Anbiping Launches Domestically Developed ALK Gene Rearrangement Detection Kit (FISH Method) – Featured in Artery Select Product Showcase Episode 51

ALK (anaplastic lymphoma kinase) gene rearrangement is another classic target for tyrosine kinase inhibitor (TKI) therapy after EGFR. The prevalence of ALK gene rearrangements in non-small cell lung cancer (NSCLC) in China is approximately 5.6%, with a rate of 6.6%–9.6% among patients with adenocarcinoma. In recent years, significant breakthroughs have been achieved in the development and clinical application of ALK inhibitors. Selecting accurate, rapid, and appropriate ALK detection methods to identify the target population suitable for ALK inhibitor therapy holds substantial clinical significance.

Since the approval and market launch of crizotinib in 2011,Currently, three generations of ALK-TKI drugs are available for clinical use.Delivers significant clinical benefits to patients with advanced ALK-positive non-small cell lung cancer.

The approval of the “ALK Gene Rearrangement Detection Kit (Fluorescence In Situ Hybridization Method)” marks the ninth Class III medical device registration certificate obtained by LBP’s FISH platform. FISH, also known as fluorescence in situ hybridization technology, offers high specificity and sensitivity, making it aGold Standard。

March 29 (Friday) at 20:00, VCBeat Selects New Product Review Session No. 51 invitesDeputy Director, Department of Pathology, West China Hospital, Sichuan University, Wang Weiya、Chen Shaoyu, Deputy General Manager of LBP & Director of the Technical Consulting and Application Expert Committee, bringing itsALK Gene Rearrangement Detection Kit for Companion Diagnostic Testing of CrizotinibProduct Introduction.

Figure: ALK Gene Rearrangement Detection Kit (Fluorescence In Situ Hybridization)

NMPA Registration No. 20243400362

1. Both domestic and international guidelines for the diagnosis and treatment of non-small cell lung cancer (NSCLC) give a Level 1 recommendation for testing this target, and it is “Gold Standard"the existence of"

2. Both the sensitivity and specificity of the kit are>98%

3. TestingShort Cycle, issue reportTime Flies

4. A total of 1,000 valid samples were tested in the clinical study, with positive agreement rate, negative agreement rate, and overall agreement rate all reaching100%

5. Analysis of patients with ALK-positive locally advanced or metastatic non-small cell lung cancer (clinical stage IIIB or higher) who meet the indications for crizotinib as a companion diagnostic drugSample size of 300 cases, the test results of this kit are comparable to those of the original companion diagnostic reagent,The positive agreement rate was 100.00%, and the negative agreement rate was 100.00%.

This kit is based on the fluorescence in situ hybridization (FISH) platform and featuresHigh sensitivity and strong specificity, enabling in situ detection on tissue sections., to gain an intuitive understanding of the characteristics of ALK gene alterations.

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Wang Weiya

Deputy Director, Department of Pathology, West China Hospital, Sichuan University

Associate Professor / Master's Supervisor

Member of the 13th Infectious Pathology Group, Pathology Branch, Chinese Medical Association

Member of the Lung Cancer Pathology Group, Committee on Tumor Pathology, China Anti-Cancer Association

Standing Committee Member, Pathology Professional Committee, Sichuan Medical Association

Chairman of the Clinical Pathology Branch, Chengdu High-Tech Medical Association

Completed one Young Scientists Fund project under the National Natural Science Foundation of China; published 23 SCI-indexed papers and 7 Chinese-language papers as first or corresponding author.

Chen Shaoyu

Deputy General Manager of LBP

Director of the Technical Consulting and Application Expert Committee

Ph.D., graduated from Sun Yat-sen University with a major in Biochemistry and Molecular Biology

Since 2003, he has been engaged in the research and development of molecular diagnostic reagents, with substantial R&D expertise in quantitative fluorescent PCR, fluorescence in situ hybridization (FISH), and high-throughput sequencing technologies. He currently serves as Deputy General Manager and Management Representative at Guangzhou LBP Medicine Science & Technology Co., Ltd., overseeing R&D operations.

Since joining the company, I have assisted in establishing the FISH technology platform and independently developed and mastered FISH probe labeling technologies. I led the development of over 400 probe reagents, covering diagnostic and therapeutic applications in solid tumors, hematologic malignancies, reproductive health, and other related fields.

Guangzhou LBP Medicine Science & Technology Co., Ltd. (Stock Code: 688393) specializes in cancer screening and diagnosis, serving hospital pathology departments. Integrating R&D, production, marketing, services, and education into a unified framework, the company has established four core business segments: cancer screening, precision diagnostics, digital and intelligent pathology, and pathology services. It stands as one of the enterprises with the most comprehensive and diverse product portfolio in China’s pathological diagnosis sector.

Since its establishment in 2005, LBP has remained focused on its core business, pursuing meticulous development and building a diversified technology platform. The company has independently developed multiple core technologies, including sedimentation-based liquid-based cytology, reverse dot blot PCR preparation, real-time fluorescent PCR preparation, FISH probe labeling, IHC pathological diagnostic antibody screening and quality control, as well as the manufacturing of related supporting instruments. As one of the domestic manufacturers with the most comprehensive and diverse product portfolio in the field of pathological diagnosis, LBP is capable of meeting the needs of medical institutions at various levels.

Both the Company and its subsidiary, LBP Automation, have obtained National High-Tech Enterprise Certificates. Sixteen core products have been awarded the title of “Guangdong Province High-Tech Products.” The Company has also received numerous honors, including recognition as a 2018 Guangdong Innovative Enterprise (Pilot) and designation as the Guangdong Pathological Diagnosis Engineering Technology Research Center. Its products have passed CE certification, British Standards Institution (BSI) certification, and quality certification by Japan’s Ministry of Health, Labour and Welfare.

LBP has participated in numerous major national projects under the “863 Program,” as well as provincial and municipal research initiatives. The company has been granted 61 patents, including 15 invention patents, and has secured 29 software copyrights. It currently holds more than 500 registered or filed products, with the number continuing to grow. Leveraging the synergistic advantages of its proprietary reagents and instruments, a comprehensive marketing network, and a high-quality service system, LBP’s products have reached nearly 1,800 medical institutions across China.

“Artery Select New Product Showcase” is a live-streaming program under the “Artery Select” brand, dedicated to supporting medical enterprises in launching innovative products. The program’s mission is to facilitate the milestone launch of every innovative medical product.

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