The US federal government has proposed a standard method to ensure the accuracy of DNA testing when patients customize individualized treatments. It can be said that this opens the door to a new era of genetic medicine.

Scientists have now identified hundreds of genetic mutations that may increase the risk of specific diseases, including cancer, Alzheimer's disease, cystic fibrosis, and more. However, due to differences in testing equipment and methods between different laboratories, they often report different results when analyzing genes extracted from the same blood or tissue sample.

The National Institute of Standards and Technology announced on Thursday that it has developed "benchmarking materials" that labs can use to determine whether their instruments and software can correctly analyze a person's genetics. Blueprint, also known as the genome.

The Institute promotes benchmark materials to thousands of products such as steel, cement and peanut butter, and uses them to achieve a variety of purposes, such as calibrating instruments, ensuring building safety, and ensuring the accuracy of nutrition labels.

Labs can use this new DNA standard to ensure the accuracy of their genetic testing. If the laboratory produces a "correct answer" when testing the baseline material—for example, if the same mutation is found at the same site, then they can be considered to have similar accuracy when testing patient samples.

In the laboratory, the equipment that undertakes this type of work is called a DNA sequencer. With it, scientists can accurately locate mutations and tailor individualized treatments to the individual genetic characteristics of patients, greatly promoting biomedicine. Research and discovery. Although such tests and treatments were born in research laboratories, they quickly entered the field of medical practice.

In this year's State of the Union, President Obama announced a "precise medical plans (precision medicine initiative)", aims to promote the development and application of such customized therapies.

The benchmark is sold on the website of the National Standards Institute, a unit of the US Department of Commerce. Now, scientists and labs can buy a small bottle for $450, including one from Utah. 10 micrograms of DNA from a woman of European descent is sufficient for multiple tests.

“If you send a blood or tumor biopsy sample to a different genetic testing laboratory, you may get different results,” said Marc L. Salit, head of the Institute's genome measurement team. )Say. “Although they are generally consistent, there may still be significant differences. Now, for the first time, we have a (unified) standard that can check the quality and reliability of gene sequencing .”

Dr. Salit said that the laboratory can use the sample to prove the quality of their work, and the health insurance company will have more confidence in the test results and the possibility of paying for genome sequencing tests. He added that although the cost of sequencing has declined in recent years, genome-wide analysis and interpretation still cost around $5,000.

The Food and Drug Administration (FDA) geneticist Elizabeth A. Mansfield is responsible for regulating individualized medicine, and she said benchmark materials will "improve instruments. And testing". In this way, “the health plan will be more willing to pay for such tests.”

Developed in collaboration with the FDA and the Standards Institute, the DNA benchmark material also gives regulators a new tool for assessing test accuracy.

Jeffrey E. Shuren, director of the FDA Center for Devices and Radiological Health, said: "Inaccurate genome sequencing tests can lead to patients being misdiagnosed and accepting errors. Treatment is not treated at the time of effective treatment." He added that the accuracy of genetic testing is becoming increasingly important as treatments are increasingly based on the types of mutations found in genetic testing. .

Dr. Francis S. Collins, dean of the National Institutes of Health, said that the information obtained in genetic testing can help patients in many ways. “For example, oncologists can use sequencing results to select the chemotherapy drugs that may be the best.”

The regulation of DNA detection and its technology is very complicated and has changed.

Under the 1988 law, Centers for Medicare and Medicaid Services is responsible for the management and certification of clinical laboratories. The sister agency FDA, which is part of the same department as the agency, oversees the manufacturer and the tests that have been applied. The FDA has traditionally not enforced some of its requirements for “laboratory testing” (including many genetic tests), but the agency proposed last year that it should rectify and strengthen the regulation of these products.

The new benchmark material is suitable for the analysis of individual DNA detection using advanced "next generation sequencing" technology. The results of such tests are usually not sold directly to consumers, but need to be interpreted by a doctor or genetic counselor.

In 2013, the FDA notified Silicon Valley's 23andMe Company to suspend sales of health reports containing interpreted personal DNA information. In February, the agency approved the company to provide a direct-to-consumer test to help identify carriers of genes linked to a particular rare disease, Bloom syndrome.

The FDA expects a new wave of human genome analysis to emerge and provides partial funding for the work of scientists and engineers at the Gaithersburg City Standards Institute in Maryland.

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