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Molecular diagnostic technology

340 2022. 6. 10.
Molecular diagnostic technology

Summary

The Korean company specialized in molecular diagnostic and owns 0.01% detection sensitivity technology, is looking for partners in the EU. The company was established in 2016 and has developed the proprietary technology which has resolved the amplification error of the PCR process and achieved a detection sensitivity of around the 0.01%. With this high-performance, their kit could be used for Cancer Diagnosis including monitoring, therapy decision, and the MRD (minimal residual disease). Now, the company is looking forward to the opportunity to support the development of cancer drugs through companion diagnostics with pharmaceutical companies.

Advantages and Innovations

1. There is an unmet need in the cancer treatment market

1)Even the cancer treatment has advanced rapidly, selecting the optimum treatment for each patient is not always possible. 

2)To provide personalized cancer treatment for all cancer patients, an exact diagnosis is required.

3)According to the research, around 0.01% detection sensitivity is necessary for providing personalized cancer treatment to early-stage cancer patients, but the detection sensitivity of conservative products is around 0.1%.

 

2. Their technology can resolve the detection sensitivity issue by removing the amplification error. 

1)The fundamental reason for low detection sensitivity is the mis-match amplification.

2)The company found the solution to the amplification error from the polymerase. It only amplifies the mutation gene and leaves wild type gene intact.

3)To stabilize the performance of the polymerase, they also developed the optimized buffer system and primer-probe design know-how. 

4)With these efforts, the detection sensitivity of the system is up to 0.00001%, and the detection sensitivity of commercialized products is around 0.01%, which is enough to diagnose primary cancer.

 

3. Their technology will change the cancer-treatment paradigm.

1)Due to superior performance, their technology can expand precision medicine to all stage cancer patients.

2)The high detection sensitivity of their technology makes the validation of drug candidates easier, reduces the development cost, and raises the whole process's efficiency. 

3) Accordingly, personalized treatment and medical service can be provided to all stage cancer patients, and the quality of cancer patients' life can also be improved.

Stage of Development

TRL 9 - Already on the market

Description

The company was founded in November 2016 by Mr. Lee, an adjunct professor of Pharmacology at Korea University. With over 20 years of experience in this field, he has achieved many patents in the diagnosis field. To pursue a more professional management system, the company engage Mr. Baek as the CEO after the establishment. Accordingly, the company is currently managed by two CEO, Mr. Lee is in charge of the R&D department, and Mr. Baek is in charge of the business department. 

 

Because the company is R&D oriented company, they consist of specialists in molecular biology, biochemistry, and pharmacology. Additionally, QM experts from various fields are working together to warranty the technical quality.

 

Since its establishment date, the company has developed the proprietary technology. To protect its intellectual property right, they registered 13 patents, and 14 patents are in process. 

 

For commercializing their technology, the company is conducting three clinical trials to evaluate the efficacy of their technology with famous medical centers in South Korea. The study subject is related to the lung cancer, pancreatic cancer, and colorectal cancer, and the paper will be published in 2022.

 

Regarding the regulatory, we got 2 CE-IVD for the EGFR mutation test kit and BRAF mutation test kit and are proceeding with the FDA approval of EGFR now. Additionally, the comapny is also preparing for the IVDD-IVDR transition.

 

To generate revenue, the company has already concluded the distribution agreement with several countries in North America and Europe. Moreover, to expand the business area, the company is in the early stage of business discussion with several laboratories in the United States for LDT service and proceeding with the licensing out agreement with a big molecular diagnostic company in the United States. 

 

The company is looking for pharmaceutical companies in Europe that would be a partner in companion diagnostic projects. 

Technology Keywords

6.1.6 Diagnostics, Diagnosis

Market Application Keywords

5.1 Diagnostic
5.1.8 Diagnostic test products and equipment

Sector Group

Others

Type and Size of Client

Industry SME 11-49

Type and Role of Partner Sought

Pharmaceutical companies are interested in companion diagnostic projects about tyrosine kinase inhibitors. The company is looking for any type of partners. (R&D, Investment, etc.)

Type of Partnership Considered

Research cooperation agreement

Company

Genecast

Internal Reference

RDR20220002

Category

RDR

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