Hemoglobin as a biomaker for early cancer – project proposal to NIHR ((ISSN 2753-8176 (online)

Ana Pedro (1)

1 Gwyntwr1386 Pharmacy, Regus Chester Business Park, Heronsway, Chester, CH49QR, UK

info@gwyntwr1386.com

Details of innovation

Name of innovation

Hemoglobin as a biomaker for early cancer

Please select the innovation sector

In-vitro diagnostic

Please provide a brief description of the innovation including relevant disease area(s) and target patient and service user population(s)

A large body of evidence supports a role for haemoglobin not only in BC diagnosis but also in cancer diagnosis in general (1):

- THC and different hemoglobin subunits seem to be associated with cancer progression and response to cancer treatment

- Hypoxia also seem to be associated with cancer progression and response to cancer treatment

- HBB seems to increase cancer cell aggressiveness

- HbA1c seems to be related with cancer, which might be related with cancer cell metabolic shift through a mechanism not very well defined

- Hemoglobin can be tumor - derived and might be selectively deregulated to promote cancer cell survival

Here, we propose the development of a whole-blood hemoglobin LFA to detect the presence of cancer.

1. Pedro A (2023). THE ROLE OF HEMOGLOBIN IN CANCER – AN OPINION

ISSN 2753-8176 (online), DOI:10.13140/RG.2.2.17696.97281

Please provide a brief description of the unmet need or health care problem you are looking to address and how you think your innovation will solve or improve on the current standard of care. Please include the potential benefits you’ve identified for patients and service users i.e sustainability, cost savings, supporting underserved populations, addressing health inequalities/barriers etc.

Currently NHS cancer screening might be very complicated and not cost effective such as screening mammography or bowel cancer screening or cervical screening. A simple whole-blood hemoglobin LFA would be available in pharmacies and would be very use to use and would be very cost effective.

How is your innovation different to existing innovations, please include any competitor you have identified?

Currently NHS cancer screening might be very complicated and not cost effective such as screening mammography or bowel cancer screening or cervical screening. By other sides, cancer tests like the Trucheck Tests are very expensive, need lab work and results only come in 2 weeks (2) whereas with a whole blood hemoglobin LFA test we could get the result in minutes.

https://www.thecancerscreeningtrust.co.uk/screening-tests2.

Stage of development

Please answer the appropriate questions relevant to your innovation sector

What is the current stage of development?

• Pre-clinical

Please refer to the information below and indication your current development stage

Technology readiness level (TRL) - 4

• TRL-1Basic research: idea, unproven, concept, no testing

• TRL-2 Basic research: concept and application formulated

• TRL-3Preclinical research: First laboratory tests completed

• TRL-4 Preclinical research: Small scale prototype built in a lab

• TRL-5 Manufacturing validation/late preclinical: Large scale prototype tested in an intended environment; simulation safe

• TRL-6Clinical research: Prototype system tested in an intended environment close to expected performance

• TRL-7 Clinical research: Demonstrate system operating in an operational environment at pre-commercial scale

• TRL-8 Regulatory clearance and market preparation: First of kind commercial system; manufacturing process outlined

• TRL-9 Regulatory clearance and market preparation: Full commercial application: technology available for consumers

• TRL-10 Post launch: Product marketed; generation of real world evidence/impact evaluation

TRL-6-9 cover the regulatory approval stages

Please provide a brief description of the research proposed, including any research questions you are looking to answer and what you aim to get out of the research. Please include any questions you would like to ask potential collaborators from the research network.

What evidence or data have you generated so far and can the findings/results or publication be shared with researchers in the NIHR network?

1. Collect 100 control plasma samples (NIHR bioresource) + Welsh cancer bank tumor plasma samples

2. Quantitative Proteomics analysis (Liverpool University)

3. Develop whole-blood LFA test (Gwyntwr1386 Pharmacy)

4. Commercialize, clinical phase (Gwyntwr1386 Pharmacy)

Contact Information

Please provide the details of the main person(s) of contact for this project.

Company nameGwyntwr1386 Pharmacy

Company address101A Regus Chester Business Park, Chester, CH4 9QR

Which country is the company located in?

Website www.gwyntwr1386.com

Contact name Ana Pedro

Contact job title Director

Contact email address info@gwyntwr1386.com