Event
On July 23, 2018, the Food and Drug Administration (CFDA) released the "Notice of Release of Permitted Production Approvals on July 23, 2018". Among them, "Human EGFR/ALK/BRAF/KRAS Gene Mutation Combined Detection Kit (Reversible End Termination Sequencing Method)" applied by Guangzhou Burning Stone Medical Laboratory Co., Ltd. has obtained the approval for production, which will be the first NGS tumor multi-gene detection kit approved by CFDA in China.
Comments
First NGS tumor companion diagnostic approved: The kit is China's first combined multi-gene tumor mutation detection kit based on high-throughput sequencing (NGS) and companion diagnostic standards, and it will be used to help patients with non-small cell lung cancer (NLC) to accurately select targeted drug treatments. patients to accurately select targeted drug therapy.
Concomitant diagnostic products have a higher reporting threshold than general in vitro diagnostic products, and in September 2016, the Drug Administration approved the kit as China's first tumor NGS test product to enter the "Innovative Medical Device Special Approval Procedure," after clinical sample validation and review of the registration and manufacturing quality system. In September 2016, the Drug Administration approved the kit as China's first tumor NGS test product to enter the "Innovative Medical Device Special Approval Process", and after clinical sample validation and review of the registered production quality system, the kit successfully obtained the first tumor NGS certificate, which took nearly 2 years.
In addition to Ignite Medical, Domestic enterprises engaged in the declaration of oncology NGS products, there are a number of companies such as Aide et al Biologique, UW Genetics , such as Aide et al Biologique's human BRCA1 gene and BRCA2 gene mutation detection kit (reversible end termination sequencing method), human cancer multi-gene mutation joint detection kit (reversible end termination sequencing method), human cancer multi-gene mutation joint detection kit (reversible end termination sequencing method), human cancer multi-gene mutation joint detection kit, and so on. For example, Aide Bio's human BRCA1 gene and BRCA2 gene mutation detection kit (reversible end termination sequencing method), human cancer mutation detection kit (reversible end termination sequencing method); UWM's EGFR/KRAS/ALK gene mutation detection kit (combined probe-anchored polymerization sequencing method), BRCA1/2 gene mutation detection kit (combined probe-anchored polymerization sequencing method), and so on. A number of tumor sequencing related products have successfully entered the special approval for innovative medical devices.
The US FDA has approved a number of NGS-based companion diagnostic products (e.g. Foundation Medicine's FoundationFocus CDx BRCA, and Thermo Fisher's Oncomine DX Target Test), and the country is also converging with the international standard in the regulatory approval of related products.
Previously, similar products with certificates of registration in China were based on the PCR (molecular amplification) platform, which was rapidly gaining popularity due to its low price and simple methodology that was easy to perform in hospitals. However, second-generation sequencing has far better coverage, detection throughput and sensitivity than other methods. Patients only need to undergo one test to simultaneously understand the hotspot and non-hotspot mutation panorama of multiple tumor treatment-related genes, as well as encompassing a variety of mutation forms such as point mutation, insertion deletion, rearrangement (fusion) and other mutation forms, so as to provide one-stop testing solutions for doctors and patients of multiple targeted drugs, saving testing samples and testing time. time for testing. The approval of this product means that NGS has made the leap from LDT (Laboratory Developed Test) to IVD (In Vitro Diagnostic Valve) in the field of tumor diagnostics, and can be formally applied to hospitals or third-party testing laboratories with NGS's testing capabilities and qualifications, which is a landmark significance.
The application of NGS will also open up new market space for precision tumor diagnostics: From the pricing point of view, NGS sequencing, due to its technical superiority and complexity, is priced at a much higher charge than PCR platform products, and thus the popularity of NGS tumor precision products is conducive to improving the overall market size, similar to the development of in vitro diagnostics history, the chemiluminescence immunoassay (as opposed to chemiluminescence immunoassay) is a new technology. The popularity of NGS oncology precision products will increase the overall market size, similar to the increase of chemiluminescence immunization (versus enzyme immunization) in the history of in vitro diagnostics development.
NGS imported into the hospital to create a large number of sales and service demand: NGS in the field of precision medicine and accompanying diagnostic value has been widely recognized by clinical experts, but its technology is complex, the standardization of the quality system standardization is the bottleneck of its clinical routine. Even if the product is approved, hospitals still need high-level laboratory or service support to carry out tumor precision medical sequencing in large quantities and in a standardized manner. Therefore, the commercialization and and commercialization of oncology NGS will also create a broad and large market for NGS clinical services. At the same time, from the business model considerations, NGS products in the terminal sales, academic promotion and after-sales service needs will also be a major test of the industry's terminal capabilities of enterprises, the head of the competitive advantage of enterprises is expected to be further amplified.
Risks
Product R&D declaration is not up to expectations; product sales after listing is not up to expectations; terminal popularization speed is not up to expectations; competition intensification leads to price cuts beyond expectations.