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@Yardlie I'm confused. Did you sign up through 23andme Canada (or other country)? After doing a quick review of the website I don't think the BRCA test is available in the USA.

There are 35 carrier status reports. This is what is available. BRCA is not listed.

ARSACS

Agenesis of the Corpus Callosum with Peripheral Neuropathy

Autosomal Recessive Polycystic Kidney Disease

Beta Thalassemia and Related Hemoglobinopathies

Bloom Syndrome

Congenital Disorder of Glycosylation Type 1a (PMM2-CDG)

Cystic Fibrosis

D-Bifunctional Protein Deficiency

Dihydrolipoamide Dehydrogenase Deficiency

Familial Dysautonomia

Fanconi Anemia Group C

GRACILE Syndrome

Glycogen Storage Disease Type Ia

Glycogen Storage Disease Type Ib

Hereditary Fructose Intolerance

Leigh Syndrome, French Canadian Type

Limb-Girdle Muscular Dystrophy Type 2D

Limb-Girdle Muscular Dystrophy Type 2E

Limb-Girdle Muscular Dystrophy Type 2I

MCAD Deficiency

Maple Syrup Urine Disease Type 1B

Neuronal Ceroid Lipofuscinosis (CLN5-Related)

Neuronal Ceroid Lipofuscinosis (PPT1-Related)

Niemann-Pick Disease Type A

Nijmegen Breakage Syndrome

Nonsyndromic Hearing Loss and Deafness, DFNB1 (GJB2-Related)

Pendred Syndrome and DFNB4 Hearing Loss

Primary Hyperoxaluria Type 2

Rhizomelic Chondrodysplasia Punctata Type 1

Sickle Cell Anemia

Sjögren-Larsson Syndrome

Tay-Sachs Disease

Tyrosinemia Type I

Usher Syndrome Type 1F

Usher Syndrome Type 3A

Zellweger Syndrome Spectrum (PEX1-Related)

https://www.23andme.com/service/

[Plaid Pants2]

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@The Monkey on My Back wrote:

A few years ago FDA prohibited this company from doing this test. I'm surprised to see they are still at it.

This is from Medscape dated Oct 30 2015:

"...23andMe doesn't have a green light, however, to market carrier tests for other kinds of inherited conditions, such as the one for BRCA mutations. Angela Calman, the company's vice president of communications, said 23andMe is trying to chart a comeback path for more of its health tests, including those for disease risk.

"We're working very hard to figure out with the FDA what needs to be done for them to be direct to consumer," Calman told Medscape Medical News.

The higher risk represented by DTC genetic tests for conditions such as cancer and Alzheimer's disease is the sticking point. Their risk reflects not only the severity of the condition, but also a patient's possible response, which may be drastic, to test results. Those for the BRCA test might prompt a woman to undergo a double mastectomy, for example..."

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The key sentence in that article is, "but also a patient's possible response, "which may be drastic, to test results."

[Say Nay]

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@Plaid Pants2 wrote:

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@The Monkey on My Back wrote:

A few years ago FDA prohibited this company from doing this test. I'm surprised to see they are still at it.

This is from Medscape dated Oct 30 2015:

"...23andMe doesn't have a green light, however, to market carrier tests for other kinds of inherited conditions, such as the one for BRCA mutations. Angela Calman, the company's vice president of communications, said 23andMe is trying to chart a comeback path for more of its health tests, including those for disease risk.

"We're working very hard to figure out with the FDA what needs to be done for them to be direct to consumer," Calman told Medscape Medical News.

The higher risk represented by DTC genetic tests for conditions such as cancer and Alzheimer's disease is the sticking point. Their risk reflects not only the severity of the condition, but also a patient's possible response, which may be drastic, to test results. Those for the BRCA test might prompt a woman to undergo a double mastectomy, for example..."

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The key sentence in that article is, "but also a patient's possible response, "which may be drastic, to test results."

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So what. It's stil prohibited.

[Yardlie]

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@The Monkey on My Back wrote:

A few years ago FDA prohibited this company from doing this test. I'm surprised to see they are still at it.

This is from Medscape dated Oct 30 2015:

"...23andMe doesn't have a green light, however, to market carrier tests for other kinds of inherited conditions, such as the one for BRCA mutations. Angela Calman, the company's vice president of communications, said 23andMe is trying to chart a comeback path for more of its health tests, including those for disease risk.

"We're working very hard to figure out with the FDA what needs to be done for them to be direct to consumer," Calman told Medscape Medical News.

The higher risk represented by DTC genetic tests for conditions such as cancer and Alzheimer's disease is the sticking point. Their risk reflects not only the severity of the condition, but also a patient's possible response, which may be drastic, to test results. Those for the BRCA test might prompt a woman to undergo a double mastectomy, for example..."

