The 21st China Association of Clinical Laboratory Practice Expo (CACLP) and the 4th China IVD Supply Chain Expo (CISCE) will be held from March 16th to 18th, 2024 at the Chongqing International Convention and Exhibition Center.

Shenzhen Sciarray Biotech Co., Ltd., a national high-tech enterprise from Guangdong, has announced the launch of the world's first gene methylation-based in vitro diagnostic product for non-tumor diseases. Notably, it is also the world's first precision gene diagnostic product specifically targeting autoimmune diseases, specifically Systemic Lupus Erythematosus (SLE) - Systemic Lupus Erythematosus (SLE) IFI44L Gene Methylation Biomarker Detection Kit (Ms-HRM Test) , (Registration Number: 20243400284).

The approval of this product marks the entrance of the complex disease "systemic lupus erythematosus" into the era of gene diagnosis. Its clinical application, combined with other indicators, will significantly improve the diagnostic accuracy of systemic lupus erythematosus, reduce misdiagnosis and missed diagnosis, and is of great significance for the prevention and treatment of the disease.

At the CACLP exhibition, Sciarray Biotech proudly presented its groundbreaking precision diagnostic product for Systemic Lupus Erythematosus (SLE) through gene methylation , alongside its comprehensive range of microarray chip products and new respiratory tract detection offerings. Located at booth N3-1622, the company garnered immense attention from experts, peers, and partners, with a continuous stream of visitors stopping by to inquire and engage in meaningful discussions. Let's revisit some of the exciting moments from the exhibition!

On the morning of March 16th at 10:00 AM, the exclusive global launch event for the novel product, Gene Methylation Test for Systemic Lupus Erythematosus, commenced punctually.

First, Dr. Lin Liancheng, General Manager of Sciarray Biotech, delivered an opening speech. He expressed his gratitude to all experts, scholars, partners, and media friends for their attention and support. Dr. Lin announced the launch of Sciarray Biotech's innovative gene methylation detection reagent product , which is not only the world's first in vitro diagnostic product for gene methylation in non-tumor diseases but also the first precision gene diagnostic product specifically targeting the autoimmune disease, Systemic Lupus Erythematosus (SLE). This marks a solid step forward for Sciarray Biotech in the field of precision medicine for SLE, providing a novel and efficient tool for clinical diagnosis. This achievement is the result of years of research and development efforts by the Sciarray team, as well as a testament to Sciarray Biotech's focus on addressing clinical needs and pain points.

The etiology of systemic lupus erythematosus (SLE) remains unknown, and it is more common among young women. The disease is characterized by involvement of multiple organs and systems, heterogeneity, and persistent illness. Due to the lack of highly sensitive and specific diagnostic biomarkers, early diagnosis, differential diagnosis, and precise diagnosis of SLE are extremely challenging, making its diagnosis and treatment a persistent problem in medical research.

The diagnostic product for Systemic Lupus Erythematosus (SLE) through gene methylation product offers a new possibility for early diagnosis and precise treatment of SLE by accurately detecting the methylation level of the IFI44L gene in human peripheral blood. This is not only a boon for SLE patients but also a contribution to basic medical research and clinical industry-university-research collaboration.

Following Dr. Lin's opening remarks, Professor Li Yongzhe from the Department of Laboratory Medicine at Peking Union Medical College Hospital delivered a captivating lecture titled "Clinical Application of DNA Methylation in the Diagnosis of Systemic Lupus Erythematosus (SLE)."

Professor Li began by outlining the definition, incidence, and current situation of SLE in China, highlighting the challenges faced in clinical diagnosis and treatment. He then introduced the development of epigenetics, focusing on the process of DNA methylation, its role in regulating gene expression, and the latest basic research progress in the field of SLE and other diseases. This led to a discussion on the crucial role of DNA methylation in the occurrence and development of SLE.

Finally, Professor Li shared with the audience the significant basic research achievements made by a team of Chinese scientists on the association between IFI44L gene methylation markers and systemic lupus erythematosus. Through detailed presentations of their research, Professor Li demonstrated the selection, discovery, and validation of the IFI44L gene methylation marker through cohort studies, as well as subgroup studies on organ damage and disease activity. He also presented key evidence from clinical trials of innovative medical devices, further supporting the significant value of IFI44L gene methylation diagnostic markers in the clinical diagnosis of SLE.

Professor Li also pointed out that with the continuous development of modern medical research, new autoimmune disease markers and advancements are constantly emerging, bringing new ideas and scenarios to the diagnosis, treatment, and prognosis of autoimmune diseases. This also forces us to rethink the limitations of current clinical classification standards and immunological indicators in clinical applications, especially for the diagnosis of SLE, a "model disease" in the field of rheumatology and immunology.

With the launch and clinical application of the IFI44L gene methylation product, it is believed that it will effectively promote the improvement of precision medicine for lupus erythematosus, bringing new hope to SLE patients worldwide. At the same time, it will also promote the research and application of DNA methylation detection technology in the field of non-tumor diseases. Professor Li's engaging lecture content attracted positive feedback and lively discussions from hundreds of colleagues in the field of laboratory medicine.

Subsequently, Mr. Huang Qicheng, General Manager of the Marketing Center of Sciarray Biotech, delivered a lecture titled "Introduction to the Unique Features and Investment Policies of Our Global Exclusive New Product."

