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Ensayo de diagnóstico mejorado para colocar sondas nasogástricas

Resumen

Tipo:
Oferta Tecnológica
Referencia:
TOUK20160324002
Publicado:
06/04/2016
Caducidad:
06/04/2017
Resumen:
Una pyme británica ha desarrollado un nuevo ensayo fácil de usar, asequible y sensible/específico para colocar sondas nasogástricas. Cada año se utilizan millones de sondas nasogástricas por los servicios sanitarios de la UE. Una colocación incorrecta de las sondas supone un importante problema en pacientes y hospitales. El objetivo es resolver este problema y reducir el coste de las radiografías. La empresa busca socios para gestionar la evaluación clínica en hospitales o adoptar el ensayo y diseñar, desarrollar, comercializar, distribuir y vender los kits de diagnóstico.

Details

Tittle:
Improved Diagnostic Assay for Nasogastric Feeding (NG) Tube Placement
Summary:
Each year millions of nasogastric (NG) feeding tubes are used by EU health services. NG tube misplacement is a significant problem for patients and hospitals. To address this issue and reduce the cost of confirmatory x-rays a UK SME has developed a novel test for NG tube placement that is easy to use, low cost, sensitive/specific. They are seeking partners to enable/manage hospital clinical evaluation/adoption of the assay and/or to design, develop, market, distribute and sell diagnostic kits
Description:
An estimated 10 million nasogastric (NG) feeding tubes are purchased by EU health services providers each year with 1.5 bn feeding tubes used worldwide. NG feeding tube use is growing 7%/year, more rapidly in territories with a significantly aging populations. NG feeding tube misplacement is a significant problem for hospitals/healthcare providers in Europe.

A 2010 UK National Health Service report on deaths and severe harm associated with misdirecting NG feeding tubes into the lungs identified misinterpretation of placement assays, including chest x-rays, as the most common reason for placement errors.
Current healthcare guidelines recommend safety checks, based on a pH test of tube aspirates, to define an upper pH cut-off for safe NG tube feeding, beyond which a confirmatory chest X-ray is required. To compound the situation, across the EU up to 42% of hospital patients receive antacid medications that can render the results of low pH test paper falsely negative. Consequently, according to most EU national medical guidelines, patients on antacid medication receiving NG tube-mediated feeding require a chest x-ray each day to confirm correct tube placement. However, daily chest radiography is undesirable because this increases radiation exposure to patients and represents significant additional costs/time to healthcare providers. In the EU it is estimated that every year >65 million pH-based diagnostic tests for NG feeding tube placement are at risk of being compromised by the effects of antacid medications alone, each requiring a confirmatory X-ray that costs, on average, -Y-euro;120 per x-ray.

The test described here is based on detecting the formation of an organic acid that is released (from a chemical ester substrate impregnated onto modified pH paper) by the action of a stomach-specific biomarker - the human gastric lipase (HGL) enzyme (figure 1). The enzyme-based diagnostic test, being potentially more accurate than currently available alternatives, could reduce reliance on expensive chest x-rays to confirm NG feeding tube placement.

If just 25% of NG feeding tube placement X-rays could be avoided then the annual direct costs savings to EU healthcare providers in x-ray treatment alone would be a >-Y-euro;400 million/yr.

Seeking a variety of partners and cooperation types, including; manufacturing agreement, commercial agreement with technical assistance, research cooperation and license agreement.
Advantages and Innovations:
The UK SME have addressed this NG feeding tube placement verification problem by creating a proprietary enzyme biomarker-based ´yes/no´ diagnostic test for the accurate diagnosis of tube positioning. The assay is
-simple,
-easy to use,
-low cost
-has high sensitivity/specificity.
- requires no alteration to current end-user medical practitioners
- no additional training for its deployment in clinical practice

The test is based on detecting the formation of an organic acid that is released (from a chemical ester substrate impregnated onto modified pH paper) by the action of a stomach-specific biomarker - the human gastric lipase (HGL) enzyme . The enzyme-based diagnostic test, being potentially more accurate than currently available alternatives, could reduce reliance on expensive chest x-rays to confirm NG feeding tube placement. In a hospital feasibility study they detected a significant improvement in the accuracy of confirming stomach placement of NG feeding tubes when using pilot batches of tributyrin impregnated onto commercially available pH strips compared with the standard pH test that is currently in clinical use. In these studies they observed reproducible HGL-mediated pH reduction using ester impregnated pH paper. In the hospital pilot study (n= 23, including 15 patients on antacid medications) the new diagnostic test was found to be 100% accurate in detecting NG feeding tube placement. The initial estimates suggested that the use of the diagnostic assay could reduce the need for confirmatory chest x-rays by at least 30%.
Stage of Development:
Project already started
IPs:
Granted patent or patent application essential
CommeR Statunts Regarding IPR Status:
USA

Partner sought

Type and Role of Partner Sought:
The UK SME are seeking industry or clinical collaborators to enable hospital clinical evaluation/adoption of the feeding tube placement assay in Europe and/or as a co-development partners to design, develop, market, distribute and sell diagnostic kits in Europe.

Client

Type and Size of Client:
Industry SME 11-49
Already Engaged in Trans-National Cooperation:
Si
Languages Spoken:
English
French
German
Italian
Spanish

Dissemination

Restrict dissemination to specific countries:
Armenia, Belarus, Cameroon, Canada, Finland, Iceland, Israel, Italy, Latvia, Lithuania, Malta, New Zealand, Singapore, Slovakia, Taiwan, Province Of China, Viet Nam

Keywords

Technology Keywords:
06001005 Diagnósticos, diagnosis
06001010 Gerontología y geriatría
06001007 Medicina de urgencias
06001021 Productos de un único uso y bienes de consumo
06001022 Tejidos textiles para medicina