POLE

SEOUL, South Korea, June 13, 2023 /PRNewswire/ -- Gencurix, a leading cancer molecular diagnostics company, has obtained approval from the Korean Ministry of Food and Drug Safety for its Droplex EGFR Mutation Test v2. This product is a companion diagnostic test designed to detect EGFR mutations commonly found in NSCLC patients and guide the selection of appropriate targeted anticancer therapies based on the test results. It is an IVD product that can be used with Bio-Rad's Droplet Digital PCR instrument and has also obtained CE certification in Europe last year. Compared to existing EGFR mutation tests using RT-PCR, this product demonstrates significantly higher sensitivity. This makes it capable of accurately detecting mutations even when plasma samples are used as the specimen. Additionally, while most existing products detect fewer than 50 mutations, this test can detect up to 107 mutations, further enhancing its accuracy. Notably, this product has an additional strength in its ability to detect Exon 20 Insertion, a mutation that has recently garnered significant attention in the oncologist community following the launches of Janssen's Rybrevant and Takeda's Exkivity. Among the existing single gene tests, there were no tests available to properly detect this mutation, necessitating the use of costly and time-consuming NGS tests. This is the second EGFR mutation test for which Gencurix has obtained approval. In addition, Gencurix has obtained European CE registration for a total of nine products, including KRAS, BRAF, C-MET, PIK3CA, ESR1, and POLE tests, making it the company with the highest number of digital PCR-based IVD tests in its portfolio. Hyun Park, VP of Strategy & Business Development at Gencurix, stated, "Gencurix has been developing diagnostic products that utilize Droplet Digital PCR technology, which has primarily been used for research purposes, in the field of cancer diagnostics. Through years of research and development, we are proud to have achieved world-class technological capabilities and a product portfolio." Gencurix is also developing solutions for early cancer detection and minimal residual disease (MRD) screening using digital PCR technology. The company also introduced new technology detecting colorectal cancer recurrence at AACR last April. Gencurix has been supplying diagnostic kits to major hospitals in Korea, such as Samsung Medical Center and Yonsei Severance Hospital, and has been actively expanding its global sales network, securing distributorship agreements in Europe, Asia, and other continents. In addition to collaborating with Bio-Rad, a leading manufacturer of digital PCR instruments, on marketing efforts, Gencurix is also pursuing the acquisition of new distributors. About Gencurix: Gencurix is a leading provider of molecular cancer diagnostics, dedicated to developing innovative solutions that improve patient outcomes. Committed to research and development, Gencurix strives to address unmet needs in cancer diagnosis and treatment, ultimately revolutionizing the field of precision medicine. For more information, visit . SOURCE Gencurix

The in-vitro diagnostic (IVD) test, which can be used with Bio-Rad’s Droplet Digital PCR instrument, can detect up to 107 mutations and shows high sensitivity compared to existing EGFR mutation tests using RT-PCR The CDx can be used with Bio-Rad’s Droplet Digital PCR instrument. (Credit: Louis Reed on Unsplash) Gencurix, a cancer molecular diagnostics company, has secured South Korea’s Ministry of Food and Drug Safety approval for its Droplex EGFR Mutation Test v2. Droplex EGFR Mutation Test v2 has been approved as a companion diagnostic (CDx) test to detect EGFR mutations, commonly found in NSCLC patients, for the selection of anticancer therapies. The in-vitro diagnostic (IVD) test can be used with Bio-Rad’s Droplet Digital PCR instrument and can accurately detect mutations even when plasma samples are used as the specimen. It can detect up to 107 mutations, while most existing tests can detect up to 50 mutations, and shows high sensitivity compared to existing EGFR mutation tests using RT-PCR. Also, the test can detect Exon 20 Insertion, a mutation that has recently gathered attention following the launches of Janssen’s Rybrevant and Takeda’s Exkivity. Gencurix strategy and business development VP Hyun Park said: “Gencurix has been developing diagnostic products that utilize Droplet Digital PCR technology, which has primarily been used for research purposes, in the field of cancer diagnostics. “Through years of research and development, we are proud to have achieved world-class technological capabilities and a product portfolio.” Gencurix is a cancer diagnostics provider that has been supplying diagnostic kits to major hospitals in South Korea and is actively expanding in Europe, Asia, and other markets. The Droplex EGFR Mutation Test v2 is the company’s second EGFR mutation test to receive regulatory approval and has been granted the CE mark approval last year. It has obtained CE registration for nine products in its digital PCR-based IVD tests portfolio, including KRAS, BRAF, C-MET, PIK3CA, ESR1, and POLE tests. Gencurix is also developing solutions for early cancer detection and minimal residual disease (MRD) screening using digital PCR technology. In addition to collaboration with digital PCR instruments manufacturer Bio-Rad, the company is also pursuing the acquisition of new distributors.

New research shows that pathogenic polymerase epsilon and delta (POLE/POLD1) genetic mutations lead to improved response to immune checkpoint blockade, a powerful class of immunotherapy drugs. The findings contribute to a growing list of discoveries that prove certain classes of drugs are more effective in cases where the genetic makeup of the tumor -- and not the type or origin of the tumor -- should determine the decision-making process for treatment. New research from Cleveland Clinic is demonstrating that pathogenic polymerase epsilon and delta (POLE/POLD1) genetic mutations lead to improved response to immune checkpoint blockade, a powerful class of immunotherapy drugs. The findings, published in Nature Genetics, contribute to a growing list of discoveries that prove certain classes of drugs are more effective in cases where the genetic makeup of the tumor -- and not the type or origin of the tumor -- should determine the decision-making process for treatment. "To date, this is the most comprehensive analysis of the mutations in POLE/POLD1 genes in patients with cancer," said Timothy Chan, M.D., Ph.D., chair of the Center for Immunotherapy and Precision Immuno-Oncology at Cleveland Clinic. "Our research here shows that patients with POLE/POLD1 mutations should get immune checkpoint blockade therapy as a preferred treatment, and that POLE/POLD1 mutations are a potential indication for immunotherapy regardless of the cancer type or where the cancer started in the body." POLE/POLD1 are DNA repair genes that are genetically altered in nearly 4% of tumors across all cancer types. Not all the POLE/POLD1 mutations are pathogenic (predisposed to a certain disease) or functional that could lead to sensitivity to immunotherapy. Tumors containing pathogenic POLE/POLD1 mutations have high levels of immune cell infiltrations, and until this point, it was challenging to distinguish these pathogenic mutations from non-functional ones. It had remained unclear how these mutations would affect patients' response to anti-tumor immunity therapy. In preclinical models, the growth of tumors introduced with well-established POLE/POLD1 pathogenic mutations was dramatically inhibited by immune checkpoint blockade therapies. In contrast, treatment had little effect on growth of the parental POLE/POLD1 non-mutated tumors. To determine whether similar phenomena could be observed in patients, the team generated statistical learning models based on mutational signatures of the POLE/POLD1 mutant tumors. These signatures could identify the telltale DNA fingerprints of functional POLE/POLD1 mutations. Modeling demonstrated high accuracy for distinguishing the tumors with pathogenic POLE/POLD1 mutations from tumors with the functional mutation. The researchers further found that their model outperformed other traditional approaches for identifying the patients with pathogenic POLE/POLD1 mutations that are more likely to benefit from immunotherapy. It was able to identify mutations that sensitize tumors to immunotherapy that would otherwise have been missed. Further analysis indicated that the underlying mechanism is associated with the increased quantity and quality of the immunogenic mutations, as well as the improved immune microenvironment in the tumors harboring pathogenic POLE/POLD1 mutations. "The short-term impact of this study on cancer immunotherapy is that we demonstrated that tumors with functional POLE/POLD1 mutations are sensitive to immunotherapy," said Xiaoxiao Ma, Ph.D., a postdoctoral researcher at Cleveland Clinic and lead author of the study. "The long-term impact is that we demonstrated it's possible to utilize genomic features, such as mutational signatures, to identify a major indication for immune checkpoint therapy." The study was funded in part by the National Cancer Institute (part of the National Institutes of Health) and Brian and Diana Taussig.