Medical Products Supplies Companies

54, Techno 10-ro, Yuseong-gu, 34027 Daejeon
Korea, Republic
Telephone +82 10 3422 9150
Fax +82 42 861 9297
seewook.kim@panagene.com
http://www.panagene.com

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Product categories

03 Diagnostic Tests
03.06 Genetic testing, molecular diagnostics
03.06.04 Other molecular diagnostics testing

Other molecular diagnostics testing

Our products

Product category: Other molecular diagnostics testing
[Oncology – Liquid biopsy] PANAMutyper™ R EGFR
Lung cancer is a metastatic cancer which the cancer cells are developed in the bronchial tubes or alveoli and grow along the blood vessel or lymphatic vessel. There are two types of lung cancer based on the sizes and shape of the cancer cell; non-small cell lung cancer (NSCLC) takes 75% and small cell lung cancer takes 25%. Usually, it is hard to find lung cancer in the early stage and is diagnosed as lung cancer when it is already progressed. So the prognosis tends to be bad. It is known that the patients with EGFR mutation show very high drug responses against EGFR tyrosine kinase inhibitor (TKI) such as Gefitinib (Iressa, AstraZenca) and Erlotinib (Tarceba, Roche). We expect that genotyping EGFR genes of the lung cancer patients enables predicting drug response before treatment and this will lead effective lung cancer treatment.

Product category: Other molecular diagnostics testing
[Oncology – Liquid biopsy] PANAMutyper™ R KRAS
KRAS mutation is found in several cancers such as pancreatic cancer, colorectal cancer, lung cancer, biliary tract cancer and thyroid cancer. The existence of KRAS mutations is often related with a prognostic marker to drug response. For example, KRAS mutation is considered a strong prognostic marker for drug response of tyrosine kinase inhibitors such as Gefitinib (Iressa) or Erlotinib (Tarceva). Recently, KRAS mutation is often detected in colorectal cancer and may be related with drug response to Cetuximab (Erbitux) or Panitumumab (Vectibix) that is used for colon cancer therapy. Therefore, examination of KRAS mutation is needed to determine drug resistance of patients with colorectal or lung cancers and will be helpful for cancer therapies.

Product category: Other molecular diagnostics testing
[Oncology – Liquid biopsy] PANAMutyper™ R NRAS
NRAS mutation is found in several cancers such as melanoma (13~25%), colorectal cancer (1~6%), lung cancer (1%), thyroid cancer (7%) and hepatocellular carcinoma (10%). It is know that the drug response against colorectal cancer medicine such as Erbitux and Cetuximab decreased and the prognosis of the metastatic colorectal cancer patient is bad if the patient has NRAS mutation. Recently, there are some papers that report the drug responses can be different for the NRAS mutation type so it is important to genotype each mutation. NRAS gene mutation genotyping test is necessary especially for predicting the drug sensitivity and prognosis. This test expected to play a major role for predicting the treatment of the patients and prognosis.

Product category: Other molecular diagnostics testing
[Oncology – Liquid biopsy] PANAMutyper™ Screening Kit ROS1
PANAMutyper™ ROS1 Screening Kit is the qualitative diagnostic test kit which is able to detect 20 different ROS1 fusion genes of formalin-fixed paraffin-embedded (FFPE) tissue, fresh tissues and biopsy tissues from non-small cell lung cancer (NSCLC) patients using peptide nucleic acid (PNA) probes in a real-time PCR system.

The PANAMutyper™ ROS1 Screening Kit is intended as an aid for screening ROS1 fusion-positive NSCLC patients who would be sensitive for receiving ROS1 inhibitor therapy such as crizotinib, Lorlatinib, etc.

Product category: Other molecular diagnostics testing
[Oncology – Liquid biopsy] PANAMutyper™ Screening Kit EML4-ALK
PANAMutyper™ EML4-ALK Screening Kit is the qualitative diagnostic test kit which is able to detect 16 different EML4-ALK fusion genes of tissue from non-small cell lung cancer (NSCLC) patients using peptide nucleic acid (PNA) probes in a real-time PCR system. The PANAMutyper™ EML4-ALK Screening Kit is intended as an aid for screening EML4-ALK fusion-positive NSCLC patients who would be sensitive for receiving ALK inhibitor therapy such as crizotinib.

