since 2020
Focus on fungal infections, increase diagnostic rates and reduce mortality
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Project Introduction

Epidemiology situation

The Mycology Laboratory project provides international standard testing and clinical precision treatment programs for fungal infections in medical institutions in China and Asia Pacific.

Fungal infections are classified into superficial fungal infections and invasive fungal infections (IFD's). In recent years, due to the transplantation of medical technology, the development of catheterization, the use of immunosuppressive agents and anti-tumor chemotherapy drugs, the use of a large number of antibiotics has led to the emergence of more and more immunodeficient hosts and drug-resistant strains, which makes the field of fungal infections a huge challenge.

According to incomplete statistics, 1 billion people worldwide are affected by fungal infections. 310 million people are infected with fungi, more than 30 million are caused by lethal fungal infections, and only 2 to 3% of invasive fungal diseases (IFD' S) Patients can be effectively diagnosed and treated. Invasive fungal infections have the characteristics of high infection rate, high mortality, low diagnostic rate and low treatment rate. Taking invasive Aspergillus infection as an example, the mortality rate is as high as 50% to 100%, which has exceeded cancer!

In 2016, the market size of antifungal drugs in public hospitals in key cities in China has reached 2.075 billion yuan, an increase of 88% in the scale of anti-fungal drugs in public hospitals in 2010, which was 1.106 billion yuan. The national market has exceeded the scale of 22 billion yuan.

Huang Xiao Jun, a blood transplant specialist at the Peking University Institute of Hematology, announced for invasive fungal infections to be invasive aspergillosis, which has a poor prognosis and a mortality rate of 60%-90%. Early intervention, early diagnosis, and early treatment are the key factors for doctors in the blood, respiratory, and ICU fields to improve the survival rate of patients with invasive fungal diseases and reduce the overall economic burden of society.

Solution for the market demand

Mycology situation in China

1) Asia-Pacific Fungal Laboratory Survey Data (Source: International Society for Human and Animal Fungi, 2017. 1)Data from 7 countries, 241 laboratories: 71 China, 104 India, 11 Indonesia, 26 Philippines, four Singapore, 18 Taiwan and 7 Thailand

 Advanced diagnostic tests such as galactomannan (GM), β-D-glucan (G) and PCR are almost impossible to obtain in surveyed laboratories in Indonesia, the Philippines and Thailand.

 The key issues: the market needs to develop high-quality laboratories, certification and manpower training in existing laboratories, and to obtain advanced non-culture diagnostic tests to facilitate the diagnosis of fungal infections in Asia.

 The availability of laboratories in China (38 / 71, 53.5%) and Indonesia (7 / 11, 63.6%) is relatively low

 Laboratory antifungal susceptibility testing; 5/136 (3.7%) laboratory (China 4/31 and Philippines 1/9) outsourcing testing

 Six laboratories in China (6 / 31, 19.4%) and four laboratories in India (4 / 73, 5.5%) use internally developed antifungal susceptibility testing methods (do not follow any commercial or standardized tests, such as CLSI or EUCAST).

2) Fungal diagnosis is combinatorial and is detected and judged by a comprehensive method. The main methods are microscopic, immunological detection and PCR. At present, the national fungal laboratory is based on basic research and cannot serve most clinical needs (Molecular Research Laboratory of Chinese Academy of Sciences, Peking University Fungal Research Institute, Shanghai Fungal Molecular Laboratory; Fungal Research Laboratory of Peking Union Medical College Hospital, Fungus Laboratory of Hua Shan Hospital). 

The hospital laboratory has no standard for fungal detection and diagnosis. Many test methods are mess. Due to the limitation of fees, PCR detection cannot be performed. For a variety of reasons, most hospital laboratory departments cannot make accurate judgments for clinical drug treatment.

Mainly highlight the pain points:

• Large clinic needs: all infections in the hospital are routinely tested for fungal culture, 100 cases/day (special transplant, ICU, respiration)• Long detection period: 100 cases/week for GM identification; usually 3-5 days;

• Lacking test method, impact accuracy: hospital turnover rate is fast, patients cannot get comprehensive fungal detection, affecting the accuracy of results

• Lack of professionals: no one is promoted, the data is limited and it is difficult to carry out molecular testing. Currently, molecular diagnosis cannot be used.

• Lack of large databases and pathology interpretation experts:

 lack of drug susceptibility experiments and report interpretation

• Medications are not available: clinically specific strains cannot be given, so that doctors experience medications that can lead to liver and kidney damage.
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