26th Nov 2008 15:13
Tepnel Life Sciences plc ('Tepnel' or 'the Company')
State of Illinois Selects Tepnel's Cystic Fibrosis Test for
Mandated Screening of all Newborns
Manchester, UK, 26 November, 2008 -- Tepnel Life Sciences PLC (AIM: TED) today announced that the Illinois Department of Public Health has selected its Elucigene™ CF-US test for two-stage testing for cystic fibrosis (CF) as part of a new mandate to screen all newborns for the disease. Cystic Fibrosis is the second most common life-shortening genetic disorder in the United States, and it is estimated that 50 babies are born in Illinois each year with the condition. Studies show an early diagnosis of CF can save between $250,000 and $1,250,000 of medical costs per CF patient depending on the severity of the disease.
The Illinois Department of Health began initial testing and validation of Tepnel's CF-US assay in January of 2008 and implemented the test earlier this year. The first stage of screening calls for all newborns to be tested for elevated levels of immunoreactive trypsin (IRT) using a small blood sample from a small puncture to the infant's heel collected on special filter paper. Infants with IRT levels in the top 4% of the daily assay run, are tested for CF mutations using the CF-US assay.
Infants who screened positive for one or two mutations or with extremely elevated IRT levels are referred for a confirmatory diagnosis by sweat testing and those confirmed to have CF by a positive result are seen immediately by members of a cystic fibrosis team for initiation of appropriate care.
In addition to the 23 mutations recommended for screening by the American College of Medical Genetics and the American College of Obstetricians, CF-US detects a number of mutations more commonly found in the Hispanic and African American populations.
"We are excited to work with the Illinois Department of Public Health on this significant public health concern. The successful implementation of the CF-US assay in the Illinois Newborn CF Screening Program in such a short period of time demonstrates the ease and utility of the Elucigene CF-US assay," said Ben Matzilevich, Chief Executive Officer, Tepnel Life Sciences.
Matzilevich added, "According to the March of Dimes, the US non-profit organization dedicated to fighting birth defects, there are large disparities among American states for newborn screening tests. We believe that the successful implementation of Tepnel's CF-US assay by the Illinois Newborn Screening Program will encourage more states to implement statewide screening programs."
Approximately four million infants are born annually in the United States of whom an estimated 150,000 are born with serious birth defects (3.75%).
The Elucigene CF-US test, from Tepnel's Molecular Diagnostics division, is designed for high sample throughput using a capillary sequencer and detects 44 mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene as well as their wild type counterparts.
For Further Information:
Tepnel Life Sciences plc
Carol Smith, Group Marketing Communications Manager
0161 946 2200
Capital MS&L
Mary Clark or Joey Whineray
Tel: +44 20 7307 5330
Seymour Pierce Limited
Mark Percy
Tel: +44 20 7107 8000
Notes to Editors
About Tepnel Life Sciences plc
Tepnel Life Sciences (AIM:TED) is a UK-based international life sciences products and services Group with two divisions, Molecular Diagnostics and Research Products & Services. The Company has laboratories, manufacturing and operations in the USA, UK and France with over 200 employees. Tepnel provides test kits, reagents and services to two highly synergistic markets, these being Molecular Diagnostics and Biomedical Research. The Company's strategy has been to identify high growth niche opportunities within these multi-billion pound markets. Tepnel focuses on these niche operations with internally developed products, patents, expertise and know-how as well as strategic acquisitions, to develop a leadership position within these defined market segments. For more information please visit www.tepnel.com.
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