Vietnamese firm pioneers manufacture of diagnostic biochips

13:00 | 30/05/2020 Science - Technology

(VEN) - The Biotechnology and Medical Device Technology Factory Company Limited (BIMEDTECH) has implemented a pioneering project in Vietnam in the field of manufacturing, researching and developing high-tech chip products for the diagnosis of genetic disorders and infectious diseases.

vietnamese firm pioneers manufacture of diagnostic biochips
BIMEDTECH staff working on the project

Research efforts

In 2016, the Ministry of Industry and Trade (MOIT) approved the project on researching and manufacturing biochips based on DNA microarray technology to diagnose human disease, within the framework of a national program on development of high-tech industries. In 2018, BIMEDTECH became the first company in Southeast Asia to produce biochips.

In the first phase of the project, the researchers conducted a survey of known gene mutations found in internationally manufactured biochips, some new or specific gene mutations in humans and agents in Vietnam related to diseases like congenital hemolysis, tuberculosis, and Clopidogrel resistance in patients with cardiovascular intervention.

Next, BIMEDTECH cooperated with high-tech companies in the US and Europe to receive the transfer, develop and master the technology of manufacturing DNA and Protein Microarray, a platform to develop products for diagnosis of some human diseases.

BIMEDTECH also invested in modern factories with fully equipped facilities, including production workshops, microbiology and quality control rooms, testing and packaging divisions, warehouses; ISO 13485: 2016 quality management system and GMP-WHO standards to meet regional and international high-tech production requirements.

Three successful products

The project is currently developing three products. The first is the BIMEDCHIP® Thalassemia Detection Kit for the diagnosis and treatment of congenital hemolytic disease (thalassemia), which simultaneously detects many mutations causing congenital anemia in just one test with fast and accurate results and at reasonable cost.

The second product is BIMEDCHIP® Non-tuberculous Mycobacteria Panel Kit used for the diagnosis of tuberculosis. The kit provides results within about six hours, compared to other methods that can take weeks. The production of fast and accurate results helps health workers provide an effective, timely and beneficial treatment regimen for patients.

Finally, the BIMEDCHIP® Cardiovascular Drug PGx Testing Kit can detect whether gene expression is related to the metabolism of Clopidogrel, Statin, Sinthrome in patients’ livers, helping health workers choose the right and most effective dose or drug for each patient.

Within the framework of the project, BIMEDTECH manufactured three pilot lots of 1,000 chipsets each under close cooperation and quality testing of leading units in the diagnosis and treatment of blood, lung and heart disease, such as the National Institute of Hematology and Blood Transfusion and the National Lung Hospital. BIMEDTECH will pilot the production of 30,000 chipsets for diagnosis and screening of congenital hemolytic, 10,000 chipsets for identification of 17 atypical tuberculosis strains and 10,000 Clopidogrel-resistant diagnostic chipsets.

After completing the technological production process, BIMEDTECH will apply for certification for all three chipsets and then apply them in the diagnosis and treatment of related diseases in Vietnam.

Quynh Nga