InKanglai Submits IPO Prospectus Highlighting Its Proprietary f-NGS Technology (MicrobDx®) for Precision Diagnosis of Infectious Diseases

From the perspective of the historical development of medical laboratory science, clinical diagnostic technologies have evolved over thousands of years. Progressing from the traditional methods of inspection, auscultation and olfaction, inquiry, and palpation, to structural anatomical observation of tissues and organs and X-ray imaging, then advancing to cellular-level detection using microscopy, these technologies have now reached the stage of detecting biomarkers such as genes and proteins at the molecular level.

In the field of clinical microbiology testing,Although traditional culture-based identification methods are technically mature and have developed steadily, limitations inherent to culture techniques (such as temperature and culture media requirements) result in low detection efficiency, as the majority of pathogenic microorganisms are unculturable.

On the one hand, traditional diagnostic methods for pathogenic microorganismsThe range of detectable species is limited, with a positive detection rate of only 10%–30%., making it difficult to meet clinical needs; on the other hand,Traditional methods rely heavily on empirical judgment., which places high demands on the technical skills of clinical laboratory personnel.

Currently, the areas experiencing significant growth areMetagenomic Next-Generation Sequencing (mNGS) TestingThe technology is not perfect.Due to limitations in detection principles and cost, the signal-to-noise ratio of the assay is low., TestingLow volume of valid data, resulting inLimited detection sensitivity and specificity, high testing costs, andInability to achieve widespread adoptionsuch issues.

So, is there a detection technology that offers both high sensitivity and cost-effectiveness? Perhaps Xi’an Inquire Life Diagnostics, Inc. (hereinafter referred to as “Inquire Life”) can provide the answer.

Inquire Life was established in January 2015, founded by an expert team led by Dr. Jiang Shan, with investment participation from the Chinese Academy of Sciences. The company possesses proprietary intellectual property rights and technical capabilities, and is aR&D, Sales, and Technical Services for Clinical Molecular Diagnostic Products Based on High-Throughput Genetic Testing and Big Data Analyticsa high-tech medical testing company. The enterprise has established the Xi’an Zhongke Inquire Life Medical Laboratory (abbreviated as “Inquire Life Medical Lab”), an independent third-party clinical medical laboratory approved by the Shaanxi Provincial Health and Family Planning Commission.

The company focuses on the rapidly growing “precision medicine” industry. Leveraging high-throughput genomic science as its core, and integrating innovative big data computing and analytics technologies, it provides clinical genetic testing and molecular diagnostic products and technical services for healthcare fields such as infectious disease diagnosis, personalized medicine, reproductive health, genetic disease diagnosis and screening, and disease risk assessment.

The company possesses a globally uniquePrecision Diagnostic Technology for Infectious Diseases: f-NGS, and developed based on f-NGSMicrobDx: Comprehensive Pathogenic Microorganism Detection Platform^®, bringing advancements to the diagnosis and treatment of infectious diseasesNovel Clinical Testing Solutions for Pathogenic Microorganisms。

Currently, the company’s core business areas include: diagnosis of infectious diseases; obstetrics, gynecology, and reproductive health; personalized cancer therapy; and personalized medication guidance for other diseases.

Dr. Jiang Shan, the company’s founder, general manager, and chief scientist, is a visiting researcher at the Chinese Academy of Sciences and a seasoned expert in genomics, bioinformatics, and oncology pharmaceuticals. Dr. Jiang earned his degree from the Johns Hopkins University School of Medicine, where he studied under Daniel Nathans, Nobel Laureate in Physiology or Medicine and former president of Johns Hopkins University. After graduation, he served as Chief Scientist at Gilead Sciences and has led multiple major research initiatives, including projects funded by the U.S. National Institutes of Health (NIH) Small Business Innovation Research (SBIR) program and the Innovation Fund of China’s Ministry of Science and Technology.

Dr. Jiang Shan also founded Suzhou Aisipeng Pharmaceutical R&D Co., Ltd., pioneering the practice of Chinese pharmaceutical companies licensing innovative drug patents to overseas pharmaceutical firms.

Furthermore, the core team members hail from prestigious medical and research institutions, enterprises, and hospitals, including the Johns Hopkins University School of Medicine, the Chinese Academy of Sciences, AstraZeneca Pharmaceuticals, the Nasdaq Group, and leading domestic Grade 3A tertiary hospitals. They possess extensive international and domestic industry and academic experience in genomics, clinical laboratory testing, data analytics, and information software platforms.

When asked why the company chose infectious disease diagnostics as the direction for developing its precision medicine technology products, Jiang Shan said, “For a startup with limited resources, focusing on a vertical sector enables faster progress and facilitates rapid growth. In terms of market selection, we initially considered three areas: non-invasive prenatal screening, precision oncology diagnostics, and infectious disease diagnostics.”

