Biotechnology industry: The first second-generation tumor sequencing companion diagnostic was approved, opening a new era of precise tumor diagnosis and treatment

Events

On July 23, 2018, the Food and Drug Administration (CFDA) issued the "Notice of Release of Production Approval Document on July 23, 2018". Among them, the "Human EGFR/ALK/BRAF/KRAS gene mutation joint detection kit (reversible end termination sequencing method)" applied by Guangzhou Burning Rock Medical Laboratory Co., Ltd. has obtained approval for production. This product will become the first domestic product to obtain CFDA Approved NGS tumor multigene detection kit.

Comments

The first second-generation sequencing (NGS) tumor companion diagnostic is approved: This kit is China’s first approval based on high-throughput sequencing technology (NGS) and companion diagnostic standards The multi-gene tumor mutation joint detection kit will be used to help patients with non-small cell lung cancer accurately select targeted drug treatments.

Companion diagnostic products have higher application thresholds than general in vitro diagnostic products. In September 2016, the Food and Drug Administration approved the kit as China's first tumor NGS detection product to enter the "Special Approval Procedure for Innovative Medical Devices" ”, after clinical sample verification and registration production quality system review, it successfully obtained the first tumor NGS certificate, which took nearly 2 years.

In addition to Burning Rock Medicine, domestic companies engaged in the application of tumor NGS products include Aide Biotechnology, BGI and many other companies, such as Aide Biotechnology’s human BRCA1 gene and BRCA2 gene mutation detection reagents kit (reversible end termination sequencing method), human cancer multi-gene mutation joint detection kit (reversible end termination sequencing method); BGI's EGFR/KRAS/ALK gene mutation joint detection kit (combined probe-anchored polymerization sequencing method) ), BRCA1/2 gene mutation detection kit (combined probe-anchored polymerization sequencing method), etc. Several tumor sequencing-related products have successfully entered the special approval process for innovative medical devices.

The U.S. FDA has approved a number of NGS-based companion diagnostic products (such as Foundation Medicine’s FoundationFocus CDx BRCA and Thermo Fisher’s Oncomine DX Target Test), and the domestic regulatory approval of related products is also In line with international standards.

Previously, similar products with registration certificates in China were mainly based on the PCR (molecular amplification) platform. Its advantages are low price, simple method and easy to carry out in hospitals, so it has quickly gained popularity. However, the second-generation sequencing method has much better coverage, detection throughput and detection sensitivity than other methods. Patients only need to undergo one test to understand the panoramic view of hotspot and non-hotspot mutations in multiple tumor treatment-related genes at the same time, and include the key points. Various variation forms such as mutations, insertions and deletions, rearrangements (fusions), etc. provide doctors and patients with a one-stop testing solution for multiple targeted drugs, saving testing samples and testing time. The approval of this product means that NGS has achieved a leap from LDT (laboratory self-built project) to IVD (formal in vitro diagnostic product) in the field of tumor diagnosis, and can be officially used in various hospitals or third-party hospitals with NGS testing capabilities and qualifications. The third-party testing laboratory is a milestone.

The application of NGS will also open up new market space for accurate tumor diagnosis: from a pricing perspective, NGS sequencing is much more expensive than PCR platform products due to the superiority and complexity of its technology. Therefore, NGS sequencing The popularization of precision oncology products is conducive to increasing the overall market size, similar to the improvement of the overall market space by chemiluminescent immunoassay (compared to enzyme-linked immunoassay technology) in the history of in vitro diagnostics development.

The introduction of NGS into hospitals creates a large demand for sales and services: The value of NGS in the field of precision medicine and companion diagnosis has been widely recognized by clinical experts, but its technology is complex and standardization of quality systems is its clinical routine. development bottleneck.

Even if the product is approved, hospitals will still need high-level laboratory or service support to carry out precision cancer sequencing in large quantities and in a standardized manner. Therefore, the commercialization and commercialization of tumor NGS will also create a broad and huge NGS clinical service market. At the same time, considering the business model, the demand for terminal sales, academic promotion and after-sales service of NGS products will also pose a major test to the terminal capabilities of enterprises in the industry, and the competitive advantages of leading enterprises are expected to be further amplified.

Risk Warning

The product R&D application did not meet expectations; the sales after the product was launched did not meet expectations; the terminal popularization speed did not meet expectations; intensified competition led to price cuts that exceeded expectations.