Multiplex Solution for Better Health

Transcription

1 Multiplex Solution for Better Health

2 About Us About Us Core Technology Technology s Precision Image Code () MicroDisc is manufactured by using a photo lithography fabrication process. This semi-conductor process can generate up to 16,000 distinct circular image patterns of MicroDisc for multiplexing applications. To be used in biological applications, each circular microdisc is encapsulated in a highly stable polymer with an added paramagnetic property, which allows it to be suitable for bio-conjugation, washing, and automation applications. Typical concept of detection by using MicroDisc Jiangsu, Taipei Co., Ltd. was established in May 2010 to design, develop and manufacture IVD products and instrumentations in ISO-certified facilities. To this date, has expanded from Asia headquarters in Taipei, Taiwan to Jiangsu Province, China, and has a U.S research facility in San Francisco. Each MicroDisc has a distinct circular image pattern,which corresponds to the specific capture agents conjugated to the disc surface, thus allowing the capture and detection of specific analytes from a sample. Virtually any probe used in clinical diagnostics can be conjugated to MicroDisc, including DNA, RNA. antigens, antibodies, and other proteins. Molecular Assay (Biotionylated Amplicon) Our Microdisc technology is currently the largest multiplexing platform, capable of generating approximately 16,000 circular image patterns. Each image pattern corresponds to an individual target and can be detected simultaneously via advanced optical imaging and fluorescence analyzers. By using our multiplexing platform, we are able to offer highly sensitive and specific results with low sample volumes, which saves time and labor. Currently, is researching and developing high-quality reagents focusing on companion diagnostics, early cancer detection and prenatal diagnostics with ultra-detection sensitivity and fully automated diagnostics instruments for high-throughput clinical needs. With our innovative technologies, intends to revolutionize the IVD industry developments, placing as the leading brand of global IVD market. 2 Hybridization Immunossay In order to address the issue of rising healthcare costs and an increasing range of available tests, it is crucial for clinical and research labs to consider the cost of labor, sample volume, time and maintenance when it comes to assay formats. Therefore, aims to provide a cutting-edge multiplexing platform using our patented Precision Image Code () MicroDisc technology to overcome this limitation. Advantages : Largest multiplexing platform- generating up to 16, 000 distinct image patterns! Perform both molecular and immunoassay! No fluorescent interference! Time and Cost Effective! s IntelliPlex multiplexing platform is based on the MicroDisc, which is generated via high-tech semi-conductor technology. Antibody- Antibody In order to perform a biological test, MicroDiscs with distinct circular image pattern were pooled together in a single well and reacted with patient sample, followed by hybridization and fluorescent labeling. The assay detection was done by optical imaging florescence analyzer 100, which uses the CCD camera to read the distinct image patterns under bright field and quantifies the analyte by reading the fluorescence signal intensity under dark field, reporting the reactions occurring at each Precision Image () MicroDisc in a user-friendly format. 3

3 Multiplex Multiplex Platform Platform Multiplex Instrumentation: Compact Solution In addition to the general equipment necessary for the handling of reagents, has developed a one-stop free-standing total automation system designed to facilitate clinical use and reduce labor and assay time. DNA/RNA Amplification Multiplex Instrumentation: Automated Solution IntelliPlex 5000 A powerful multiplexing platform based on MicroDisc that automates the entire testing workflow for molecular and immunoassays. IntelliPlex 5000 includes robotic performing of the tests, analyzing the results,and storing the data. Benefits Fully automated platform for improved workflow and better efficiency Higher multiplexing capacity for screening Decreased turn-around time and less human error Programmable temperature and time Real-time display of current temperature Pre-set with PCR programs for assays High throughput Multiplex technology Fully automated Precise identification Dexipher software Hybridization Detection Designed for both molecular and immunoassays Ideal for mixing, incubating discs and targets Adjustable speed and temperature Automated Washing Easy to maintain, no waste or wash fluids High decoding speed No risk of crossover or contamination Combines aspiration, buffer dispensing, shaking-incubation, automatic rinsing, and fluorescence labeling Incoporates a magnetic plate for reducing discs loss Includes a 7-inch touch screen panel 4 5

