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

Periodic Reporting for period 2 - Lung EpiCheck (Blood Samples and DNA-an Innovative Technique for Lung Cancer Diagnostics)

Reporting period: 2019-11-01 to 2021-04-30

Lung cancer remains a leading cause of death from cancer globally, due to its high incidence and late-stage diagnosis. Most patients are currently diagnosed with late-stage cancer, though research has shown 5-year survival rates are up to 10 times greater when disease is detected early. Annual imaging (low-dose CT scans) is recommended for screening individuals with highest risk, but less than 10% of those eligible adhere to guidelines. Delivering an effective screening option for high-risk individuals could increase compliance for imaging and drive more patients to treatment when it can have the greatest chance of having a long-term benefit.
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.
Liquid biopsies are a new powerful tool in cancer diagnostics that is transforming patient healthcare. Body fluids such as blood or urine are obtained from the patient and analyzed for the presence of circulating tumor DNA which is shed from the cancer. This DNA can tell if cancer is present, its type, effective medications, and more. Liquid biopsies can offer a non-invasive and cost-effective alternative to tissue-based diagnostic tests, as well as providing clear numerical results that are not dependent on human interpretation. However, some tests relying on next-generation sequencing still face high costs and are not easily deployed due to reliance on central lab processing.
Lung EpiCheck is a simple blood test that detects lung tumor DNA circulating in the blood. The test detects subtle disease-specific changes in DNA methylation markers. Lung EpiCheck is an objective molecular test meaning that it does not rely on human interpretation. The result is a clear positive/negative result, with an additional numerical result between 0-100.
DNA methylation is a layer of epigenetic information on top of the DNA sequence. While the DNA sequence in all tissues is almost identical, unique methylation patterns determine each tissue’s biological identity. In cancer there are broad changes in methylation patterns, which makes DNA methylation an excellent type of marker for cancer.
Leveraging PCR-based epigenetics, our pioneering testing approach uses methylation-based identification for early-stage and recurring cancer detection. Our platform delivers highly accurate and sensitive results, all while providing a seamless testing option for patients and the healthcare system. Nucleix was built around DNA methylation expertise, and we were the first to develop a methylation-based tissue identification assay. The EpiCheck assay determines the methylation profile of a liquid biopsy sample in a simple and cost-effective, yet extremely sensitive and accurate manner. EpiCheck can detect extremely rare cancerous molecules on a background of a large number of normal molecules.
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.
The company finalized the 1st generation of the Lung EpiCheck 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 (Low Dose CT), which is a good tool but is yet to be implemented as a standard screening test. The big challenge for it is to pick the right population to be screened by it out of the risk group. Lung EpiCheck is an excellent tool for first line screening for the high-risk population (smokers, people at hazardous occupations etc.), due to its combination of high performance and low cost. Also, being a blood-based test, samples can be collected almost anywhere. Once approved, its effect will be very significant in assisting detection of the disease in early stages, hence to save lives and money.
Receiver operating characteristic carves
Lung EpiCheck product: Current product content
Lung cancer survival rate: Survival rate as a function of the stage in which lung cacner was detecte