OXFORD, United
Kingdom and MARLBOROUGH, Mass., March 4, 2021 /PRNewswire/ -- Oxford
Immunotec Global PLC (Nasdaq: OXFD) (the "Company"), a global,
high-growth diagnostics company, announced that today it has
released the T-SPOT.COVID test, a CE marked ELISPOT based
test intended for qualitative detection of a cell mediated (T cell)
immune response to SARS-CoV-2 in human whole blood. The company has
filed an EUA request to the FDA for the test.
Serology does not give the full picture of the adaptive immune
response to SARS-CoV-2 infection. Antibodies are not always
produced in response to SARS-CoV-2 infection, or may be
delayed1,2. Antibodies can also wane quickly after
infection4 and reports show T cells may be more long
lived than the antibody response3. In the absence of an
antibody response, the T cell response may be protective from
SARS-CoV-2 infection5.
In a clinical study using samples collected in the US, the
T-SPOT.COVID test was proven to detect a SARS-CoV-2 cell
mediated (T cell) immune response in PCR positive individuals, even
with negative serology test results6. The
T-SPOT.COVID test therefore complements results obtained by
antibody serology to give a more comprehensive view of an
individual's adaptive immune response to SARS-CoV-2 infection. The
test could also be used, for example, alongside serology tests to
support clinical assessment of individuals who present with
suspected COVID-19 but are PCR negative.
In the study, the T-SPOT.COVID test had a positive
agreement with PCR-results of 96.6% (84/87) in SARS-CoV-2 infected
individuals <60 days after first PCR positive result. At >60
days (with the furthest time point after first positive PCR test
result being >240 days) positive agreement remained high at
83.3% (40/48). The T-SPOT.COVID test detected substantially
more people with previous positive PCR results than serology in the
cohort, whose positivity rate was lower and declined faster over
time.
In an endemic cohort of US individuals selected to be at a
relative lower risk of SARS-CoV-2 infection (based on the absence
of self-reported symptoms, negative serology results and no prior
history of a positive PCR test result for SARS-CoV-2) the
T-SPOT.COVID test had a negative agreement of 98.0%
(96/98)6. We cannot exclude the possibility that a
proportion of this group had, or still have, an asymptomatic
infection, seronegative at the time of testing, but in whom the
T-SPOT.COVID test was able to detect a T cell response.
Phill Keefe, Senior VP, Product
Design, Development and Delivery at Oxford Immunotec said, "T cells
and antibodies are two arms of the adaptive immune response. The
detection and measurement of each can provide different insights
about disease activity and an individual's personal immunity."
The Company developed the T-SPOT.COVID test as an
evolution of its T-SPOT® Discovery SARS-CoV-2
assay, a research use only test used to gain insights about the
immune response to SARS-CoV-2.
Dr. Peter Wrighton-Smith, CEO of
Oxford Immunotec, said, "The T-SPOT® Technology platform
is a standardised way of measuring T cells. It has been proven in
clinical use for over 18 years with another major infectious
disease, tuberculosis, which kills around 1.5 million people every
year. Our T-SPOT.COVID test is tailored specifically for the
detection and measurement of an individual's T cell response to
SARS-CoV-2 infection. Having the ability to determine an
individual's immune response to SARS-CoV-2 has the potential to
support a wide range of needs in our battle against the COVID-19
pandemic."
For further information visit www.tspotcovid.com.
Oxford Immunotec has entered in an agreement to be acquired by
PerkinElmer (NYSE: PKI). The transaction is expected to close
shortly.
- Tan W, Lu Y, Zhang J et al. Viral kinetics and antibody
responses in patients with COVID-19. medRxiv. 2020 March 26.
Preprint. https://doi.org/10.1101/2020.03.24.20042382
- Altmann DM, Boyton RJ. SARS-CoV-2 T cell immunity: Specificity,
function, durability, and role in protection. Sci Immunol.
2020;5:eabd6160
- Zuo J, Dowell A, Pearce H et al. Robust SARS-CoV-2-specific
T-cell immunity is maintained at 6 months following primary
infection. bioRxiv. 2020. doi:
10.1101/2020.11.01.362319
- Ibarrondo FJ, Fulcher JA, Goodman-Meza D et al. Rapid decay of
anti-SARS-CoV-2 antibodies in persons with mild Covid-19. N Engl
J Med. 2020; 383: 1085-1087
- Wyllie D, Mulchandani R, Jones HE et al. SARS-CoV-2 Reactive T
cell numbers are associated with protection from COVID-19: A
prospective cohort study. medRxiv. doi:
10.11012020.11.02.20222778
- Package Insert PI-T-SPOT.COVID-IVD-US v3
T-SPOT-COVID-US-PI-v3-1.pdf
T-SPOT, T-Cell Xtend, T-SPOT Discovery
SARS-CoV-2 and the Oxford Immunotec logo, are trademarks of
Oxford Immunotec Limited.