Product category: Other molecular diagnostics testing
[Oncology – Tissue biopsy] PNAClamp™ Mutation Detection Kit EGFR (ver.2)
Lung cancer is categorized into two types; non-small cell lung cancer (NSCLC) with the 80~85% frequency and small cell lung cancer with the 15~20% frequency. Epidermal growth factor receptor (EGFR) is expressed on the surface of epidermal cells and has the tyrosine kinase activity. Overexpression of EGFR is found only in NSCLC and may lead to signal transduction system in cells by causing cell proliferation, tumor-induced neoangiogenesis (formation of new blood vessels) and transition induction. The EGFR tyrosine kinase inhibitor (TKI), gefinitib (Iressa, AstraZenca) or erlotinib (Tarceba, Roche), is effective to inhibit the growth of cancer cells and leads to death of cancer cells and suppression of new blood vessels in lung cancer tissue. Especially, some specific mutations in the ATP-binding domain of EGFR gene have strong positive correlation with the response rate of EGFR-TKIs. Furthermore, NSCLC patients with the EGFR mutations are reported to be more effective to EGFR-TKI and show prolonged survival rate of patients with lung cancer. Therefore, detection of the EGFR mutation is becoming an important prognostic biomarker for drug response, and efficient detection of the EGFR mutation is expected to be highly helpful for increase of survival rate of patients with lung cancer in targeted therapy.

Product category: Other molecular diagnostics testing
[Oncology – Tissue biopsy] PNAClamp™ Mutation Detection Kit KRAS (ver.4)
KRAS mutation is found in several cancers such as colorectal, lung, thyroid, pancreatic, cholangiocarcinoma. The KRAS mutations are often found on codons 12 and 13 of the exon 2, and lead to abnormal change of growth signal of the p21-ras protein. This abnormal change involved with cell growth and division may cause the process of cancer development by delivering the signal in excess. Existence of KRAS mutations is often related with a prognostic marker to drug response. For example, KRAS mutation is considered a strong prognostic marker for drug response of tyrosine kinase inhibitors such as gefitinib (Iressa) or erlotinib (Tarceva). Recently, KRAS mutation is often detected in colorectal cancer and may be related with drug response to cetuximab (Erbitux) or panitumumab (Vectibix) that is used for colon cancer therapy. Therefore, examination of KRAS mutation is needed to determine drug resistance of patients with colorectal or lung cancers and will be helpful for cancer therapies.

Product category: Other molecular diagnostics testing
[Oncology – Tissue biopsy] PNAClamp™ Mutation Detection Kit NRAS
NRAS mutation is found in several cancers such as melanoma (13~25%), colorectal cancer (1~6%), lung cancer (1%), thyroid cancer (7%) and hepatocellular carcinoma (10%). It is know that the drug response against colorectal cancer medicine such as Erbitux and Cetuximab decreased and the prognosis of the metastatic colorectal cancer patient is bad if the patient has NRAS mutation.

Product category: Other molecular diagnostics testing
[Oncology – Tissue biopsy] PNAClamp™ Mutation Detection Kit BRAF
BRAF mutation is found in several cancers including thyroid cancer, malignant melanoma, ovarian cancer, colorectal cancer. In case of thyroid cancer, there are over 40 different types of BRAF mutation. Of these mutations, the V600E mutation on exon 15, i.e. change of nucleotide from T to A in 1799th base that results in change from valine to glutamate in amino acids, is most important with over 90% of frequency. Especially, BRAF V600E mutation is detected with ca. 45% of frequency in papillary thyroid carcinoma and is considered a prognostic maker for thyroid cancer.

Product category: Other molecular diagnostics testing
[Oncology – Tissue biopsy] PNAClamp™ Mutation Detection Kit IDH1
Mutations of IDH1 (isocitrate dehydrogenase 1,IDH1) can be found in glioblastoma and myeloproliferative neoplasm. Detection of IDH1mutations can be a positive predictor of a prognosis and a molecular marker for glioblastoma patients. On the other hand, it is reported that IDH1 mutations correlate with poor prognosis in myeloproliferative neoplasm.
PNAClamp™ IDH1 Mutation Detection Kit is a new member of somatic mutation detection kits utilizing PNA-mediated PCR Clamping technology, and can help patients choose the right medicine and monitor prognosis.

