The U.S. Food and Drug Administration has straighten out 23andMe to betray directly to customers a DNA test for gene mutations linked to boob cancer , progress to it the first consumer DNA examination troupe to succeed the federal agency ’s approval for a cancer risk screening .
The new mental testing will analyse DNA for three specific BRCA1 and BRCA2 breast cancer gene chromosomal mutation . Though there are more than 1,000 known BRCA mutation , the 23andMe test will focalize on three mutations most common in citizenry of Ashkenazi Jewish descent . The variants are far less vulgar in other population .
Shirley Wu , 23andMe ’s managing director of product science , told Gizmodo that the company focus on those three mutations because of the all-inclusive body of scientific literature back up their radio link to Crab , and hopes to eventually offer trial for other potentially harmful variance .
Illustration: Joe Tonelli/Gizmodo
“ This test offers high value to consumers , ” Wu enjoin . “ The scientific hardiness is clean-cut cut . ”
study hint that some 1 in 40 people of Ashkenazi descent has one of these three stochastic variable , Wu enunciate , and women with one of the variants have a 45 percentage to 85 percent hazard of originate breast cancer by years 70 . The factor also suggest a higher risk of exposure of ovarian cancer in womanhood , and breast cancer in men .
“ Traditionally you only would get test for BRCA if you have a category history of cancer ” sound out Wu . “ We are providing a psychometric test people at risk of exposure that otherwise would have been missed . This is a giant step onward for consumers in render them direct access . ”
Eric Topol , a geneticist at the Scripps Institute , was more tempered in his ebullience .
“ This is very limited information on three mutations that are make love to be pathogenic for BRCA , ” he distinguish Gizmodo .
He said that more comprehensive but still cheap test by troupe likeColoroffer a more perfect motion picture of risk . The difference , though , is that Color ’s test must be ordered by a Dr. .
“ Those test can get the false illusion that they are not letter carrier , when in fact they may have other of 100 of have sex functional variation , ” Topol said . “ The newfangled offering by 23andMe is good than nothing , but we need to ( and can ) do far well . ”
The FDA , in itsannouncement of the intelligence , also note that most cases of Crab are not induce by familial gene mutations . And aNational Cancer Institute subject , albeit one from 1997 , found less prevalence of the mutation among women of Ashkenazi decent , detecting it in only 2 percent of Ashkenazi Judaic people .
Still , at $ 199 , the trial run offers an inexpensive option to try out through a Doctor of the Church ’s office , which can end up costingthousands of dollar . And , as Wu pointed out , doc more often than not do not paint a picture testing mass without a family history that indicates the presence of a harmful mutation , though many woman develop cancer despite a lack of family history of the disease , or do not recognise their family account .
Originally , 23andMe offered assessments for more than 250 disease and conditions , but in 2013 the FDAcracked downand rank the company to cease providing analysis of mass ’s hazard divisor for disease until the tests ’ accuracy could be validated . Then last April , the FDA yield the company the go - ahead to market test for 10 diseases or conditions right away to consumers . The company presently offers psychometric test that assess the health jeopardy of develop disease including Alzheimer ’s , Parkinson ’s , and celiac , but the new psychometric test will be the companionship ’s first to assess cancer risk . The ship’s company said that existing customers will have approach to results for this trial in the coming weeks .
Last fall , the FDA also annunciate that it was clearing the way for consumer health DNA trial run tomake it to grocery store faster , without a pre - market review , but test to assess Cancer the Crab hazard were not included in that exemption . In its review , the FDA examined 23andMe ’s data to ensure that the mental test is accurate and can furnish consistent results , as well as reviewing the report card to assure that they can be easy understand by a consumer .
This mental testing is potential just the first of many Cancer the Crab risk examine that 23andMe will roll out in the futurity .
CancerDNA TestingGeneticsScience
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