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™ COVID, the
first clinical T-cell based test to confirm recent or prior
COVID-19 infection. In real-world studies, this first-in-class test
outperformed leading antibody tests.
Knowledge of prior COVID-19 infection is critically important
for those who believe they may have been infected with the virus
but have not been able to confirm a diagnosis. T-Detect is
currently under review by the U.S. Food and Drug Administration
(FDA) for Emergency Use Authorization (EUA).
“The impact of COVID-19 has become its own public health crisis,
with millions of people, like me, who are dealing with serious,
long-term effects of this virus,” said Diana Berrent, founder,
Survivor Corps, the largest grassroots movement in America
dedicated to actively ending this pandemic. “A T-cell test is an
important tool for people who want to know if they had COVID-19 and
may help them to understand and address ongoing health issues. It
is important for patients to participate in ongoing research so
that in the future, the same test may help answer questions about
immunity to and protection from the virus or to a vaccine.”
Patients can order T-Detect COVID online at www.t-detect.com by
answering a few eligibility questions through a secure portal. A
virtual provider will authorize a prescription and patients can
have their blood drawn by a mobile phlebotomist at their home or
they can visit one of nearly 2,000 Labcorp patient service centers.
Patients will receive an email notification when their results are
available, and they can view them via a secure portal.
“T-Detect COVID is the first T-cell test for patients and the
first product resulting from Adaptive’s TCR-Antigen Map
collaboration with Microsoft,” said Adaptive Biotechnologies Chief
Executive Officer, Chad Robins. “By mapping the human immune
response to COVID-19, we have developed a simple blood-based
clinical test to help detect recent or prior infections from our T
cells. This approach will be scaled for more accurate and early
diagnosis of many infectious diseases, autoimmune disorders and
cancer.”
Until now, antibody tests have been the primary way to determine
recent or prior COVID-19 infection. T-cell tests take an entirely
new approach to determine prior infection by looking at a different
but equally important part of our immune system, the T cell. In the
setting of COVID-19, T-cell responses arise earlier than antibodies
and persist in the blood for longer.
Patients ordering T-Detect COVID have the opportunity to
contribute to ongoing research to further the understanding of T
cell-based immunity to COVID-19. This is particularly important as
scientists work to define immunity and establish correlates of
protection to SARS-CoV-2, the virus that causes COVID-19, resulting
from natural infection or vaccination.
About the T cellT cells are the adaptive immune
system’s first responders to detect any virus. They quickly
multiply and circulate in the blood to attack the virus, often
before symptoms appear. Among many other jobs, T cells also recruit
B cells to produce antibodies after about a week or two to
potentially provide immunity against future infection. T cells
contain a treasure trove of information that could provide one
consistent and trackable measure of the immune response to COVID-19
from initial exposure through viral clearance.
T cells can “remember” prior infections and kill pathogens if
they reappear. Research shows that antibodies to SARS-CoV-2 decline
over time. T cells hold important clues to immunity and correlates
of protection and need to be studied to assess how long patients
remain resistant to reinfection. Given T cells circulate freely in
the blood, they are an easy and thus a desirable target for
assessing SARS-CoV-2 exposure and potentially immunity.
About
T-Detect™ T-Detect™ is a highly
sensitive and specific diagnostic test under development for
multiple diseases, 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,
autoimmune disorders and cancer. From a simple blood draw, T-Detect
will leverage the map to provide an immunostatus for an individual,
enabling early disease diagnosis, disease monitoring, and critical
insights into immunity. T-Detect COVID is the first clinical test
launched from this collaboration and the first commercially
available T-cell test designed to detect recent or prior SARS-CoV-2
infections. T-Detect COVID is an in vitro diagnostic that is
available for prescription use only. This test has not been cleared
or approved by the FDA and is available for use as a CLIA-validated
laboratory developed test (LDT). T-Detect COVID is not indicated
for use in patients under age 18. 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 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 Statements This 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
T-Detect COVID and its ability to detect recent or past COVID-19
infection, either in its current form or with respect to future
mutations of the virus, as well as the potential application of
T-Detect 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.
MEDIA CONTACT:Beth
Keshishian917-912-7195media@adaptivebiotech.com
ADAPTIVE INVESTORS:Karina
Calzadilla201-396-1687Carrie Mendivil, Gilmartin
Groupinvestors@adaptivebiotech.com
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