Shanghai GeneoDx Biotech Co., Ltd. (GeneoDx) is a subsidiary of China National Biotec Group Company Limited (CNBG), China National Pharmaceutical Group Co., Ltd. (Sinopharm). GeneoDx is a professional R&D, production, and sales company of domestic and foreign medical devices and in vitro diagnostic reagents.
Medical diagnosis is one of the key sectors in the development of CNBG's planning. GeneoDx undertakes this part in CNBG. It is also the first company leading CNBG's mixed ownership reform, aiming to promote the rapid development of diagnostic business with institutional innovation. As a unified operation platform company of CNBG's diagnosis sector, GeneoDx integrates functions of R&D, production and trade. By means of independent research and development, technology import, investment, merger and acquisition, it has built a large industrial chain of CNBG's diagnosis sector, and strives to become a leader in the domestic subdivision field. In 2019, GeneoDx completed the first acquisition project of a foreign company within Sinopharm Group, launched the construction of an overseas R&D center, therefore, further accelerated the introduction of global leading technology and broadened the layout overseas.
Novel Coronavirus 2019-nCoV Nucleic Acid Detection Kit (Real Time PCR)
First batch to get registration certificate
Novel Coronavirus 2019-nCoV Rapid Detection Kit (LAMP)
Export whitelist of epidemic prevention materials, CE certification
Novel Coronavirus（SARS-CoV-2）Neutralizing Antibody Detection Kit (ELISA)
Export whitelist of epidemic prevention materials, CE certification
"Great Wall" gas film laboratory, shelter laboratory
Rapid completion, to help improve nucleic acid capacity
The DNA Methylation Detection Kit for Human ASTN1、DLX1、ITGA4、RXFP3、SOX17、ZNF671 Gene (Cervical Cancer) qualitatively detects the methylation status of 6 genes in human cervical exhumation cells in vitro to evaluate whether the abnormal population with preliminary screening results has the risk of cancer, and distinguish the population with high probability of self-healing and high risk of cancer. So as to carry out triage management, avoid excessive diagnosis and treatment, truly achieve individualized and precision medicine, reduce the physiological, psychological and economic burdens of patients, and optimize the allocation of medical resources.
Pneumocystis jirovecii (P. jirovecii) is an opportunistic pathogenic bacterium that lives in the lungs. Tumors, etc., can cause Pneumocystis pneumonia (PCP). The clinical manifestations of PCP are non-specific. Most patients present with fever as the first symptom, followed by symptoms such as chest tightness, shortness of breath, dry cough with less sputum, and dyspnea. The progression is rapid and the mortality rate is high.
The Aspergillus series kit consists of an optimized mix of target-specific primers and probes for the detection of Aspergillus fungi and the identification of genetic mutations associated with polyazole resistance. Based on multiplex PCR technology, the kit uses fluorescent probes and melting curves to identify the tandem repeat sequence TR34 and SNP sites L98H, T289A and Y121F in the CYP51A gene of Aspergillus fumigatus, thereby distinguishing wild-type and drug-resistant strains.
This kit is based on multiplex fluorescent PCR technology, which is realized by fluorescent probes in the mixture. Amplification and melting curve analysis are performed on a real-time fluorescent PCR instrument, and fluorescence in green, yellow, orange and red channels can be detected.
This kit is used for in vitro qualitative detection of monkeypox virus F3L gene in serum samples, exudates from lesions or respiratory tract swab samples (oropharyngeal swab and nasopharyngeal swab) of suspected monkeypox cases or other cases that require monkeypox virus infection diagnosis or differential diagnosis.
The reagent kit can simultaneously detect the nucleic acid of ten pathogens of urinary and reproductive system infections, quickly and effectively identify the pathogen species of patients with urinary and reproductive system infections. Combined with other clinical and epidemiological information, it will help diagnose urinary and reproductive system infections.
The GastroFinder® 2SMART test kit is a test kit that uses SmartFinder® technology for testing. This technology can detect and analyze as much as 30 target genes in one PCR reaction. This test kit first performs reverse transcription amplification to produce cDNA, then divides the reverse transcription product into two parts to carry out two independent 2SMART reactions. The identification method is melting curve analysis.
Meningitis and encephalitis infections are caused by viral, bacterial or fungal infections. The onset is rapid, progresses quickly, and has a high mortality and disability rate. Early diagnosis is of great significance for treatment and prognosis. Traditional cerebrospinal fluid routine, biochemical, staining and culture examinations have shortcomings in diagnostic sensitivity and specificity, which brings difficulties to early diagnosis and differential diagnosis of diseases. This test kit is based on multiplex PCR technology and can qualitatively detect and distinguish the nucleic acids of 22 meningitis pathogens that cause meningitis and encephalitis in the human body within 2.5 hours.
The respiratory pathogen detection kit is based on single-tube multiplex PCR technology, which can detect up to 13 target genes simultaneously in a single PCR. The kit begins with a first-step PCR reaction, which consists of reverse transcription amplification to synthesize a cDNA, followed by dilution of the first-step PCR product, taking a portion of the product and splitting it into two separate second-step PCR reactions. The melting curve was used for analysis.
This product uses a competitive ELISA method for testing. The sample to be tested and the control sample are pre-incubated with SARS-CoV-2 RBD protein to allow neutralizing antibodies to bind with RBD. The mixture is then added to a microplate with ACE2 pre-coated on it. Unbound RBD and RBD bound with non-neutralizing antibodies are captured on the microplate, while the neutralizing antibody-RBD complex remains in the supernatant and is removed during washing cycles. After washing, enzyme-labeled antibody is added and TMB substrate coloration follows. The OD value after the reaction is measured by an ELISA reader. The concentration of SARS-CoV-2 neutralizing antibodies in the sample is calculated from the OD value measured by an ELISA reader.
