Preliminary Data from Real-World Study Demonstrate T-cell Testing Outperforms Antibody Testing in Identifying Past SARS-CoV-2...
November 13 2020 - 8:00AM
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 its T-Detect™
Assay for past SARS-CoV-2 infection in development identified 97%
(68/70) of past PCR-confirmed SARS-CoV-2 infections compared to 77%
(54/70) with commercial EUA approved antibody testing at similar
specificity approximately two months after PCR diagnosis.
Additionally, the T-cell response was greater in symptomatic versus
asymptomatic subjects, whereas there was no correlation between
antibody levels and disease severity in recovered patients.
Preliminary results of this study, performed in collaboration with
University of Padua and Ospedale San Raffaele in Milan, who were
funded by a grant from Umberto Veronesi Foundation were made
available on medRxiv. T-Detect™ COVID will be launched later this
fall, becoming the first clinical T-cell based diagnostic test able
to confirm past infections to SARS-CoV-2.
It is likely that some people may never develop antibodies to
SARS-CoV-2 because they can resolve the infection early and
effectively with T cells. Recent studies have demonstrated that
antibodies appear to wane over time¹, while virus-specific T cells
have been shown to persist for at least six months². This new study
adds to mounting evidence that T cells, along with antibodies, may
serve as an important correlate of immune protection and can help
provide a more complete picture of the duration of immunity to the
virus following an infection or administration of a vaccine.
“These data add to the growing body of real-world evidence that
the T cell plays a critical role in immunity to SARS-CoV-2,” said
Lance Baldo, Chief Medical Officer of Adaptive Biotechnologies. “T
cells are emerging as another key indicator for past infection and
immunity to the novel coronavirus, and a T-cell test for patients
that is accurate and reproducible can serve large populations of
people given what we are learning about the biology of the immune
response.”
An initial study published in Nature in June 2020 was conducted
by the University of Padua in which nearly the entire population of
Vo’, Italy (2,900 of the town’s 3,275 residents), was tested using
PCR for SARS-CoV-2 infection at the beginning and end of a 14-day
lockdown of the town, followed by longer-term clinical monitoring.
At that time, 81 people in the town tested positive for the virus
in at least one of the two surveys. Interestingly, more than 40% of
those who tested positive were asymptomatic, guiding the town’s
response to the then-emerging pandemic and driving their success in
containment³.
In a follow-up study of 2,290 residents, including 70 of the 81
who tested positive by PCR, antibody testing with a EUA approved
commercial test (IgG) and T-cell testing with Adaptive’s T-Detect
Assay for past SARS-CoV-2 infection were performed approximately 60
days after PCR testing. The T-cell assay identified 97% (68/70) of
past PCR-confirmed SARS-CoV-2 infections compared to 77% (54/70)
with the antibody test. Notably, 24 of the 70 PCR -positive
patients were asymptomatic, highlighting the added sensitivity of
T-cell based testing to provide a more accurate representation of
past infection in a community. The T-cell response was measured by
the overall quantity of T cells as well as the number of unique
virus-specific T cells. Convalescent subjects who were symptomatic
and hospitalized with COVID-19 had significantly greater T-cell
response than asymptomatic subjects, while antibody levels did not
correlate with disease severity.
Notably, an additional 45 (2.0%) of PCR-negative participants
tested positive with the T-Detect Assay for past SARS-CoV-2
infection. About half of these individuals had reported symptoms
before or after PCR testing or a household exposure, indicating the
T-cell assay may also identify past infections that had been missed
by prior PCR testing.
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 will be the first clinical
test launched from this collaboration and the first commercially
available T cell test designed to detect past SARS-CoV-2
infections. It is expected to launch this fall.
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
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 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.
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, including
statements regarding T-Detect™ and its launch, potential commercial
acceptance, or clinical utility, either with respect to COVID-19 or
other disease states. 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, including a Quarterly Report on Form
10-Q to be filed later today. 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.
ADAPTIVE MEDIABeth
Keshishian917-912-7195media@adaptivebiotech.com
ADAPTIVE INVESTORSKarina Calzadilla, Vice
President, Investor Relations201-396-1687Carrie
Mendivil, Gilmartin Groupinvestors@adaptivebiotech.com
___________________________________¹ Ward, et al.medRxiV
preprint, 2020 ² Zuo, et al. bioRxiV preprint, 2020³ Lavezzo, et
al. Nature, 2020
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