Product category: Other molecular diagnostics testing
[Oncology – Tissue biopsy] PNAClamp™ Mutation Detection Kit IDH2
IDH2 is frequently mutated in glioma, acute myeloid leukemia, and myelodysplastic syndromes. Mutations generally involve point mutations at the R140 and R172 residues of the protein. Mutations in IDH1 and IDH2 result in deleterious “gain of function”: instead of converting isocitrate to α-ketoglutarate, mutated IDH1 or IDH2 converts isocitrate to 2-hydroxyglutarate. 2-hydroxyglutarate inhibits other proteins involved in epigenetic regulation.

Product category: Other molecular diagnostics testing
[Oncology – Tissue biopsy] PNAClamp™ Mutation Detection Kit PIK3CA
PIK3CA mutation activates PI3K (Phosphatidylinositol 3-kinase) protein and PI3K activates several signaling pathways of tyrosine kinase receptors. Activated tyrosine kinase represses the function and excitometabolism of protein which inhibits cell survival and division. These abnormal changes initiate the process of cancer development by activating the protein involved in cell growth. Point mutations in PIK3CA are detected with ca. 80% of frequency in exon 9 (interpreted as helical part of PI3K protein) and exon 20 (interpreted as kinase part), while other types of mutations are also seen in many different locations. PIK3CA mutations are found with 25 to 40 % frequency in various types of cancer like colorectal cancer, gastric cancer, lung cancer, brain cancer, endometrial cancer, ovarian cancer, breast cancer, and more.

PNAClamp™ PIK3CA Mutation Detection Kit utilizes modified PCR technology, using optimized PNA probes that tightly bind to wild type DNA templates. This tight binding to the wild type DNA templates result in no amplification of the wild type DNA template in PCR reaction while the mutated genes, especially with SNPs, PCR amplification is processed for multiplication of the mutated DNA sequences.

Product category: Other molecular diagnostics testing
[Oncology – Tissue biopsy] PNAClamp™ Mutation Detection Kit BCR-ABL
CML (Chronic myelogenous leukemia) patients who has consistently treated with Imatinib (Gleevec), have acquired point mutations in tyrosine kinase domain of BCR-ABL fusion gene. Especially, T315I mutation is known as a mutation associated with Imatinibresistance and observed with high frequency.
It is important to monitor patients treated with Imatinibby BCR-ABLfusion gene mutation test to prevent therapy failure due to drug resistance by mutation.

Product category: Other molecular diagnostics testing
[Oncology – Tissue biopsy] PNAClamp™ Mutation Detection Kit JAK2
JAK2 V617F mutation is found in patients with blood related disease such as Polycythemia Vera, Essential Thrombocythemia and Myelofibrosis. Ruxolitinib is effective as a JAK Inhibitor, so that it is a prognostic factor to determine drug response.
JAK2 V617F mutation detection makes easy to classify patients with MPD (Myeloproliferative Disease) as three levels of diagnostic certainty (possible, probable and definite) and to determine which signal transduction therapy is suitable for each patients. In addition, testing for JAK2 V617F mutation has been recommended as clinical tests by WHO(World Health Organization).

Product category: Other molecular diagnostics testing
[Oncology – Tissue biopsy] PNAClamp™ Mutation Detection Kit c-KIT
C-kit (also called CD117) may also be found in higher than normal amounts, or in a changed form, on some types of cancer cells, including gastrointestinal stromal tumors and melanoma. Measuring the amount of c-kit in tumor tissue may help diagnose cancer and plan treatment. C-kit is a type of receptor tyrosine kinase and a type of tumor marker.

Product category: Other molecular diagnostics testing
[Oncology – Tissue biopsy] PNAClamp™ Mutation Detection Kit TERT
The presence of TERT mutation is a prognostic and predictive biomarker in patients with cancer such as the central nervous system, bladder, thyroid, skin, etc., associated with tumor recurrence and survival.

With its features of detection limit as low as 5% copies/rxn, the PNAClamp™ TERT Mutation Detection Kit is the qualitative diagnostic test kit which is able to detect 2 different types of TERT promoter mutations of formalin-fixed paraffin-embedded (FFPE) tissue, fresh tissues and biopsy tissues using peptide nucleic acid (PNA)-mediated real-time PCR clamping technology.

