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F-1 We are responsible for the information contained in this prospectus. We have not authorized anyone to provide you with different information, and we take no responsibility for any other information others may give you. We califotnia3749 not, and the underwriters are not, making an offer to sell these securities in any jurisdiction where the offer or sale is not permitted.
Food and Drug Administration FDAhe led a team of staff in pre-market reviews and post-market compliance of one of the first kind of IVD products and LDT services for genetic testing, molecular cancer diagnostics, companion diagnostics, radio dosimetry, digital pathology and artificial intelligence devices. We are not, and the underwriters are not, making an offer to sell these securities in any jurisdiction where the offer or sale is not permitted. We also stay at the forefront of targeted drug development by partnering with global biopharmaceutical companies and research institutions to evaluate personalls and facilitate clinical trials.
Our products and services are appealing to biopharmaceutical companies since we are able to provide customized services and products to suit their different needs, including biomarker evaluation for molecularly targeted therapy and immuno-therapy, clinical trial enrollment, companion diagnostics development and t marketing post-drug approval.
During his tenure of over ten years at the U. Table of Contents Development Services No. With Mutation CapsuleTM technology, a sample collected in one study could be used to test new biomarkers in multiple different studies retrospectively, facilitating efficient product iteration.
The parallel profiling of genetic and epigenetic alterations in a single reaction enable screening for multiple tumor types while minimizing the requirement for blood samples to acquire ctDNA. You should rely only on the information contained in this prospectus or in any related free-writing prospectus. You should not assume that the information contained in this prospectus is accurate as of any date other than its date.
We have also established a clinical development team consisting of 20 members who have completed over 76, validation tests and approximately 17, tests in five clinical trials at 21 GCP sites. Table of Contents Until July 13, the 25th day after the date of this prospectusall dealers that buy, sell or trade s, whether or not participating in this perwonals, may be required to deliver a prospectus.
As of the date california37499 this prospectus, we have collaborated with 26 biopharmaceutical companies, which makes us No. This is in addition to the obligation of dealers to deliver a prospectus when acting as underwriters and with respect to their unsold allotments or subscriptions. Hu brings over two decades of experience in regulatory and managerial capacities related to medical devices and pharmaceutical industries to our team.
Regulatory Approval As it is practiced today in China, cancer diagnosis and treatments are dominantly performed in public hospitals. Our t project with several leading medical institutions was selected to participate in China National Key Research and Development Project led by China National Center for Biotechnology Development, an organization under the MOST, to support development and evaluation of liquid biopsy technology for early screening in lung cancer and digestive system cancers.
We believe advancing our services and products can expand the scope of precision oncology medicine to peesonals, early screening, monitoring and continuous care, improve clinical outcomes and reduce overall cancer treatment costs. OVERVIEW We are a leading precision oncology platform california3749 adult personals in China that specializes in cancer molecular profiling and harnesses advanced technologies in molecular biology and data science to transform cancer treatment.
We have developed a comprehensive product and service portfolio that cover the full-cycle of cancer care from early screening, to diagnosis and treatment recommendations, pefsonals continuous monitoring and continuous care. We believe our collaboration with biopharmaceutical companies will also build evidence of clinical utility for our platform as an effective diagnostic for advanced cancer therapies. Specifically, we are responsible for the identification and development of biomarkers for early liver cancer detection and validate liver cancer early screening assay products.
One of the key benefits of ing such project is that our liver cancer early screening assay products validated in this project will enter fast-track review process by NMPA.
The unmet medical needs of the large cancer population in China present ificant market opportunities for precision oncology, especially cancer molecular afult. With a reverse transcription and two PCR reactions, the FusionScan technology can efficiently detect translocations with high sensitivity and low cost.
We plan to further validate the early screening models by conducting research and data accumulation on over 50, cohort for each cancer types in selected regions in China and apply for NMPA IVD registration post-validation. The information contained in this prospectus is current only as of the date of this prospectus, regardless of the time of delivery of this prospectus or of any sale of the s.
We have not authorized anyone to provide you with different information, and we take no responsibility for any other information others may give you. Further, our robust commercial adoption capability is able to contribute ificantly on t marketing and promotion efforts post-drug approval. Our regulatory capabilities are highlighted by our strong regulatory team, robust pipeline of IVD products and high-quality clinical laboratory services.
california7349 We have not authorized anyone to provide you with information different from that contained in this prospectus. We enhanced Genetron Asult SeqTM Method to be suitable for liquid biopsy, which is able to detect rare molecule in liquid biopsy with high sensitivity up to 0. Therefore, accessibility to public hospitals is critical for companies specializing in precision oncology.
Beijing Consensus on NGS Technology represents the first authoritative consensus on the standardized application of NGS technology in oncological clinical practice within China.
We expect to complete the follow up of the 2,case prospective cohort by end of Persons outside the United States who come into possession califfornia3749 this prospectus must inform themselves about and observe any restrictions relating to the offering of the s and the distribution of the prospectus outside the United States. Our platform cultivates a network nationwide that connects a patient with third-party healthcare service providers, including hospitals, medical examination centers, and insurance companies.
We are offering to sell, and seeking offers to buy, the s only in jurisdictions where offers and sales are permitted. We are also a pioneer in the diagnosis and monitoring of thyroid, upper tract urothelial and bladder cancers. We strongly believe that a fully-integrated and best-in-class precision oncology platform is key to our business and will be the engine that drives our future success and solidifies our market leading position in the highly competitive precision oncology industry in China.
qdult We are at the forefront of the development of liver cancer early screening products. We have not taken any action to permit a public offering of the s outside the United States or to permit the possession or distribution of this prospectus outside the United States. There is a critical need to offer a comprehensive profiling solution and expand the scope of precision oncology to enable early screening, diagnosis, continuous monitoring and continuous care.
Our unique mix of industry leading cancer research capabilities, comprehensive products and services, and focused commercialization strategies have led to our success in building competitive advantages. Adoption by public hospitals and insurance coverage often requires registration from the NMPA or approval from competent regulatory authorities.
This is a critical benefit for ctDNA-based liquid biopsy because the limited ctDNA yield of the testing sample is one of the primary impediments of ctDNA-based liquid biopsy, and any loss of original ctDNA would decrease the sensitivity.
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