Recognition of ‘safety and effectiveness’ of new medical technology such as quantitative test for nonalcoholic fatty liver

Korea Institute of Health and Medical Sciences CI [사진= 한국보건의료연구원 제공]
Quantitative tests for nonalcoholic fatty liver disease and oral and maxillofacial bone graft were approved as new medical technologies.

The Korea Health and Medical Research Institute announced on the 16th that the 4 new medical technologies that were finally reviewed as safe and effective medical technologies at the 5th Medical Technology Evaluation Committee of the Ministry of Health and Welfare in 2021 were announced.

Since its introduction in 2007 to evaluate the safety and clinical usefulness of new medical technology, the new medical technology evaluation system has been implemented to prevent the indiscriminate use of unverified medical technology and to protect the public’s right to health.

New medical technology recognized this time includes quantitative test of hepatic steatosis in nonalcoholic fatty liver disease using controlled attenuation parameters.
It is a technology that quantitatively measures the fat in the liver using ultrasound in patients with nonalcoholic fatty liver. It is non-invasive and has an acceptable level of diagnostic accuracy compared to liver biopsy. It has been evaluated as a safe and effective technique to check the fatty liver level (CAP) to evaluate liver status and establish a treatment plan.

Selective infusion of donor lymphocytes from which naive T-cells were removed was also approved. This is a technology that treats infections by removing specific specific antigen-positive cells (Naive T cells, CD45RA+) from the donor and injecting them into the patient after allogeneic hematopoietic stem cell transplantation, targeting patients with severe viral infection who do not respond to antiviral treatment. The incidence of graft-versus-host reaction was similar to that of the patient group who did not receive this procedure, and no side effects or complications were reported. There is no alternative treatment for severe viral infection after transplantation, and a single-arm study showed that severe viral infection was cured.

Oral and maxillofacial bone grafting, that is, autologous tooth-derived bone grafting, is a technology that processes and transplants bone derived from extracted autologous teeth in the area of ​​the hard tissue of the oral and maxillofacial area that has been deficient or degenerated. Safety was evaluated because there were no bone graft-related complications, and compared to existing bone graft materials, it showed similar efficacy in new bone formation and bone growth indicators.

The PIK3CA companion diagnostic test is a technology that detects mutations in the PIK3CA gene in DNA extracted from tumor tissue or plasma of breast cancer patients using the real-time polymerase chain reaction method, and selects patients for prescription target therapy with Alperisip. This is an in vitro test, and the degree of response and progression-free survival according to Alperisip treatment were reported to be higher than in the placebo group. It was evaluated as a safe and effective technology.

Reporter Kim Seong-eun [email protected]

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