Jiang Shan stated, “Non-invasive prenatal screening entered a phase of intense market competition in 2016, it will be difficult to achieve outstanding results if entering this sector;Precision diagnosis of tumors is further constrained by low clinical penetration, a lack of effective drugs, and dependence on the advancement of therapeutic modalities., so it is not considered. HoweverThe market for infectious diseases is large with substantial demand, and the primary clinical pain point lies in diagnosis., so weIn response to market demand, we have chosen the field of infectious disease diagnostics.。”

Nowadays,Three of the top 10 global causes of death are infectious diseases, accounting for 10% of all deaths.In low-income countries worldwide, the vast majority of deaths are caused by infectious diseases. In terms of patient volume,Infectious diseases account for 49% of all medical consultations in China, with approximately 20 million patients suffering from complex and critical infections each year.As a mature field, the treatment of infectious diseases currently has hundreds of therapeutic drugs available, with targeted treatment options for nearly every pathogenic bacterium.

Faced with such a vast market and well-established treatment modalities, accurate diagnosis has become the current market demand for infectious diseases. Inquire Life Diagnostics, Inc. is built upon this market demand and has inventedThe globally pioneering “full-length characterization sequence NGS sequencing (f-NGS)” technology, and developed the Jianwei based on f-NGS technology^®（MicrobDx^®) One-stop product solution. f-NGS is a new technology for pathogenic microorganism detection based on next-generation sequencing (NGS), offering advantages such as comprehensive profiling, high sensitivity, high accuracy, and cost-effectiveness.

Compared with traditional culture and identification techniques, which can only detect common and easily identifiable pathogens, MicrobDx^®Technologically feasibleComprehensive Identification and AuthenticationDifficult to Detect Using Traditional MethodsPathogenic microorganisms, including bacteria, archaea, fungi, mycoplasma, chlamydia, spirochetes, rickettsiae, and parasites, comprise a total of 21,844 species. Among these, there are 20,079 prokaryotic microbial species with 180,240 sequences in the database, and 1,765 eukaryotic microbial species with 105,478 sequences in the database.

MicrobDx^®The technology features high detection performance,Pathogenic bacteria detectable at microbial loads as low as 10 CFU per sample, significantly improving the detection efficiency of clinical specimens; andWhen the microbial load in the sample is ≥10⁻²⁴ CFU, the detection sensitivity can reach 100%.. In addition, MicrobDx^®The technology demonstrates robust detection capabilities for samples with multiple infections, significantly outperforming culture-based identification methods. On the other hand, whenWhen the microbial load in the sample reaches 160 CFU，MicrobDx^®TechnicalDetection accuracy (PPV) can reach 100%。

MicrobDx^®Full-Spectrum Pathogenic Microorganism Clinical Detection Kitwhile facilitating rapid identification of pathogenic microorganisms, its detectionCosts only one-fourth that of metagenomic testing, suitable for extensive clinical applications.

Due to Inquire Life MicrobDx^®With its high cost-effectiveness and high precision, the company has partnered with multiple benchmark hospitals, including Tangdu Hospital of the Fourth Military Medical University, Xijing Hospital of the Fourth Military Medical University, and the First Affiliated Hospital of Xi’an Jiaotong University.Long-term Clinical Collaborations Established with Over 40 Hospitals。

To date, Inquire Life has completed MicrobDx^®1.0 Development of a Full-Spectrum Pathogenic Microorganism Detection Platform, Including Reagents, Workflows, Software, and Cloud Platform; Jianwei^®（MicrobDx^®) The clinical test kit for full-spectrum pathogenic microorganisms has entered the procurement process of large tertiary hospitals, and a customer base composed of hospitals at all levels has been established. The company has obtainedMultiple Class I IVD filing certificates, multiple invention patent applications filed, 6 software copyrights approved, and nearly 100 precision medicine diagnostic service items launched.. To date, Inquire Life Diagnostics LaboratoryOver 200,000 samples have been tested, with a maximum daily testing capacity of 5,000 samples.

Currently, Inquire Life Diagnostics is planning its Series A financing round, aiming to raise tens of millions of RMB. The proceeds will be allocated to rapid market expansion, technological upgrades and iterations, and capacity expansion. Looking ahead, Inquire Life Diagnostics will align with global trends such as increasing population mobility, the widespread dissemination of drug-resistant bacteria, and the frequent emergence of new infectious diseases, as well as healthcare market demands, to further upgrade MicrobDx.^®Leveraging technology in conjunction with cloud service platforms significantly accelerates product market penetration and expands market scale.