Gencurix Publishes Companion Diagnostics Technology with Reflection of Quality of Nucleic Acid Samples in International Journal

Gencurix to establish a new paradigm for companion diagnostics Companion diagnostics technology for independent nucleic acid quality criterion (iQC index) reflecting the nucleic acid quality derived from formalin-fixed, paraffin-embedded (FFPE) is published in ‘Scientific Reports’, which is affiliated with the well-known journal, Nature

Gencurix Co. Ltd. (KONEX:229000) announced that the nucleic acid quality index (iQC index), allowing the measurement of the quality of the nucleic acid in molecular diagnosis is published in the Journal of Scientific Reports on Jan 2.

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GenesWell ddEGFR Mutation Test of Gencurix. Gencurix (KONEX: 229000) announced that the nucleic acid quality index (iQC index), allowing the measurement of the quality of the nucleic acid in molecular diagnosis is published in the Journal of Scientific Reports. The article suggests that the quality of nucleic acid is very important in order to obtain accurate test results with nucleic acid based molecular diagnostics, and the minimum quality of the nucleic acid that can be tolerated for diagnosis. The GenesWell (TM) ddEGFR Mutation Test exhibited superior performance to the competitor's kit. GenesWell ddEGFR Mutation Test of Gencurix with completion of approval (class 3) by the Ministry of Food & Drug Safety (MFDS) 2017 September is expected provide more accurate and suitable treatment to patients by overcoming the shortcoming of the diagnostic test using FFPET. (Photo: Business Wire)

The nucleic acid quality index (iQC index) is the joint study with the “Companion Diagnostics center of LOGONE Bio Convergence Research Foundation,” which is a nonprofit public interest research foundation established on the premise of the Center for Anti-Cancer Companion Diagnostics.

With the arrival of the era of individual precision medicine, the diagnosis using nucleic acid (DNA, RNA) is used as an important tool for precision medicine and the analysis for the cancer related genes in diagnosis has become a very important factor for appropriate treatment.

Patient tissues for diagnosis are stored in Formalin-fixed paraffin-embedded (FFPE) tissue specimens for the convenience of specimen storage. However, FFPE fixation procedure and storage condition causes several kinds of damage to nucleic acids, creating challenges to molecular analyses using FFPE-derived nucleic acids (DNA, RNA). For example, presence of T790M of EGFR which is known to be responsible for 1^st or 2^nd EGFR-TKI resistance is a prediction of resistance shown by NSCLC patients. If T790M of EGFR in FFPE DNA is interpreted as false positive by sequence artifact, it limits the treatment options. In other words, it is very important to eliminate false positives for accurate diagnosis and to reflect the quality of nucleic acids used for analysis in diagnosis.

This article describes the establishment of the criterion of exclusive nucleic acid quality (iQC index) for accurate diagnosis and verification of the clinical utility of iQC index through clinical trials. Through the multi-center retrospective clinical trials, they observed that the degree of nucleic acid damage was different according to the storage duration, sample process and condition of FFPET collected from various hospitals. Also they confirmed that these factors have a major impact on diagnosis through comparative clinical trials with already approved companion diagnostics kit. Based on these facts, they established the exclusive criterion (iQC index) of GenesWell™ ddEGFR Mutation Test to reflect the degree of nucleic acid damage in the diagnosis. In the case of competitor kit, the frequency of false negatives appeared high in the samples below the value of the iQC index, but the GenesWell™ ddEGFR Mutation Test is accurate and consistent regardless of the iQC index. The GenesWell ™ ddEGFR Mutation Test proved that mutation frequency (Mutation index) can be accurately calculated because it can measure absolute amount of wild type and mutant type.

This article suggests that the quality of nucleic acid is very important in order to obtain accurate test results with nucleic acid based molecular diagnostics, and the minimum quality of the nucleic acid that can be tolerated for diagnosis. In addition, the GenesWell ™ ddEGFR Mutation Test exhibited superior performance to the competitor’s kit.

GenesWell ddEGFR Mutation Test of Gencurix Co. Ltd. with completion of approval (class 3) by the Ministry of Food & Drug Safety (MFDS) last September is expected provide more accurate and suitable treatment to patients by overcoming the shortcoming of the diagnostic test using FFPET. It prevents inaccurate diagnosis results through the application of the iQC index that allows representing sample quality as an important criterion for diagnosis.

Approximately 30,000 lung cancer patients occur annually in South Korea, of which non-small cell lung cancer accounts for approximately 80%. The companion diagnosis technology of Gencurix Co. Ltd. is expected to give doctors better options of effective targeted therapy for many lung cancer patients.

Sang Rae Cho, CEO of Gencurix Co. Ltd., said “Development of more accurate companion diagnostics technology with application of the nucleic acid quality index (iQC index) can support personalized treatment with focus on patients and payers of medical expenses will allow not only improve patients’ life quality but also contribute to the integrity of national insurance finance”, and “We will challenge not only the domestic market but also the global market with a differentiated and competitive product.”

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