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FGC Corp
07-26-2016, 03:01 AM
I have been looking into offering a cancer test for about $400 (30 genes). Do you think there would be demand among the community? The reason for the pricing is this would be a medical quality test, and would have medical quality data and reports. (in order to achieve medical quality reports, there are expenses associated with maintaining high quality data and high quality clinical reports).

Unlike our whole genome offering, this offering would include medical quality cancer assessments. The accuracy would be 99.99%, Secondly, ordering the test in the US would require a doctor's prescription.

An exome test is not as accurate or reliable as this test. For cancer tests results, 99.99% reliability is the goal.

For example, the SNP chips used by 23andme, FTDNA, and Ancestry.com are 99.5% accurate. For medical results this test would achieve 99.99% accuracy.

Cancers covered:
breast cancer
ovarian cancer
uterine cancer
colorectal cancer
melanoma
pancreatic
stomach
prostate

FGC Corp
07-26-2016, 03:06 AM
If you are interested contact us at: sales [at] fullgenomes.com

AnnieD
07-26-2016, 04:55 AM
Interested ... will consult budget. :) Would this be structured similar to 23andMe as a one-time fee with automatic updates if future advancements are made?

FGC Corp
07-26-2016, 05:09 AM
Interested ... will consult budget. :) Would this be structured similar to 23andMe as a one-time fee with automatic updates if future advancements are made?

This would be a one-time report, just like getting a blood test. The next step in the future might be to take an upgraded panel. As the costs come down these medical panels will cover more genes.

Afshar
07-26-2016, 05:47 AM
The danger with offering this test is you will miss on some new(ly discovered) genes that are also involved in those processes and you declare the patient "cancer-proof", need to have a really tight disclaimer.

FGC Corp
07-26-2016, 07:09 AM
The danger with offering this test is you will miss on some new(ly discovered) genes that are also involved in those processes and you declare the patient "cancer-proof", need to have a really tight disclaimer.

Medical knowledge is always improving. However, I would like to know useful information today, rather than wait indefinitely as knowledge continues to improve.

It is a trade-off, but, for example BRCA1 and BRAC2 are very significant contributors to cancer risk, as are the others. But, like any medical test, it should be interpreted very carefully.

Afshar
07-26-2016, 07:14 AM
Medical knowledge is always improving. However, I would like to know useful information today, rather than wait indefinitely as knowledge continues to improve.

It is a trade-off, but, for example BRCA1 and BRAC2 are very significant contributors to cancer risk, as are the others. But, like any medical test, it should be interpreted very carefully.
Yes, the BRCAs would be a nice start (together with TP53 and CHEK2) for breast cancer indications).

bfcockburn
07-26-2016, 03:17 PM
Certainly there would be a market for such as test, which could easily be extended to other genetically caused conditions and diseases. But I would be very cautious about protecting the company against legal action from customers who misinterpret their results. Limiting the service to patients who are ordering the tests via a qualified doctor would be a good place to start. I would carefully study 23AndMe's experiences with the FDA.

FGC Corp
07-26-2016, 04:28 PM
Certainly there would be a market for such as test, which could easily be extended to other genetically caused conditions and diseases. But I would be very cautious about protecting the company against legal action from customers who misinterpret their results. Limiting the service to patients who are ordering the tests via a qualified doctor would be a good place to start. I would carefully study 23AndMe's experiences with the FDA.

The model would be to have the customer's doctor interpret the reports. We would also have genetic counselors available as well.

FGC Corp
07-31-2016, 09:36 PM
FYI

"Another 2014 study found that although 75 percent of Americans were aware of Jolie Pitt’s announcement and surgery, less than 10 percent of the respondents fully understood how the BRCA gene affected her risk for the disease."

http://www.huffingtonpost.com/entry/after-angelina-jolie-pitts-double-mastectomy-breast-surgery-awareness-rises_us_56093f62e4b0dd85030813a3

This may suggest that the market is not yet ready for this type of test.

Star93
07-31-2016, 10:30 PM
There will definitely be high demand for such tests, not only for cancer but for other medical conditions as well. Customers would expect highly informative and personalised reports rather than the vague explanations currently offered by 23andme.

miiser
08-01-2016, 01:00 AM
I have been looking into offering a cancer test for about $400 (30 genes). Do you think there would be demand among the community? The reason for the pricing is this would be a medical quality test, and would have medical quality data and reports. (in order to achieve medical quality reports, there are expenses associated with maintaining high quality data and high quality clinical reports).

Unlike our whole genome offering, this offering would include medical quality cancer assessments. The accuracy would be 99.99%, Secondly, ordering the test in the US would require a doctor's prescription.

An exome test is not as accurate or reliable as this test. For cancer tests results, 99.99% reliability is the goal.

For example, the SNP chips used by 23andme, FTDNA, and Ancestry.com are 99.5% accurate. For medical results this test would achieve 99.99% accuracy.

Cancers covered:
breast cancer
ovarian cancer
uterine cancer
colorectal cancer
melanoma
pancreatic
stomach
prostate

As someone with medical device experience, I just want to warn you to make sure you've considered the FDA regulatory implications of this. Getting FDA approval for such tests can be a costly process, requiring expertise that you may not already have in house.

I do think it's a good idea though. I think in 10 or 15 years, doctors will order genetic testing as a routine blood test, and insurance companies will happily cover such testing as a cost saving preventative test.

Just be sure you've got the required investment funding to make it through all the FDA hurdles. This probably isn't something you can do out of a lab in someone's garage. If it's a challenge for the wife of a Google executive to pull off, it may be near impossible for a small independent startup.

Regarding Angelina Jolie Pitt's surgery - I think this event, and the likelihood for ensuing public health quackery, is what triggered the FDA crack down on 23andMe.