Mr. Huang systematically introduced Sciarray Biotech's independently developed IFI44L gene methylation detection kit . This product is the world's first non-tumor gene methylation in vitro diagnostic product and also the first gene-based precision diagnostic product specifically for systemic lupus erythematosus (SLE). Its launch fills the international gap in genetic diagnosis for SLE and has the potential to be included in existing international SLE diagnosis and treatment guidelines.

The launch of  IFI44L gene methylation detection kit , not only represents another significant breakthrough for Sciarray Biotech in the field of precision medicine for autoimmune diseases, but also signifies the entry of diagnostic technology for systemic lupus erythematosus into the era of genetic diagnosis. This product brings new hope to the vast number of patients with SLE. The availability of IFI44L gene methylation detection kit , as a rapid and accurate auxiliary diagnostic tool for SLE will greatly facilitate CellBio's market expansion in the field of autoimmune disease diagnosis.

Sciarray Biotech aims to significantly enhance the diagnostic accuracy of systemic lupus erythematosus through the IFI44L gene methylation detection kit, thereby reducing misdiagnosis and missed diagnosis, and ultimately improving the treatment outcomes and quality of life for patients.

Sciarray Biotech will continue to focus on the hundreds of millions of people in the autoimmune market, providing high-quality diagnostic solutions and products to a broader population of patients with autoimmune diseases.

The subsequent event was the official launch ceremony for the global exclusive new product . The ceremony was jointly initiated by Professor Li Yongzhe, leaders from Sciarray Biotech, and special guests, bringing the entire launch event to a climax. Everyone expressed high hopes for the excellent performance of the product and the future of precision diagnosis in the field of autoimmunity.

During the exhibition, Sciarray Biotech continued to strengthen its domestic collaborations for new products and held a signing ceremony for the strategic partnership of its globally exclusive new product . The company officially signed agreements with renowned domestic distributors from across the country to establish strategic partnerships.

The launch of IFI44L gene methylation detection kit not only represents another significant breakthrough for Sciarray Biotech in the field of precision medicine for autoimmune diseases, but also signifies the entrance of diagnostic technology for systemic lupus erythematosus into the era of genetic diagnosis. It brings renewed hope to the vast number of patients with SLE.

With the availability of IFI44L gene methylation detection kit as a rapid and accurate auxiliary diagnostic tool for SLE, it will greatly facilitate the expansion of the market for precision diagnosis of autoimmune diseases.

Based on the need for long-term development of both parties, a deep strategic cooperation has been reached. Both sides have committed to fully leveraging their respective advantages in products, technology, market, team, and resources to jointly explore the market, achieve win-win cooperation, and promote precision diagnosis and treatment. This collaboration aims to significantly improve the diagnostic accuracy of SLE, reduce misdiagnosis and missed diagnosis, thereby enhancing the treatment outcomes and quality of life for patients, and ultimately benefiting a wide range of individuals.

Subsequently, Professor Li Yongzhe, leaders from Sciarray Biotech, and special guests posed for a commemorative group photo. The launch event concluded with a round of enthusiastic applause, marking the successful conclusion of the global exclusive new product launch of IFI44L gene methylation detection kit.

The clinical significance of Systemic Lupus Erythematosus (SLE) IFI44L Gene Methylation Biomarker Detection Kit (Ms-HRM Test)：

● Early precise diagnosis

Early precise diagnosis can assist clinicians in the early diagnosis of systemic lupus erythematosus (SLE), including latent lupus or incomplete lupus erythematosus. Early detection, diagnosis, and treatment can help reduce the damage to patients' tissues and organs caused by SLE, improve their quality of life and sense of dignity, and minimize the risk of misdiagnosis and missed diagnosis.

● Differential diagnosis

The early precise diagnosis can also assist clinicians in the clinical differential diagnosis between other autoimmune diseases, such as primary Sjögren's syndrome, primary immune thrombocytopenia, thrombotic thrombocytopenic purpura, psoriasis, dermatomyositis/polymyositis, adult-onset Still's disease, mixed connective tissue disease, neuropsychiatric disorders, and systemic lupus erythematosus. This enhanced precision in diagnosis can significantly improve the accuracy of diagnosing complex and challenging cases.

● Drug Effectiveness Evaluation and Prognosis Monitoring

Applicable for assessing the drug effectiveness and monitoring the prognosis of SLE patients, aiming to enhance the clinical treatment level.

● Reducing Medical Costs

Through gene methylation detection, we can more accurately assist in clinical diagnosis, differential diagnosis, and exclusion of SLE diseases, thereby improving the diagnosis and treatment level of complex and challenging cases. This makes the clinical diagnosis and treatment of rheumatic immune diseases more precise and efficient, leading to reduced medical costs.

● Enhancing the Precision Diagnosis and Treatment Level of Autoimmune Diseases

By introducing genetic diagnostic indicators, we can assist clinicians in the diagnosis, differential diagnosis, and exclusion of autoimmune diseases. This fills the gap in hospitals where there are no genetic precision diagnostic products for rheumatic immune diseases, thereby enhancing the brand reputation and scientific research capabilities of departments and hospitals. It significantly improves the hospital's diagnosis and treatment level for complex and challenging diseases, benefiting the local population.

Looking ahead, Sciarray Biotech will continue to dedicate itself to research and innovation in the field of autoimmune disease diagnosis, continuously introducing more high-quality and efficient diagnostic products. Our goal is to provide better products and services to hundreds of millions of patients with autoimmune diseases worldwide. We believe that through our joint efforts and ongoing innovation, we can bring more hope and brightness to the diagnosis and treatment of autoimmune diseases globally.