Improving the resilience of medical devices is one of the Ministry of Health's priority programs within the framework of the Health Resilience System Transformation. In the effort of medical device resilience, the Ministry of Health focuses on accelerating the production of domestic medical devices. Domestically produced medical devices that have been licensed for distribution, which of course meet the requirements of safety, quality and usefulness, are expected to meet domestic needs independently, and then be able to compete globally, in the export market. For this reason, the medical device industry must have quality that meets global standards.

The Ministry of Health and PT Bio Farma launched BioColoMelt-Dx on Tuesday (19/7) at the Auditorium of Dharmais Cancer Hospital. This new innovation and breakthrough by the nation's children is useful for early detection of colon cancer (colorectal). The BioColomelt-Dx product is an innovation resulting from the collaboration of PT Bio Farma and PT PathGen Diagnostic Technology which involves various industries, research and educational institutions, such as the University of Nottingham in the UK, and has a development lab in Indonesia (LIPI and BRIN labs). Prior to its launch today, BioColomelt-Dx was validated by clinicians from several national hospitals including Dharmais Hospital, Sardjito Hospital and UGM, RSCM and FKUI.

The launching event was attended by Minister of Health Budi, Head of the National Public Procurement Agency (LKPP) Azwar Anas, Director General of Pharmaceuticals and Medical Devices Rizka Andalusia, President Director of Dharmais Cancer Hospital Dr. Soeko W Nindito, and President Director of Bio Farma Honesti Basyir.

Minister Budi said that cancer occurs because of mutations in a person's DNA. In the course of human life the DNA can change and that is what triggers cancer. "To see the DNA changes, PCR is needed. It is a simple technology, cheaper tools like BioColoMelt-Dx. This technology can detect DNA changes in certain positions. If we already know what the DNA changes are, we know exactly what cancer is and where so that the treatment can be faster and more precise.

"So this tool is to diagnose what the cancer is caused by so that the treatment can be faster," added the Minister of Health. For the record, colorectal cancer is another term for cancer that attacks the colon, rectum, or both," said the Minister of Health.

The Minister of Health hopes that PT Bio Farma and PT PathGen Diagnostic Technology can continue to develop a portfolio of domestic in vitro diagnostic medical device products, especially other molecular-based products, so as to encourage the achievement of resilience and independence of medical devices in Indonesia, fulfill the needs of in vitro diagnostic medical devices in Indonesia, and place Indonesia in the global supply chain.

"I urge users of medical devices such as hospitals and other health care facilities, to start using domestic medical devices. By using domestic medical devices, we have contributed positively to the Indonesian economy in advancing and developing the domestic medical device industry and strengthening economic competitiveness both nationally and globally," added the Minister of Health.

This product has obtained a distribution permit from the Indonesian Ministry of Health with the number KEMENKES RI AKD 20306220065 which was released on July 1, 2022. With this BioColoMelt-Dx, patients can get easier access to check the accuracy of the type of therapy and early treatment in the family of patients with Lynch syndrome, which is expected to have a positive impact on economic optimization for the health ecosystem in Indonesia. In terms of medical device independence, BioColomelt-Dx has a Domestic Component Level (TKDN) of more than 50%. This proves that national independence in terms of providing medical devices can be achieved. This is a momentum for the Indonesian people, to break away from dependence on imported medical devices and will reduce the cost of examination.