Oxford Immunotec Files Submission to Food and Drug Administration (FDA) for the T-Cell Select™ Reagent Kit
06 November 2020 - 1:00AM
Oxford Immunotec Global PLC (Nasdaq:OXFD) (the “Company”), a
global, high-growth diagnostics company, today announced that it
has filed its FDA submission for the T-Cell Select reagent kit.
“Filing to the FDA for T-Cell Select approval is a critical
first step to bring automation to U.S. customers,” said Dr. Peter
Wrighton-Smith, the company’s Chief Executive Officer. “There is
strong demand from our lab partners and the market to automate the
T-SPOT.TB test cell separation process and this reagent kit opens
the door for laboratories of varying throughput requirements.” The
T-Cell Select reagent kit also improves logistics and laboratory
flexibility, allowing T-SPOT.TB samples to be processed up to 54
hours after collection without field-based incubation or
refrigeration.
The T-Cell Select reagent kit has been available throughout
Europe under CE mark and is quickly becoming available in more
markets around the world.
“This submission builds on our recent FDA clearance of the
T-SPOT.TB test as the only TB blood test cleared for use in
pediatric patients ages two and up, adding workflow improvements on
top of the recent extensions to clinical utility,” said Peter
Wrighton-Smith.
About the
T-SPOT.TB
Test
The T-SPOT.TB test is a single-visit blood test for TB screening
and is one of only two recommended alternatives to the tuberculin
skin test (TST) – otherwise known as purified protein derivative
(PPD) test, or the Mantoux test. The T-SPOT.TB test uses a
standardized sample, reducing the influence of factors in the blood
which may affect performance, and normalizing for cell number
variation. In the U.S., the test has been shown to have a
sensitivity of 95.6% and a specificity in excess of 97.1%, and is
able to maintain performance even in samples otherwise difficult to
test, such as samples from immunosuppressed patients and
BCG-vaccinated patients.1
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.
T-SPOT, T-Cell Select and the Oxford Immunotec logo 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. Such forward-looking
statements may be identified by words such as “anticipates,”
“believes,” “expects,” “plans,” “intends,” “projects,” and “future”
or similar expressions that are intended to identify
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 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.
CONTACTS:
For Media and Investor Inquiries:Matt
McLaughlinChief Financial OfficerOxford ImmunotecTel: +1 (508)
573-9953mtmclaughlin@oxfordimmunotec.com
[1] Oxford Immunotec. T-SPOT.TB Package Insert PI-TB-US-0001 V8.
Abingdon, UK. September 2020.
Oxford Immunotec Global (NASDAQ:OXFD)
Historical Stock Chart
From Apr 2024 to May 2024
Oxford Immunotec Global (NASDAQ:OXFD)
Historical Stock Chart
From May 2023 to May 2024