DNA Collection Kit

2018: Entry into the market

At the beginning of March, 2018 the first genetic test for predisposition to a breast cancer which can use in house conditions is announced, without seeing a doctor. The product under the name DNA Collection Kit developed by company 23andMe is intended for identification of three mutations of genes of BRCA1 and BRCA2, the connected som risk of development not only a breast cancer, but also ovarian cancer or a prostate gland.

In March, 2018 the American Department on control of medicines and foodstuff (FDA) approved this test to use though several years ago the regulator extremely carefully belonged to house genetic tests such, in view of neighboring risks.

The DNA house test for predisposition to a breast cancer from company 23andMe

The false positive test result on predisposition to a breast cancer leads to carrying out unjustified inspections, chemoprophylaxis or surgeries. At the same time the false-negative result reduces the patient's onkonastorozhennost even if the risk of development of cancer is quite real, – the letter of FDA of May 23, 2013 said.

Paid special attention of FDA to the test for diagnostics of mutations of genes of BRCA as its results give the grounds to doctors to appoint serious preventive and medical interventions, including operational.

So far it is not clear what caused such change of policy, however having even approved house diagnostic test of company 23andme, FDA set a set of restrictions. So, for example, the test was approved only for identification of three mutations of BRCA. There are more than one thousand options of mutations of this gene which potentially increase risk of development of a breast cancer and other localizations, and these three options do not even concern the most widespread of them.

In the appeal of FDA it is highlighted that results of diagnostic test are not comprehensive, and the negative result does not guarantee lack of other mutations of a gene causing cancer. Besides, house genetic test it is impossible to use establishments of the diagnosis and purpose of treatment without carrying out other researches and genetic consultation.^[1]

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