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Blood Samples and DNA-an Innovative Technique for Lung Cancer Diagnostics

Periodic Reporting for period 1 - Lung EpiCheck (Blood Samples and DNA-an Innovative Technique for Lung Cancer Diagnostics)

Reporting period: 2018-11-01 to 2019-10-31

Nucleix has developed a highly innovative process for cancer diagnostics. The company plans to introduce Innovative Technique for Lung Cancer Diagnostics via identification of changes in DNA Methylation in Blood Samples. The company has already introduced successfully the Bladder EpiCheck and gained experience in the process of: clinical validation, regulatory approvals and commercialization of bladder cancer diagnostic of cancer via identification of changes in DNA Methylation. Nucleix’s current technology of lung cancer detection in blood samples – Lung EpiCheck - was developed using the same technology and team which has successfully developed Bladder EpiCheck.
Nucleix breakthrough innovations are in the area of cancer detection using a unique combination of a best-in-class biochemical tool, combined with advanced big-data bioinformatics analysis. Lung EpiCheck is a high-potential innovation idea and though having some risk in the process of market adaptation it creates a very high commercial opportunity for Nucleix for growth and a successful mature enterprise
The current high clinical results of Lung EpiCheck and the meetings with European potential customers (such as leading medical centers and lab chains) the project proposed methodology and the expected performance is very promising to potential customers and market leaders. These potential customers have also confirmed company’s assumption about pricing that provides proper value for money. Nucleix’s technology is expected to create a huge value proposition to patients, physicians and payers identified as the main stakeholders. It may be assumed that these stakeholders will use Lung EpiCheck based on its higher value proposition. This creates also an added value for European customers which will be first to use the product and a clear advantage with regards to other key territories. The impact on EU/global challenges is expected to be very significant.

Lung Cancer has the highest rate of mortality amongst cancers, and it is one of the most prevalent cancers. The reason for the high mortality stem from the fact that patients become symptomatic usually at late stages of the disease and there is no good early detection for it. Lung EpiCheck is aimed to solve this issue by introducing a blood-based test that has very good detection of lung cancer.

Earlier detection of lung cancer enables to save lives. The 5 years survival rate of lung cancer patients detected at early stages is about 50% while for those detected at the late stages it is well below 10%. Therefore, early detection will help to save lives, and reduce the cost of treatment for late stage patients

The project objective is to finalize the development of an assay for early detection of lung cancer, transfer it to serial manufacturing and show its efficacy in a clinical trial.
The company finalize its assay and transferred it to manufacturing including setting the quality standards and procedures. In addition wide interaction with key stake holders took place for the positioning of the product post its clinical validation.
Currently the main tool for early detection is imaging which is a good tool but yet to be implemented as a regular routine. The big challenge for it is to pick the right population to be screened by it – out of the risk group. The Lung EpiCheck is a great tool to be the first line screening for people at risk (smokers, people at hazardous occupations etc.), due to its combination of high performance and low cost. Also, being a blood base test, samples can be collected almost everywhere. Once approved its effect will be very significant in assisting detection of the disease in early stages, hence to save lives and save money.
Lung EpiCheck product: Current product content
Lung cancer survival rate: Survival rate as a function of the stage in which lung cacner was detecte