Adaptive Biotechnologies Announces FDA Emergency Use Authorization for T-Detect™ COVID to Confirm Recent or Prior COVID-19 ...
March 05 2021 - 6:44PM
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 the U.S. Food and Drug
Administration (FDA) issued an Emergency Use Authorization (EUA)
for T-Detect™ COVID to confirm recent or prior COVID-19 infection.
This first-in-class T cell- based test is the first indication
resulting from Adaptive’s TCR-Antigen Map collaboration with
Microsoft (Nasdaq: MSFT).
“We are proud to receive FDA Emergency Use Authorization for
T-Detect COVID, the first indication in an entirely new class of
tests that use T cells in the blood to detect disease. People who
have been unsure about a prior infection will now have another way
to know if they had the virus,” said Chad Robins, chief executive
officer of Adaptive Biotechnologies. “The authorization of T-Detect
COVID represents a true breakthrough for patients and a pivotal
milestone for the diagnostic testing paradigm. We have proven that
it is possible to read how T cells detect disease in the blood, and
this is just the beginning of a pipeline of tests for many other
indications.”
EUA was based on a clinical validation study showing that
T-Detect COVID demonstrated sensitivity of 97.1% from date of
diagnosis using RT-PCR. Sensitivity is the ability of the test to
correctly identify a positive case (true positive). T-Detect COVID
also showed a specificity of 100%. Specificity is the ability of
the test to identify a negative case (true negative).
“This is the first commercially available T-cell test that
confirms recent or prior SARS-CoV-2 infections in people. T-Detect
is accurate and what I find especially remarkable is how rapidly it
was developed. Going from the lab to real-world human impact in a
matter of months demonstrates the true value of our collaboration
and the power of merging biology with cloud-scale machine learning
technology,” said Peter Lee, corporate vice president, Research
& Incubations, Microsoft. “We are hopeful that this technology
will have a meaningful impact not only in the global fight against
COVID-19, but in many other disease areas in the future.”
The FDA provides an EUA for medical products to be used in an
emergency to diagnose, treat, or prevent serious or
life-threatening diseases or conditions when there are no adequate,
approved, and available alternatives.
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 EUA authorized test that is
available for prescription use only.
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 prior 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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