2019-06-015 - miRFec - Identification and validation of microRNA profiles in fecal samples for detection of colorectal cancer

The miRFec test –a Gradient Boosting Machine-generated algorithm that includes two fecal miRNAs (miR-421 and miR-27a-3p) and fecal hemoglobin concentration, along with age and gender– is more effective and cost-effective than FIT for the identification of patients with advanced colorectal neoplasm (i.e. CRC, AA or advanced serrated lesions [ASL]) among individuals participating in CRC screening programs.

Acronim & Gínjol codes

ACRONYM

miRFec

2019-06-015

Main technology offer

Increased levels of 2 miRNAs and hemoglobin in feces can identify patients with AAs or CRC more accurately than fecal hemoglobin concentration alone

Public Partners

Centres CERCA List
Associated Universities
Other Public Agents

Readiness Level

1-2 Research /
3-4 Experimental PoC /
5 Prototype /
6-7 MVP /
8 Industrialization /
9 Commercialization

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1-First Canvas / 2-Market Analysis / 3-First Validation / 4-MVP / 5-Market Fit / 6-Validate Sales / 7-Final MPV / 8-Validate Business Model / 9-Key Metrics

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1-Market hypothesis / 2-Basic Market / 3-PoC / 4-Target Customer / 5- Customer Validation / 6-Launchable MVP / 7-Customer feedback / 8-Scale product-service / 9-Sustainable business

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Impact: ESG & SDG Goals

Sustainable Development Goals

To reduce the number of unnecessary colonoscopies at the healthcare system and improve sensitivity with respect to current approaches (ie, FIT).

Market Data

There is an emerging need of colorectal cancer screening in the average-risk population. However, current strategies, such as FIT-based screening, have fall due to high false-positive rate, leading to a significant number of unnecessary colonoscopies. On the other, hand, the use of biomarkers as mirFEC is a more sensitive and improved cost/effectiveness strategy.

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Validate the better performance of mirFEC in front the most common approach (fecal immunochemical testing, FIT) in clinical studies. Next, negotiate with Eiken a license agremeent

More sensitive and improved cost/effectiveness strategy to screen colorectal cancer in average-risk population

Screening of average-risk individuals

DeepTech Area

Funding

Not applicable

Not applicable

1. Validating the miRFec test in a multicentric study (phase 1 to establish miRFec score cut-off); 2. Validating the mirFec in a multicentric study (phase 2 to compare results with FIT); 3. License the technology to Eiken

Technology Status

A more sensitive/cost-effective kit for the detection of colorectal cancer

Need a partner to implement the mirFEC technology into their KIT

The mirFEC is currently being validated in a multicentric Study, currently the proposal for a Phase II study is being negotiated. Afterwards, the technology should be licensed to Eiken who will lead the next steps.

National phase in; - Australia P5516AU00; Japó; P5516JP00; Nova Zelanda; P5516NZ - Estats Units; P5516US00; Europa; PCT/EP2020/069918

Eiken is an international company dedicated to sell diagnostic test. Eiken has funded mirFEC project throught several donations and a Research and Cooperation Agreement. This agreement includes a first-right to negotiate a technology license agreement.

Additional information

Increased levels of 2 miRNAs and hemoglobin in feces can identify patients with AAs or CRC more accurately than fecal hemoglobin concentration alone