Oxford Immunotec Announces CE Mark Approval for T-SPOT.CMV Test
(Thomson Reuters ONE) -
Product to be Featured at a Symposium at the European Congress of Clinical
Microbiology and Infectious Disease
OXFORD, UK and MARLBOROUGH, Mass., April 27, 2015 (GLOBE NEWSWIRE) -- Oxford
Immunotec Global PLC (Nasdaq:OXFD), a global, commercial-stage diagnostics
company focused on developing and commercializing proprietary tests for the
management of immune-regulated conditions, today announced that it had gained CE
Marking for its T-SPOT(®).CMV test.
"We are pleased our T-SPOT.CMV test gained CE Mark approval earlier than our
expectations," said Dr. Peter Wrighton-Smith, Chief Executive Officer of Oxford
Immunotec. "While we are enthusiastic about the potential clinical and economic
value T-SPOT.CMV may provide in transplant medicine we are taking a measured
approach to market introduction as we await the results of our PROTECT and REACT
clinical trials. We continue to expect full commercial launch in the second half
of 2016."
T cell immunity against cytomegalovirus (CMV) is a factor in controlling viral
latency and susceptibility to CMV disease. CMV can affect individuals with
weaknesses in their T cell response and it is therefore an important and common
cause of morbidity and mortality in solid organ and hematopoietic stem cell
transplant recipients. The T-SPOT.CMV test measures the strength of T cell
responses to CMV specific antigens. The T-SPOT.CMV test has the potential to
assist clinicians with monitoring anti-viral prophylaxis and evaluating patients
at risk from CMV disease.
"Measuring T Cell Mediated CMV / TB Response with ELISPOT Technology" is the
subject of an integrated symposium that will be held tomorrow, April 28, at the
European Congress of Clinical Microbiology and Infectious Diseases (ECCMID)
meeting in Copenhagen, Denmark. Investigators Dr. Roy Chemaly and Dr. Oriol
Bestard Matamoros will be presenting their experience using the T-SPOT
technology for immune monitoring and T cell response to CMV in hematopoietic
stem cell transplant patients and solid organ transplant patients.
The T-SPOT.CMV test leverages Oxford Immunotec's proprietary T-SPOT technology
platform, and is the first in a series of planned new products intended to help
transplant patients and physicians manage immune regulated conditions. The test
is available now as a CE-marked kit in the EU, and will soon be available in the
UK as a testing service from our UK ODL laboratory. T-SPOT.CMV is also available
in the US as a Laboratory Developed Test from the Company's CLIA-certified and
CAP accredited ODL service laboratory(1).
About Oxford Immunotec
Oxford Immunotec Global PLC is a global, commercial-stage diagnostics company
focused on developing and commercializing proprietary tests for the management
of immune-regulated conditions. The Company's first product is the T-
SPOT.TB test, which is used to test for tuberculosis 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 T-SPOT.CMV test is the Company's second product and the
first in a series of products intended for the transplantation market. Overall,
the Company has six active development programs, each of which leverages our T
cell and innate immune measuring technology. The Company is headquartered near
Oxford, UK and in Marlborough, MA. Additional information can be found at
www.oxfordimmunotec.com.
T-SPOT and the Oxford Immunotec logo are trademarks of Oxford Immunotec Ltd.
1. The T-SPOT.CMV test is pending approval in California, New York and Florida
CONTACTS:
For Media Inquiries:
Caroline Crawley
Oxford Immunotec
Tel: +44 1235 442796
ccrawley(at)oxfordimmunotec.com
For Investor Inquiries:
Rick Altieri
Chief Financial Officer
Oxford Immunotec
Tel: +1 (508) 573-9953
raltieri(at)oxfordimmunotec.com
Mark Klausner
Westwicke Partners
Tel: +1 (443) 213-0500
oxfordimmunotec(at)westwicke.com
This announcement is distributed by GlobeNewswire on behalf of
GlobeNewswire clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Oxford Immunotec via GlobeNewswire
[HUG#1915258]
Unternehmensinformation / Kurzprofil:
Datum: 27.04.2015 - 13:02 Uhr
Sprache: Deutsch
News-ID 388683
Anzahl Zeichen: 5060
contact information:
Town:
Oxfordshire
Kategorie:
Business News
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