Product category: Other molecular diagnostics testing
[Infectious Diseases] PANA RealTyper™ HPV
According to the WHO report (2008), human papillomavirus (HPV) causes virtually 100% of cases of cervical cancers. There are more than 100 genotypes of HPV reported currently, and HPV consists of double helix circular DNA with ca. 7,900 bps. Compared to the traditional Pap smear test, HPV genotyping has several advantages; 1) high accuracy of determining existence of HPV viruses, 2) genotyping of the HPV viruses, 3) early diagnosis, 4) identifying patients harboring HPV with high risk type, and 5) contribution to prevention and therapy of cervical cancers in the end.
PANA RealTyper™ HPV kit is an in vitro diagnostic reagent for genotyping of human papilloma virus (HPV) using peptide nucleic acid (PNA) probes. This kit is an amplified DNA test for the qualitative detection of a total of 40 HPV genotypes in a real-time PCR (polymerase chain reaction) system. This kit provides genotyping information of 20 high-risk and 2 low-risk types using melting temperature (Tm) analysis. Furthermore, this kit also detects 18 other genotypes (without genotyping) in DNA samples from clinical specimens

Product category: Other molecular diagnostics testing
[Infectious Diseases] PANA RealTyper™ Screening Kit HPV (screening)
HPV is well-known as as major cause of cervical cancer. More than 40 pathogens in 100 kinds of HPV has been found in female genital organ. The High-Risk group of those viruses is generally known for a direct correlation with cervical cancer. That is why WHO highly recommend the HPV DNA test.
PANA RealTyper™ HPV Kit can detect 14 pathogens of High risk group and 2 pathogens of Low risk group. With the Real-time PCR technology, it can quickly and accurately show the test results about whether patients have those pathogens or not, and also it can be used as a screening test.

Product category: Other molecular diagnostics testing
[Infectious Diseases] PANA RealTyper™ Kit STD
STD(Sexually Transmitted Disease) can be diagnosed by using DNA extracted from vaginal swabs or urine of patients suspected of having STD.
PANA RealTyper™ STD Kit is able to accurately detect the presence or absence of 13 STIs (Sexually Transmitted Infections) and distinguish each infection type by Multiplex Real-Time PCR using unique Tm of each PNA fluorescent probe.

Product category: Other molecular diagnostics testing
[Infectious Diseases] PANA RealTyper™ CRE
Carbapenem-resistant Enterobacteriaceae (CRE) is Gram-negative bacterium that is resistant to the carbapenem class of antibiotics, considered the drugs of last resort for such infections. Rapid and accurate CRE detection/identification testing is important for proper antibiotic prescription and rapid treatment.PANA RealTyper™ CRE Kit can accurately detect and genotype 6 types of CRE in a short time (within 3 hours).

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About Us

Company details
We will always make our best efforts to develop innovative platform technologies and to be a global leader in the field of molecular diagnostics.
PANAGENE have been supplying Peptide Nucleic Acid (PNA) worldwide and exclusively since 2006 based on our unique invention of efficient synthesis of PNA with high purity, and nowadays we are possessing the best knowledge on PNA and the largest number of patents on the PNA and its applications in the world.

PNA, an artificial genetic material (a DNA mimic) invented at early 1990s, has been drawn much attention of researchers as a promising material candidate for especially diagnostic and therapeutic use, due to its advanced physicochemical properties such as strong binding affinity with complementary nucleic acids and superior biological/chemical stability.

Based on the advantage of PNA material and our accumulated knowledge, we have developed various innovative platform technologies on molecular diagnostics covering multiplexing, mutated gene specific amplification, SNP discrimination and so on. To meet rapidly changing diagnostic market needs, our efforts for innovation will continue.
PANAGENE has expertise especially in cancer-related molecular diagnostics including companion diagnostics using tissue or liquid biopsy specimens. Our advanced technology provides not only high level of detection but also simple and convenient procedure to be used easily in the front-line hospitals and clinical laboratories by themselves.

We have been developing and launching accurate and convenient in vitro diagnostic products consistently. We exercise strict quality management policy and make efforts to meet global standards and appropriate regulations for our IVD products. We believe that results of our efforts to produce IVD products will greatly contribute for helping human healthcare in the future.
PANAGENE is pursuing open innovation and seeking opportunity for collaboration with various organizations including pharmaceutical and diagnostic companies. We always welcome contacts of organizations who are interest in our technologies and/or products.

We will do our best for customer satisfaction and for realizing our vision, “Platform Technology Provider”, we promise.

Please keep an eye on PANAGENE becoming a world leader in molecular diagnostics.

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