Amid concerns over gene mutations going undetected due to the variety of medical devices and test reagents in use, a Japanese organization has drawn up guidelines for standard procedures and frameworks to ensure that genetic tests are reliable.

The Japanese Committee for Clinical Laboratory Standards published the guidelines after studying international standards as well as guidelines and articles at home and abroad. The guidelines stipulate what staff are required, the records that need to be kept and the correct way to check instruments and reagents.

JCCLS consists of representatives from companies and academic societies with a focus on disease diagnosis and treatment.

The guidelines also call for hospitals and other medical facilities analyzing test results to compare the results with those from other institutions to ensure precision.

The move comes as an increasing number of people are opting to have their genes checked on being diagnosed with an intractable disease or in order to select an appropriate cancer treatment.

In collaboration with the committee, the Japan Accreditation Board, which evaluates abidance to international standards across various fields, has launched work to recognize institutions that carry out genetic testing in line with the new guidelines.

Accreditation is subject to passing on-site investigations and practical exams.

"Producing a correct result is key to safe, secure medicine," said Hayato Miyachi, a Tokai University professor who is involved in crafting the guidelines. "I believe the guideline will play a major role."

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Organization crafts genetic testing guidelines to ensure reliability - Japan Today

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