The 2019 novel coronavirus (2019-nCoV, named by the World Health Organization on January 12, 2020; SARS-CoV-2, named by the International Committee on Taxonomy of Viruses on February 11, 2020). Coronaviruses are a large family of viruses that can cause colds, Middle East respiratory syndrome (MERS), severe acute respiratory syndrome (SARS) or other serious diseases. The SARS-CoV-2 is a new species of coronavirus that has never been found in humans before. Common signs of infection include respiratory symptoms, fever, cough, shortness of breath and breathing difficulties. In some severe cases, infection can cause pneumonia, severe acute respiratory syndrome, kidney failure or even death.
Nucleic acid extraction instrument is an instrument that automatically completes the nucleic acid extraction of samples by using the corresponding nucleic acid extraction reagent. Widely used in disease control centers, clinical disease diagnosis, blood transfusion safety, forensic identification, environmental microbiology detection, food safety detection, animal husbandry and molecular biology research and other fields.
Shanghai GeneoDx Medical Laboratory Co., Ltd. (GeneoDx Medical) was established in March 2022. It is a wholly-owned subsidiary of GeneoDx, and one of the key tasks of China National Biotech Group's planning and development.
GeneoDx Medical is beset with a professional examination team, advanced technology and top-notch equipments and facilities, including Sanger platform, multiplex PCR platform, digital PCR platform, immune platform and information analysis platform. .
GeneoDx Medical features the detection of tumors and pathogenic microorganisms. By optimizing the allocation of health resources such as medical testing technology, equipment and personnel, it can help in the achievement of graded diagnosis and treatment, alleviation of the workload of medical institutions, decline of medical costs, and complement of diverse medical resources, so as to provide high-quality services to patients. The testing services provided are in the fields of sexually transmitted diseases, prenatal and postnatal care, respiratory pathogens, microbial drug resistance, fungi, oncology, etc.
Through cooperation with medical institutions and scientific research institutions, GeneoDx Medical deeply explores academic research related to diseases diagnosis/control and treatments, jointly applies for national, provincial, municipal and regional projects of Natural Science Foundation, and tracks and develops new technologies, new products and new services. For the continuous improvement of diagnostic technology and academic status of medical institutions at all levels in the region, it will relentlessly pursue its efforts to meet the needs of hospitals and scientific research institutes.
Since its establishment, GeneoDx Medical has established a quality management system in strict accordance with the requirements of ISO15189 and CAP to ensure the accuracy and stability of test results, promote mutual recognition of reports, regionalization of coverage and integration of basic data of laboratory management information collection to meet the needs of medical research, health administration and public health management.
GeneoDx Medical adheres to the corporate philosophy of "All for health, health for all", with independent R&D results and imported technology, is committed to the realization of "guarding life and health with scientific and technological power".
(1) Provide the design scheme of the structure, water and electricity facilities and regional layout of the medical laboratory;
(2) Provide the overall operation plan of medical nucleic acid laboratory, including main equipment list, personnel configuration, sampling workflow, nucleic acid testing workflow, quality control and logistics support;
The 5th China International Import Expo (hereinafter referred to as "CIIE") will be held at the National Exhibition and Convention Center (Shanghai) from November 5th to 10th, 2022. In the afternoon of November 5th, Sinopharm CNBG Shanghai GeneoDx Biotech Co., Ltd. (hereinafter referred to as "GeneoDx") signed a strategic cooperation agreement with China Travel Service (Macao) LTD. (hereinafter referred to as "CTS Macao"), a subsidiary of Nam Kwong (Group) Company Limited, to collabrate in medical testing, medical tourism and other fields.
Recently, the 2022 China International Fair for Trade in Services ("CIFTIS") was held in Beijing. Sinopharm Group demonstrated to the public the latest scientific and technological achievements of SARS-Cov-2-Vaccine, therapeutic drugs, and diagnostic reagents with the "Technology Anti-epidemic China Plan". Among them, as one of the important activities of Sinopharm Group at the CIFTIS, the DNA Methylation Detection Kit for Human ASTN1、DLX1、ITGA4、RXFP3、SOX17、ZNF671 Gene - Cervical Cancer developed by GeneoDx officially debuted in Beijing. Liu Jingzhen, Chairman of the Sinopharm Group, Yang Liu, Deputy Secretary of the Party Committee of Sinopharm Group, Zhu Jingjin, Secretary of the Party Committee of Sinopharm, and other leaders and experts attended the press conference.
On August 4, 2022, the DNA Methylation Detection Kit for Human ASTN1、DLX1、ITGA4、RXFP3、SOX17、ZNF671 Gene -- Cervical Cancer developed by Shanghai GeneoDx Biotech Co., LTD. (hereinafter referred to as GeneoDx) of Sinopharm CNBG has been registered as a medical device issued by the NMPA. This is the first certificate for HPV primary screening methylation triage for cervical cancer in China.
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Adhering to the corporate philosophy of "caring for life and health", the company strives to build a large industrial chain of CNBG's diagnostics sector and strive to become a domestic first-class and internationally well-known enterprise in the field of molecular diagnostics and precision medicine.
With "courage to take responsibility, unity and cooperation, forge ahead with determination, continuous innovation" as the talent values.
Through the improvement of staff ability, staff thinking, staff governance, constantly enhance the organizational ability to match the strategic needs of the enterprise, to achieve the vision of the company and staff development.