Gravetto-Danubian
08-01-2016, 01:03 AM
Hhhmm
Aren't most cancers (>90%) sporadic & cumulative mutations .
So I'm not sure how efficacious and beneficial such a "screening" test will be

miiser
08-01-2016, 01:34 AM
Hhhmm
Aren't most cancers (>90%) sporadic & cumulative mutations .
So I'm not sure how efficacious and beneficial such a "screening" test will be

Genetic testing just gives an estimate for an individual's risk of developing various cancer types. But some individuals have such a high genetic risk that it warrants more frequent or more aggressive screening for the appearance of cancer. The genetic profile can inform subsequent testing. It's similar to the doctor having you fill out forms of your family history, just a more modern, potentially more precise approach.

Gravetto-Danubian
08-01-2016, 02:21 AM
Genetic testing just gives an estimate for an individual's risk of developing various cancer types. But some individuals have such a high genetic risk that it warrants more frequent or more aggressive screening for the appearance of cancer. The genetic profile can inform subsequent testing. It's similar to the doctor having you fill out forms of your family history, just a more modern, potentially more precise approach.

Thanks, I'm aware of that
But if a low pre-test probabilities, and lack of specific selective criteria for screening, I'd be guarded as to what it really offers
How clinically relevant would it be ?

FGC Corp
08-01-2016, 02:48 AM
As someone with medical device experience, I just want to warn you to make sure you've considered the FDA regulatory implications of this. Getting FDA approval for such tests can be a costly process, requiring expertise that you may not already have in house.

I do think it's a good idea though. I think in 10 or 15 years, doctors will order genetic testing as a routine blood test, and insurance companies will happily cover such testing as a cost saving preventative test.

Just be sure you've got the required investment funding to make it through all the FDA hurdles. This probably isn't something you can do out of a lab in someone's garage. If it's a challenge for the wife of a Google executive to pull off, it may be near impossible for a small independent startup.

Regarding Angelina Jolie Pitt's surgery - I think this event, and the likelihood for ensuing public health quackery, is what triggered the FDA crack down on 23andMe.

We'd use the off-the-shelf model and collaborate with an existing lab using a test that has already been approved.

FGC Corp
08-01-2016, 09:29 PM
Another item:


Article:

"Cancer research is important and should, of course, go on. But let's not kid ourselves that it's been cost-effective, because by almost any definition, it hasn't been. Since President Nixon declared a War on Cancer in 1971, we've dumped $500 billion into the conflict—and the cancer death rate has hardly budged. "



Link: Article:

"Cancer research is important and should, of course, go on. But let's not kid ourselves that it's been cost-effective, because by almost any definition, it hasn't been. Since President Nixon declared a War on Cancer in 1971, we've dumped $500 billion into the conflict—and the cancer death rate has hardly budged. "

http://bigthink.com/devil-in-the-data/the-never-ending-war-on-cancer

FGC Corp
08-02-2016, 01:52 AM
Assuming this table is accurate: 1/7 or 14% of Americans die of cancer:

Percent of people who die from cancer:
https://www.flmnh.ufl.edu/fish/isaf/what-are-odds/risks-comparison/risk-death/

FGC Corp
08-02-2016, 02:09 AM
Assuming this table is accurate: 1/7 or 14% of Americans die of cancer:

Percent of people who die from cancer:
https://www.flmnh.ufl.edu/fish/isaf/what-are-odds/risks-comparison/risk-death/

Correction:
22% for men
19% for women

Ref:
http://www.cancer.org/cancer/cancerbasics/lifetime-probability-of-developing-or-dying-from-cancer

AnnieD
08-02-2016, 04:51 AM
Would you know if your company's mission & testing guidelines are aligned with the ASCO as stated on the Cancer.Net website? This website has an informative section on genetic testing for cancer risk and referenced a recent (May 2016) endorsement by the Cancer.Net Editorial Board (http://www.cancer.net/about-us).

ASCO recommends considering genetic testing in the following cases:



You have a personal or family history that suggests a genetic cause of cancer
The test can clearly show a specific genetic change
Results help with diagnosis or management of the genetic condition or cancer(s). For example, you may choose steps to lower your risk. Steps may include surgery, medication (http://www.cancer.net/node/24973), frequent screening, or lifestyle changes


"In addition, ASCO recommends genetic counseling before and after genetic testing. Learn more about ASCO's latest recommendations on genetic testing for cancer susceptibility (http://www.asco.org/asco-in-action/asco-releases-updated-policy-statement-genetic-and-genomic-testing-cancer)."

FGC Corp
08-02-2016, 04:53 AM
Would you know if your company's mission & testing guidelines are aligned with the ASCO as stated on the Cancer.Net website? This website has an informative section on genetic testing for cancer risk and referenced a recent (May 2016) endorsement by the Cancer.Net Editorial Board (http://www.cancer.net/about-us).

ASCO recommends considering genetic testing in the following cases:



You have a personal or family history that suggests a genetic cause of cancer
The test can clearly show a specific genetic change
Results help with diagnosis or management of the genetic condition or cancer(s). For example, you may choose steps to lower your risk. Steps may include surgery, medication (http://www.cancer.net/node/24973), frequent screening, or lifestyle changes


"In addition, ASCO recommends genetic counseling before and after genetic testing. Learn more about ASCO's latest recommendations on genetic testing for cancer susceptibility (http://www.asco.org/asco-in-action/asco-releases-updated-policy-statement-genetic-and-genomic-testing-cancer)."

The concept is to adapt an existing test offered in a medical setting, i.e. FDA-approved and use it in compliance with that. At the moment, the market doesn't seem compelling (nor the regulations).