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@The Monkey on my back ... 23andme was asked to submit proof to the FDA regarding the results of their tests. That was back in 2013, actually. This is a more current write up about it from October, 2015.:

After the Food and Drug Administration (FDA) forced 23andMe to stop marketing the health reports in its spit kits in 2013, the personal genomics company has now been approved to offer its tests directly to consumers, according to a press release posted today on the company’s website. It is the first company to have FDA approval to market genetic tests directly to consumers, without a doctor’s approval or intervention.

No doctor is going to do a double mastectomy on a woman just because of a test from 23andme. Doctors do their own genetic testing.

[Plaid Pants2]

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@The Monkey on My Back wrote:

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@Plaid Pants2 wrote:

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@The Monkey on My Back wrote:

A few years ago FDA prohibited this company from doing this test. I'm surprised to see they are still at it.

This is from Medscape dated Oct 30 2015:

"...23andMe doesn't have a green light, however, to market carrier tests for other kinds of inherited conditions, such as the one for BRCA mutations. Angela Calman, the company's vice president of communications, said 23andMe is trying to chart a comeback path for more of its health tests, including those for disease risk.

"We're working very hard to figure out with the FDA what needs to be done for them to be direct to consumer," Calman told Medscape Medical News.

The higher risk represented by DTC genetic tests for conditions such as cancer and Alzheimer's disease is the sticking point. Their risk reflects not only the severity of the condition, but also a patient's possible response, which may be drastic, to test results. Those for the BRCA test might prompt a woman to undergo a double mastectomy, for example..."

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The key sentence in that article is, "but also a patient's possible response, "which may be drastic, to test results."

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So what. It's stil prohibited.

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I'm not disagreeing.

I am, however agreeing with the article, that there WILL be those who will freak out, like the article said, to the test results.

[Say Nay]

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@Brinklii wrote:

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@The Monkey on my back ... 23andme was asked to submit proof to the FDA regarding the results of their tests. That was back in 2013, actually. This is a more current write up about it from October, 2015.:

After the Food and Drug Administration (FDA) forced 23andMe to stop marketing the health reports in its spit kits in 2013, the personal genomics company has now been approved to offer its tests directly to consumers, according to a press release posted today on the company’s website. It is the first company to have FDA approval to market genetic tests directly to consumers, without a doctor’s approval or intervention.

No doctor is going to do a double mastectomy on a woman just because of a test from 23andme. Doctors do their own genetic testing.

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Thank you for the info. Unfortunately the press release link doesn't work.

Can you please see my other question? I don't see the BRCA listed on their website. 

[Say Nay]

Another article from New Scientist dated Oct 22 2015:

"... The company is not testing for the conditions that raised the most concerns last time, such as heart attack, asthma and hip fractures, for which lifestyle factors are often more important, says Cecile Janssens an epidemiologist at Emory University in Atlanta, Georgia.

Janssens adds that the company is also refraining from testing for high-risk genetic mutations to genes such as BRCA1 and BRCA2, which are related to developing breast and ovarian cancer and to APOE, which are linked to Alzheimer’s. “It will be most interesting to follow what the FDA is going to decide for these tests,” she says..."

https://www.newscientist.com/article/dn28378-23andme-relaunches-direct-to-consumer-tests-for-genetic...

[Yardlie]

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@The Monkey on My Back wrote:

@Yardlie I'm confused. Did you sign up through 23andme Canada (or other country)? After doing a quick review of the website I don't think the BRCA test is available in the USA.

There are 35 carrier status reports. This is what is available. BRCA is not listed.

ARSACS

Agenesis of the Corpus Callosum with Peripheral Neuropathy

Autosomal Recessive Polycystic Kidney Disease

Beta Thalassemia and Related Hemoglobinopathies

Bloom Syndrome

Congenital Disorder of Glycosylation Type 1a (PMM2-CDG)

Cystic Fibrosis

D-Bifunctional Protein Deficiency

Dihydrolipoamide Dehydrogenase Deficiency

Familial Dysautonomia

Fanconi Anemia Group C

GRACILE Syndrome

Glycogen Storage Disease Type Ia

Glycogen Storage Disease Type Ib

Hereditary Fructose Intolerance

Leigh Syndrome, French Canadian Type

Limb-Girdle Muscular Dystrophy Type 2D

Limb-Girdle Muscular Dystrophy Type 2E

Limb-Girdle Muscular Dystrophy Type 2I

MCAD Deficiency

Maple Syrup Urine Disease Type 1B

Neuronal Ceroid Lipofuscinosis (CLN5-Related)