About Oxford Immunotec
Oxford Immunotec Global PLC is a global, high-growth diagnostics
company. We bring energy and invention to a world in need of
diagnostic truth. We are uniquely placed as the only company in the
world offering regulated ELISPOT assays for T cell measurement,
with approval around the globe. Our leading product, the
T-SPOT®.TB test, is used for diagnosing infection
with Tuberculosis, the world's largest cause of death from
infectious disease. The Company has over 18 years' experience as a
manufacturer of IVD tests, operating under a fully audited Quality
Management System, ensuring rigorous batch control. The company has
manufactured in excess of 20 million clinical T cell tests for TB
infection. The T-SPOT.TB test has been approved for sale in
over 50 countries, including the United
States (where it has received pre-market approval from the
Food and Drug Administration), Europe (where it has obtained a CE mark), as
well as Japan and China. The Company is headquartered near
Oxford, U.K. and in Marlborough, MA. Additional information can be
found at www.oxfordimmunotec.com.
About T-SPOT.COVID
Oxford Immunotec has been developing and strengthening its
expertise in T cell measurement for over 18 years since the
introduction of its T-SPOT technology in the field of TB
diagnostics. In that time, we have taken the classic ELISPOT
technique and developed it into the world leading proprietary
T-SPOT technology platform we now use to measure T cell immune
responses, improving performance, standardizing results, and
streamlining the workflow. The ELISPOT technique is exceptionally
sensitive since the target cytokine is captured directly around the
secreting cell making ELISPOT assays much more sensitive than
conventional ELISA assays. The test enumerates effector T cells
responding to stimulation using two separate peptide pools measured
in parallel in individual wells. T-SPOT.COVID antigen panels
are designed as overlapping peptides spanning sequences of the
Spike and Nucleocapsid proteins. This design offers maximum epitope
coverage for enhanced detection of T cell reactivity and no HLA
restrictions. Antigenic formulations of 253 peptides covering the
most immunogenic regions of the virus genome allows measurement of
the breadth of immunity and ensures the impact of point mutations
is minimized. Specificity to SARS-CoV-2 has been enhanced by
removing potentially cross-reactive peptide sequences with high
homology to other coronaviruses.
Forward-Looking Statements
This release contains forward-looking statements that involve
substantial risks and uncertainties. All statements, other than
statements of historical facts, contained in this release are
forward-looking statements. This includes statements about Oxford
Immunotec's anticipated plans and objectives, future performance
and revenues, financial condition, prospects for sales of its
products, growth, strategies, expectations and objectives of
management. Forward-looking statements can be identified by the
fact that they do not relate strictly to historical or current
facts. Forward-looking statements contained in this release reflect
Oxford Immunotec's current expectations and are subject to risks
and uncertainties. Actual results may differ materially from those
projected or implied by forward-looking statements. Other factors
that could adversely affect Oxford Immunotec's business and
prospects are described under the "Risk Factors" section in its
filings with the Securities and Exchange Commission ("SEC"). Oxford
Immunotec's SEC filings are available for free by visiting the
investor section of its website, www.oxfordimmunotec.com, or the
SEC's website, www.sec.gov.
Investors should give careful consideration to these risks and
uncertainties. Forward-looking statements contained herein are
based on current expectations and assumptions and currently
available data and are neither predictions nor guarantees of future
events or performance. Investors should not place undue reliance on
forward-looking statements contained herein, which speak only as of
the date of this release. Oxford Immunotec does not undertake to
update or revise any forward-looking statements after they are
made, whether as a result of new information, future events, or
otherwise, except as required by applicable law.
For Investor Inquiries:
Matt
McLaughlin
Chief Financial Officer
Oxford Immunotec
Tel: +1 (508) 573-9953
mtmclaughlin@oxfordimmunotec.com
For Media Enquiries:
US: Mary Conway
MKC Strategies, LLC
Tel: +1 (516) 606-6545
MConway@MKCStrategies.com
UK: Megan Anderson
ZPB ASSOCIATES
mobile: 07597572287
office: (020) 7018 1124
megan.anderson@zpb-associates.com
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