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 the launch of T-Detect™ Lyme.
This is the company’s second test to be made available from its
growing T-Detect franchise. The T-Detect test detects an immune
response by leveraging the body’s unique T-cell response to
disease-associated antigens. T-Detect Lyme identifies T cells
activated by Borrelia burgdorferi, the bacterium that causes Lyme
disease, to help diagnose early Lyme disease.
T-Detect Lyme, administered as a simple blood test, is intended
to aid in the diagnosis of early Lyme disease in adult patients
demonstrating signs and symptoms. These symptoms include, but are
not limited to, the presence of an Erythema migrans (EM) rash,
fever, chills, headache, fatigue, muscle and joint aches, and
swollen lymph nodes.
“The T-Detect franchise leverages the immune system’s natural
abilities and the exquisite specificity of T cells to detect
disease early. The availability of T-Detect Lyme may help shorten
the time to accurate diagnosis for patients with early Lyme
disease. Also, the addition of T-Detect Lyme will support scaling
clinical operations to enable our growing T-Detect portfolio,
including testing in autoimmune disorders with high unmet need,”
said Sharon Benzeno, Ph.D., chief commercial officer, immune
medicine, Adaptive Biotechnologies. “T-Detect Lyme has demonstrated
greater sensitivity than serology in early Lyme disease and may aid
in the early diagnosis of up to two times more cases that may be
missed by traditional serology testing. We aim to further improve
the test sensitivity over time using new data sets from additional
individuals to be able to help more patients.”
In the U.S., Lyme disease is the most common tick-borne illness,
with approximately half a million newly infected people per year.1
An early diagnosis of Lyme disease facilitates treatment initiation
to stop disease progression. However, today’s standard antibody
tests may miss up to 75% of Lyme disease cases in the acute, or
early, phase of infection.2
In a clinical validation study among patients with early Lyme
disease, the T-cell test was more accurate than leading antibody
tests.3 T-Detect Lyme has a specificity of ~99% and showed more
than 1.5 times greater sensitivity than standard two-tiered testing
(STTT) in patients who presented with a bullseye rash (54% vs 30%,
respectively).3 In a separate study, T-Detect Lyme showed three
times greater sensitivity than STTT in the first four days after
symptoms appeared (44% vs 14%, respectively).4
“Lyme disease is a particularly burdensome illness, and the
areas where Lyme disease is common are expanding,” said Dr. Shari
Rozen, a doctor at Preferred Primary Care Physicians of Pittsburgh,
and investigator for the ImmuneSense™ Lyme Study. “The
development of antibodies takes time; however, the majority of
serologic tests are requested in the early stages of infection,
when STTT sensitivity is lower. A T-cell test can improve upon
existing options for patients and healthcare providers by measuring
a different aspect of the immune response, the T cell, which can
arise earlier than antibodies to help identify recent
infections.”
T-Detect Lyme is the latest application of Adaptive’s immune
medicine platform, which uses Adaptive’s TCR sequencing
capabilities and Microsoft’s cloud-scale AI to characterize the
T-cell repertoire and identify a clinical signal for disease.
Adaptive is applying this approach to enable earlier and more
accurate diagnosis of many infectious diseases and autoimmune
disorders. In early 2021, Adaptive Biotechnologies received
Emergency Use Authorization (EUA) from the U.S. Food and Drug
Administration (FDA) for the first diagnostic application of the
platform, T-Detect COVID, which has been used by over 30,000
patients to confirm recent or prior SARS-CoV-2 infection.
T-Detect Lyme is available to patients with a prescription
through a qualified healthcare professional as a Clinical
Laboratory Improvement Amendments (CLIA) laboratory-developed test
(LDT) service. Healthcare professionals interested in learning more
about T-Detect Lyme or ordering it for their patients can contact
T-DetectInquiries@adaptivebiotech.com or call 833-833-8328.
About
T-Detect™T-Detect™ is a clinical
test from Adaptive Biotechnologies that uses the power of T cells
to give us information about a person’s adaptive immune response.
T-Detect COVID, the first-ever T cell-based clinical test to
receive FDA emergency use authorization (EUA), can determine
whether a person has had a recent or prior adaptive immune response
to SARS-CoV-2. T-Detect Lyme, available as a CLIA-validated LDT, is
intended to aid in the diagnosis of early Lyme disease.
COVID-19 and Lyme disease are the first of many potential
diseases Adaptive hopes to detect by looking at the T-cell
response. It’s our goal to use future versions of T-Detect to help
diagnose many different illnesses, translating the natural
diagnostic capability of T cells into clinical practice. In 2018,
Adaptive and Microsoft partnered to build a map of the immune
system called the TCR-Antigen Map. This approach uses
immunosequencing, proprietary computational modeling, and machine
learning to map T-cell receptor sequences to disease-associated
antigens for infectious diseases and autoimmune disorders. From a
simple blood draw, T-Detect aims to leverage the map to enable
early disease diagnosis, disease monitoring, and critical insights
into immunity.
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 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.
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 statements regarding our 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, including forward-looking
statements contained in this press release or elsewhere related to
products in the T-Detect franchise and their respective abilities
to diagnose or detect diseases such as Lyme disease or recent or
prior COVID-19 infection, as well as the potential application of
T-Detect franchise products to additional disease states.
In some cases, you can identify forward-looking statements by
the words “may,” “will,” “could,” “would,” “should,” “expect,”
“intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,”
“project,” “potential,” “continue,” “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 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.
References
- Centers for Disease Control and
Prevention (CDC). Lyme Disease, Data and Surveillance. Available
at: https://www.cdc.gov/lyme/datasurveillance/index.html. Accessed
June 6, 2022.
- Marques AR. Revisiting the Lyme
disease serodiagnostic algorithm: the momentum gathers. J Clin
Microbiol. 2018 Jul 26. doi:10.1128/JCM.00749-18.
- Data on file. Adaptive
Biotechnologies. 2022.
- Greissl J, et al. Immunosequencing
of the T-cell receptor repertoire reveals signatures specific for
diagnosis and characterization of early Lyme disease. medRxiv. 2021
Aug 2. doi:10.1101/2021.07.30.21281353.
ADAPTIVE INVESTORSKarina Calzadilla, Vice
President, Investor Relations201-396-1687Carrie Mendivil, Gilmartin
Groupinvestors@adaptivebiotech.com
ADAPTIVE MEDIALaura
Cooper205-908-5603media@adaptivebiotech.com
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