Oxford Immunotec Global PLC (Nasdaq: OXFD) (the “Company”), a
global, high-growth diagnostics company today announces it has
entered into an exclusive distribution agreement with RIKEN Genesis
Co., Ltd, a subsidiary of The Sysmex Corporation (Sysmex), in
Japan.
Under the agreement, RIKEN Genesis will exclusively distribute
the T-SPOT Discovery SARS-CoV-2 kit (Research Use Only), developed
by Oxford Immunotec for the detection and measurement of SARS-CoV-2
specific T cells, which may offer new insight into immunity to
SARS-CoV-2 infection.
Based on the company’s T-SPOT technology, the only globally
approved ELISPOT currently used clinically for the diagnosis of
Tuberculosis infection; the T-SPOT Discovery SARS-CoV-2 kit is
already available for research use across Europe and the USA. Trial
data recently released by Public Health England1 using the T-SPOT
Discovery SARS-CoV-2 kit suggests that individuals with SARS-CoV-2
specific T cells but without detectible antibodies (serology) may
be protected from infection.
Sysmex are committed to the establishment of diagnosis/treatment
methods for COVID-19 and already offer PCR tests, antigen tests,
and antibody tests. Following a successful trial of the T-SPOT
Discovery SARS-CoV-2 kit in Japan, Sysmex believe offering a T cell
response kit will form an important adjunct to their current range
of tests for COVID-19.
Dr. Peter Wrighton-Smith, CEO of Oxford Immunotec, said “We’ve
been working with RIKEN Genesis for almost ten years now in Japan
and we are delighted to deepen our partnership with this
distribution arrangement for our research use SARS-CoV-2 T cell
test. RIKEN’s strong channel to research customers in Japan will
help broaden usage of our T-SPOT Discovery SARS-CoV-2 kit, which we
believe will be able to make a significant contribution in
informing how we can better manage the ongoing pandemic.”
Dr. Naoto Kondo, President and CEO of RIKEN Genesis, said “We
are excited to start handling T-SPOT Discovery SARS-CoV-2 kit in
Japan. We have provided the T-SPOT technology to Japan market in
strong collaboration with Oxford Immunotec. We hope this kit will
contribute to research support and drug development for COVID19,
especially vaccine development.”
T-SPOT Discovery SARS-CoV-2 is for
research use only, not for use in diagnostic
procedures.
Not all products are available in
all regions; please contact us
for information on availability in any specific
country.
For further information on T-SPOT Discovery
SARS-CoV-2 visit: https://www.tspotdiscovery.com.
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
is an experienced 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 RIKEN
Genesis
Established in October 2007, RIKEN Genesis (a subsidiary of The
Sysmex Corporation) provides products for genetic testing based on
cutting-edge gene analysis technology and laboratory assay services
with the mission of realizing precision medicine using genomic
science and molecular diagnostic technology joined the Sysmex Group
in June 2016 for the practical application of genomic medicine.
RIKEN Genesis provides highly reliable tests based on international
quality standards in laboratories that have obtained CAP
certification / CLIA certification and ISO 15189 certification, and
has a track record in clinical sequence, drug discovery research
support, and clinical research support. Additional information can
be found at the RIKEN Genesis website www.rikengenesis.jp or at The
Sysmex Corporation site https://www.sysmex.co.jp/en/.
About T-SPOT
Discovery SARS-CoV-2
Oxford Immunotec has been developing and strengthening its
expertise in T cell measurement for over 15 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, standardising results, and
streamlining the workflow. This high performance is ensured by our
regularly audited manufacturing facility operating to our rigorous
quality management system. The T-SPOT.TB test, an in vitro
diagnostic (IVD) test using the T-SPOT technology platform, has
been granted regulatory approval for clinical diagnostic use in
over 50 countries, including US, EU, Japan and China. The research
use-only T-SPOT Discovery SARS-CoV-2 assay uses this same T-SPOT
technology to allow SARS-CoV-2-specific T cells to be detected and
enumerated. The optimized antigen mix used in the test is based on
SARS-CoV-2 structural proteins and allows the maximum breadth of
the immune response to be measured. The Companies single
antigen-per-well approach allows specific information about the
immune response to different SARS-CoV-2 antigens to be gathered in
parallel. Sample processing can be centralised whilst still
enabling testing on fresh (rather than frozen) blood, using the
Company’s T-Cell Xtend® reagent (32 h room temperature (RT) sample
stability) or T-Cell Select™ reagent (54 h RT sample stability -
automated processing). The T-Cell Select reagent kit also allows
for automation and therefore accommodates variations in scale -
automation solutions are available for low, medium and high
throughput settings.
T-SPOT, the Oxford Immunotec logo, T-Cell Xtend,
T-Cell Select and T-SPOT Discovery are trademarks of Oxford
Immunotec Limited.
Forward-Looking Statements
Certain statements in this press release constitute
forward-looking statements within the meaning of applicable U.S.
and U.K. laws and regulations, including under the U.S. Private
Securities Litigation Reform Act of 1995. Any statements contained
herein which do not describe historical or current facts, including
beliefs the Company’s distribution arrangement with RIKEN Genesis
to market the T-SPOT® Discovery SARS-CoV-2 kit for the measurement
of the T cell immune response to SARS-CoV-2 infection in Japan will
provide data that provides new insights into immunity to COVID-19,
including the belief that measuring T cells, in conjunction with
other tests, may overcome limitations with the measurement of
antibody-mediated immunity as well as other expected benefits of
the T-SPOT Discovery SARS-CoV-2 test kit, including that the T cell
assay may support efforts to combat COVID-19 and beliefs that the
distribution arrangement will yield important information
constitute forward-looking statements. Any forward-looking
statements are based on our management’s current expectations of
future events and are subject to a number of risks and
uncertainties that could cause actual results to differ materially
and adversely from those set forth in or implied by such
forward-looking statements. These risks and uncertainties include
the possibility that the distribution arrangement will not yield
the expected benefits in a timely manner or at all, or that the
results of the initial data analyses will not contribute to the
study or assisting in COVID-19 efforts as expected; the Company’s
Discovery line of testing might not be a successful or timely tool
in combatting COVID-19, the risk that further research data from
the Discovery test kit will not produce results that support its
clinical use, the likelihood that the Company will be able to
partner with a third party to make a testing device clinically
available and the possibility that, even if ultimately made
commercially available, the testing kit will not be efficacious in
testing for or combatting COVID-19, as well as those other risks
and uncertainties described in Oxford Immunotec’s filings with the
U.S. Securities and Exchange Commission (the “Commission”),
including the Company’s Annual Report on Form 10-K for the
year-ended December 31, 2019 and its Quarterly Report on Form 10-Q
for the quarters ended March 31, 2020, June 30, 2020 and September
30, 2020 and in any other reports it files with the Commission,
including any other Quarterly Reports on Form 10-Q or Current
Reports on Form 8-K. Oxford Immunotec’s filings with the Commission
are available for free by visiting the investor section of our
website, www.oxfordimmunotec.com, or the Commission’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 McLaughlinChief Financial OfficerOxford
ImmunotecTel: +1 (508) 573-9953mtmclaughlin@oxfordimmunotec.com
1 To view the PHE publication visit:
https://www.medrxiv.org/content/10.1101/2020.11.02.20222778v1
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