Neuronal Ceroid Lipofuscinosis (PPT1-Related)

Niemann-Pick Disease Type A

Nijmegen Breakage Syndrome

Nonsyndromic Hearing Loss and Deafness, DFNB1 (GJB2-Related)

Pendred Syndrome and DFNB4 Hearing Loss

Primary Hyperoxaluria Type 2

Rhizomelic Chondrodysplasia Punctata Type 1

Sickle Cell Anemia

Sjögren-Larsson Syndrome

Tay-Sachs Disease

Tyrosinemia Type I

Usher Syndrome Type 1F

Usher Syndrome Type 3A

Zellweger Syndrome Spectrum (PEX1-Related)

https://www.23andme.com/service/

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@The Monkey on My Back ... I did the USA version of the 23andme test. In addition to my ethnicity, I was negative for all the diseases you listed above. Once I got the results, I submitted the "raw data" page to promethease(dot)com. They want people's data for their research purposes. They only charge $5 to collect your data and have it analyzed by their computer. In return they send you a breakdown of each gene and tell you what you are at high risk for. They told me that I carry the mutated BRCA2 gene. So...I will see my doctor about this since my mother and aunt both are breast cancer survivors.

The report from Promethease also indicated a higher than normal risk for pancreatic cancer (which my youngest aunt died from at age 62) and several genes showed pootential cardiac disease problems...which definitely runs in our family.

Promethease's report is extremely technical and comprehensive. Apparently, it is thousands of pages long. There is a summary page though, and there is also a way to search for information. I have not been through it extensively yet. The BRCA2  gene mutation was at the top of my first page, because I carry an extremely high chance of getting cancer from it. I rated 6 out of a possible 6 in magnitude on that gene. Needless to say, I won't waste any time talking to my doctor and a genetic counsellor about further testing.

I'd say Promethease's test are a good thing to do if you can psychologically handle the prospective results. I consider it a screen...and now I will have professional testing.

[Say Nay]

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@Brinklii wrote:

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@The Monkey on My Back ... I did the USA version of the 23andme test. In addition to my ethnicity, I was negative for all the diseases you listed above. Once I got the results, I submitted the "raw data" page to promethease(dot)com. They want people's data for their research purposes. They only charge $5 to collect your data and have it analyzed by their computer. In return they send you a breakdown of each gene and tell you what you are at high risk for. They told me that I carry the mutated BRCA2 gene. So...I will see my doctor about this since my mother and aunt both are breast cancer survivors.

The report from Promethease also indicated a higher than normal risk for pancreatic cancer (which my youngest aunt died from at age 62) and several genes showed pootential cardiac disease problems...which definitely runs in our family.

Promethease's report is extremely technical and comprehensive. Apparently, it is thousands of pages long. There is a summary page though, and there is also a way to search for information. I have not been through it extensively yet. The BRCA2  gene mutation was at the top of my first page, because I carry an extremely high chance of getting cancer from it. I rated 6 out of a possible 6 in magnitude on that gene. Needless to say, I won't waste any time talking to my doctor and a genetic counsellor about further testing.

I'd say Promethease's test are a good thing to do if you can psychologically handle the prospective results. I consider it a screen...and now I will have professional testing.

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Ah, okay. So this is a different company. Interesting. So 23andme found a way to get around the FDA "marketing" restriction by utilizing another company (or maybe a subsidiary of their company under another name).

To clarify Promethease is a "literature retrieval system that builds a personal DNA report based on connecting a file of DNA genotypes to the scientific findings cited in SNPedia."

They do not test DNA. 

[Say Nay]

In order to get the results from Promethease one needs to  agree to tthe following:

"Before you may use Promethease to retrieve information about the human genome, you must read and agree to the following statements. Please read each statement and check the box next to each one and then click 'I Agree':

	1) I understand that the information provided in my Promethease report is based on SNPedia.com and that my report is for educational and research purposes only.
	2) I understand that my report is deleted after 45 days but that I can download it before it is deleted.
	3) I realize that most published reports about DNA variations explain only a small part of the heritability of a trait, and they also don't take into account how different variants might interact. In addition, published reports typically ignore environmental, dietary, microbial, medical history and lifestyle factors, any or all of which may well affect my true risk for any trait or disease.
	4) I am aware that I am strongly encouraged to discuss my Promethease report with a doctor, genetic counselor or other health-care provider prior to making any medical or reproductive decisions. I also acknowledge that I am advised to confirm any significant finding discovered in part through the use of Promethease by an independent, clinically validated test for use in connection with the medical trait in question.
	5) I have read and understand the Privacy Policy and the Legal Terms and Conditions of this website. I agree to these conditions."