4 Multiplexing Bioassay Multiplexing Bioassay IntelliPlex Products Companion Diagnostics (CDx) With the rise of interests in personalized medicine, the development and applications of IVD reagents have been increasing as well. In the field of personalized medicine, companion diagnostics is often used for selecting appropriate and optimal therapies based on the content of a patient s genetic makeup. CDx tests are intended to help select and monitor treatments by choosing the right drug for the right person. Overall, in response to individual patient differences, physicians use companion diagnostics as a guide for treatment and have set a trend for future IVD development. However, the mainstream companion diagnostics products in the market today still focus on single gene diagnostics. In light of this, s multiplex technology can simultaneously provide multiple results in a single reaction, offering effective, rapid and diverse clinical diagnostic information for better treatments for patients. This not only reduces healthcare costs, but also brings new opportunities for personalized medicine. BRAF KRAS IntelliPlex KRAS G12/13 Mutation Kit (12 mutations) IntelliPlex BRAF V600 Mutation Kit (7 mutations) IntelliPlex EGFR Mutation Kit (40 mutations) IntelliPlex KRAS Mutation Plus Kit (25 mutations) IntelliPlex ALK Rearrangement Kit (24 variants) IntelliPlex ROS1 Rearrangement Kit (14 variants) IntelliPlex RET/NTRK1 Rearrangement Kit (14 variants) IntelliPlex HCV Genotyping Kit (Genotypes 2,3,4,5,6 and subtypes 1a&1b) Prenatal Diagnostics TORCH+Kit Target Diseases: Toxoplasmosis, Rubella, Cytomegalovirus, herpes simplex virus I & II and human parvovirus B19. EGFR Prenatal diagnostics has been a rapid development area in the recent years, with its main applications focusing on women in their early pregnancies, to identify the risk of fetal anomalies and the health of the mother as well. The prenatal diagnostics market is estimated to have been worth 175 million USD in 2011, and is expected to grow to 200 million USD by In order to meet the market demand and achieve the purpose of woman/baby health care, is focused on the prenatal diagnostics for congenital infections like TORCH+, and Pre-eclampsia diagnostic reagents. Pre-eclampsia Kit Biomarkers: PAPP-A, α-fetoprotein (AFP), PP13, sflt-1, and Soluble Endoglin (seng) all test in one single well. Early Detection According to statistics, cancer incidence and mortality rates continue to increase worldwide, with more than half of the cases occurring in less developed regions. Detecting cancer early, before it becomes malignant or metastasized, remains the best strategy for reducing cancer deaths. The implementation of early detection could potentially save ~3.5 million lives every year, and the use of an accurate and efficient screening tool is more critical than ever before. As a result, has dedicated itself to the development of the non-invasive colorectal cancer screening tool and the HPV genotyping products using innovative technologies. Colon Cancer Colon Cancer Detected Early Intelliplex ColoScape Stool DNA Test : 4 Genes / 15 Mutations Non - Invasive High Accuracy Cost Effective DID YOU KNOW? Survival Rate Detected Late 74% 6% Source : American Cancer Society Current Method of Detection Fecal blood tests: High False Positive/Negative Colonoscopies: Invasive, High Risk, High Cost Market Needs High Accuracy Non-Invasive Low Cost Cervical Cancer Cervical Cancer 16 Detected Early Current Method of Detection PCR, Real-Time PCR Limitations: Low throughput, Low sensitivity Market Needs HPV Genotyping Can detect 14 high-risk genotypes in one single well bdna HPV Genotyping Can detect 14 high-risk genotypes in one well No PCR procedure needed Direct detection of oncogenic E6/E7 mrna Higher Multiplexing Capability Genotyping of Potential High Risk Cost Effective 31 Detected Late 93% 15% Source : American Cancer Society

5 Partner With Us IVD Distributor Together increase the awareness of IVD products and expand the market in your local area and internationally. IntelliPlex Licensing Together expedite your projects in diagnostics infectious research, and more. Customized Service Together provide solutions tailor-made for your demand and needs, including ODM, OEM, and partnership with pharma for CDx. LDT/RUO Together develop solutions for immunodiagnostics, molecular diagnostics, reference laboratories, institution laboratories, and more. Co., Ltd. 6F-1, No. 351 Yangguang Street, Neihu District, Taipei City 114, Taiwan, R.O.C Tel: Fax: Jiangsu Medical Technology Co., Ltd. No. 9, Long Yang Road, Building C2, Science and Technology Industrial Park West Taihu, Wujin District, Changzhou City, Jiangsu Province, China Tel: Fax: Website: