PANAGENE Inc. a genetic molecular diagnostic company, reported that PANA Realtyper™ HPV screening Kit received a medical device item approval from the Ministry of Food and Drug Safety. PANA Realtyper™ HPV screening kit is a medical device for in-vitro diagnostic analysis that is qualitatively detected by real-time PCR. A single test can detect 14 high-risk groups of HPV (Genotyping 16,18 / Screening 31,33,35,39,45,51,52,56,58,59,66,68), two major risk factors for cervical cancer, and 2 low-risk groups (Genotyping 6,11) for vaccine prescription. The need for a first-line primary screening test to identify the risk of cervical cancer is emerging worldwide, and it is expected that the market for HPV screening diagnostics will grow as the existing uterine cell test method is replaced by more accurate and sensitive molecular diagnosis. PANAGENE Inc. PANA Realtyper™ HPV Screening Kit is designed for overseas markets in line with this trend. It is suitable for screening diseases because the HPV kit can easily detect high-risk groups in a single reaction. In the future, Korea is expected to increase the necessity of screening kits that can easily replace the cell test method as the global trend is. However, in consideration of the practical needs of domestic clinical sites, PANAGENE Inc. reported that it was developed to detect low-risk groups, which are currently targeted for cervical cancer vaccine prescription. An official from PANAGENE Inc said, "We plan to expand into overseas market with our HPV screening product, launched together with our STD diagnosis product." Also, "We will do our best to be recognized in the global infectious disease market with PANAGENE’s technology in cancer-related molecular diagnosis."

PANAGENE Inc. launches liquid biopsy test tool, eyes US marketPublished in Nov 8, 2017Korea’s biotech company Panagene said on Nov. 8 it will accelerate its push into the US market with its recently launched blood test tool that detects cancer and determines whether lung cancer patients are likely to respond to drugs.The Daejeon-based company’s liquid biopsy lung cancer diagnosis tool called PANAMutyper R EGFR, introduced in October here, enables the detection of as little as 0.1 percent mutant allele, seeking to replace painful tumor tissue extract test.For the original article, please click the following link.(http://www.theinvestor.co.kr/view.php?ud=20171108000882)- PANAGENE, Inc. -

PANAGENE's Colorectal Cancer-Related Mutation Test Kit, approved for Health Insurance BenefitsPANAGENE, PNA (Peptide Nucleic Acid)-baseddiagnosticscompany,has announced that its'PNAClamp NRAS Mutation Detection Kit', which is used to prescribe a targeted therapy and treatmentfor colorectal cancer patients,was approved as a productcovered by health insurance benefits. The health insurance benefits using PNAClamp NRAS Mutation Detection Kitwill be applied from October.The PNAClamp™ NRAS Mutation Detection Kit (PNA) is a mutation test product that can helpdecide on targeted therapyfor colon cancer, such as Merck's Erbitux, and it is expected that many colon cancer patients can benefit through this approval.For the original article, please click the following link.http://news.mk.co.kr/newsRead.php?year=2017&no=645071- PANAGENE, Inc. -

PANAGENE, World's First Development of Thyroid Cancer Related Gene Diagnosis kitPANAGENE Inc., a company that specializes in gene diagnosis based onPNA (Peptide Nucleic Acid; an artificial nucleotide), announced on July 7 that it has succeeded in developing Telomerase reverse transcriptase promoter (TERT) and Iran TERT mutation diagnostic kit using PNA.TERT is the most accurate indicator of the risk of recurrence of papillary thyroid cancer in the US Thyroid Society in 2015. Since then, studies that predict the prognosis and the risk of metastasis in some brain tumor patients, as well as thyroid cancer, have become one of the most important genes worldwide.However, due to the inherent characteristics of TERT, it was difficult to apply it to actual clinical field.The DNA mutation test using the DNA amplification method called PCR (Polymerase Chain Reaction) is used for the mutation test. However, since the TERT mutation test results in a drop in the PCR efficiency due to the base sequence characteristic of TERT alone, The biggest problem was that there were many cases that could not be done.PANAGENE has developed a diagnostic kit that overcomes these problems using the proprietary features and advantagesofPNA, and its proprietary PNAClamp ™ platform technology. The PANAGENE product is the world's first TERT diagnostic kit using real-time PCR."We will begin the process of registering a food and drug safety office so that the TERT diagnostic kit can be used in the medical field in a short period of time." said.For the original article, please click the following link.http://news.mk.co.kr/newsRead.php?year=2017&no=600385- PANAGENE, Inc. -