U.S., or they can have a blood draw
performed by a qualified professional in the comfort of their own
homes through Adaptive’s collaboration with Phlebotek Solutions, a
nationwide provider of mobile phlebotomy services.
“The FDA clearance of clonoSEQ in CLL represents a significant
advancement for patients with CLL,” said Lance Baldo, Chief Medical
Officer of Adaptive Biotechnologies. “We believe this first-time
clearance for clonoSEQ in blood will be advantageous for both
providers and patients. Given the risks that COVID-19 poses for
cancer patients, we are proud to be collaborating with two
best-in-class service providers to offer clonoSEQ patients flexible
and safe options for blood sample collection outside of a hospital
or clinic.”
About the
clonoSEQ AssayPrior to CLL, the
clonoSEQ Assay was granted De Novo designation and marketing
authorization by the FDA for the detection and monitoring of MRD in
patients with multiple myeloma (MM) and B-cell acute lymphoblastic
leukemia (ALL) using DNA from bone marrow samples. clonoSEQ is the
first clinical diagnostic powered by immunosequencing to receive
FDA clearance. clonoSEQ 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.
clonoSEQ is a single-site assay performed at Adaptive
Biotechnologies. It is also available as a CLIA-validated
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 Chronic Lymphocytic Leukemia (CLL)CLL is
a type of cancer in which the bone marrow makes too many
lymphocytes (a type of white blood cell). It is one of the
most common types of leukemia in adults. The disease
often occurs during or after middle age, with the average age of
diagnosis at 70 years old. There were more than 20,000 new cases of
CLL in the U.S. in 2019 and more than 200,000 people in the U.S.
are currently living with CLL. CLL is considered incurable but
5-year and 10-year survival rates are high, such that many people
will require additional treatment over time due to the return of
cancerous cells.
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 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 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.
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
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.
For more information: Beth Keshishian,
Adaptive Media (917) 912-7195 media@adaptivebiotech.com
Karina Calzadilla, Adaptive Investor RelationsCarrie Mendivil,
Gilmartin Groupinvestors@adaptivebiotech.com
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