On 2016 May 31, David Keller commented:

None

On 2016 May 30, David Keller commented:

My ColoGuard cancer screening was reported as "negative" in April, 2016. I immediately requested the results of two tests done as part of the ColoGuard screening algorithm, specifically my fecal hemoglobin concentration, and my ColoGuard Composite Score [of colon cancer risk]. These are important tests with easily interpreted results, which every patient's physician should review.

Exact Sciences, the manufacturer and retail seller of Cologuard screening tests, stated that the test results I requested cannot be reported due to FDA regulations, which require stand-alone approval of all tests, even those used as part of an approved screening kit. The test results I requested, although conveying unique, accurate and medically important information, thus cannot be reported to the patient or his doctor, even if severely abnormal results are found.

Patients have an ethical right to demand all of their test results, even for tests which are performed without specific FDA approval, but as part of an FDA-approved algorithm of tests.

The regulations being enforced at this time will lead to avoidable patient harms, and must be revised to mandate patient access to the results of all medical tests performed on them.

On 2016 May 29, David Keller commented:

Please see the final version of my article, which is published online above. I posted it here temporarily during a dispute with an affected commercial entity.

On 2016 May 29, David Keller commented:

Additional comments and suggestions related to MultiTarget fecal testing"

The MultiTarget composite score can be negative for colon neoplasia despite an elevated fecal hemoglobin concentration consistent with another disorder.[1] In such cases, FDA regulations prohibit release of any MultiTarget test data except whether the overall screening test was positive or negative for colon neoplasia.[2]

I screened myself with the MultiTarget screening method because it is more sensitive and has a smaller false negative rate than FIT screening, leading to fewer missed cancers. I intend to screen myself again with MultiTarget the next time I am eligible for full Medicare reimbursement in 3 years. The down side is that MultiTarget has a lower specificity and a higher false positive rate than FIT, resulting in more unnecessary colonoscopies with MultiTarget; this is a trade-off I chose to accept. Because Medicare (with a standard Medigap policy) pays for MultiTarget screening in full, its higher cost than FIT was not an issue for me.

Additionally, I will screen annually with a FIT test, to detect occult fecal hemoglobin elevations not reported by MultiTarget. Performing FIT testing in parallel with MultiTarget testing in this way will result in even higher sensitivity and lower specificity, but less so than predicted by the "parallel testing" formula, since these two tests are not completely independent.

I have written to the FDA requesting them to allow the makers of MultiTarget to release all the intermediary data generated by their test, including the patient's composite score, fecal hemoglobin and all DNA test results. It is not ethical or in the public interest for the FDA to refuse to allow patients or their physicians to have access to this data, in my opinion.

References

1: Keller DL, Patients Should Not Be Denied Access to Their Test Results, online publication, temporarily removed, American Journal of Medicine, May 2016

2: Telephone discussion with MultiTarget laboratory director, May 2016

On 2016 May 29, David Keller commented:

Additional comments and suggestions related to MultiTarget fecal testing"

The MultiTarget composite score can be negative for colon neoplasia despite an elevated fecal hemoglobin concentration consistent with another disorder.[1] In such cases, FDA regulations prohibit release of any MultiTarget test data except whether the overall screening test was positive or negative for colon neoplasia.[2]

I screened myself with the MultiTarget screening method because it is more sensitive and has a smaller false negative rate than FIT screening, leading to fewer missed cancers. I intend to screen myself again with MultiTarget the next time I am eligible for full Medicare reimbursement in 3 years. The down side is that MultiTarget has a lower specificity and a higher false positive rate than FIT, resulting in more unnecessary colonoscopies with MultiTarget; this is a trade-off I chose to accept. Because Medicare (with a standard Medigap policy) pays for MultiTarget screening in full, its higher cost than FIT was not an issue for me.

Additionally, I will screen annually with a FIT test, to detect occult fecal hemoglobin elevations not reported by MultiTarget. Performing FIT testing in parallel with MultiTarget testing in this way will result in even higher sensitivity and lower specificity, but less so than predicted by the "parallel testing" formula, since these two tests are not completely independent.

I have written to the FDA requesting them to allow the makers of MultiTarget to release all the intermediary data generated by their test, including the patient's composite score, fecal hemoglobin and all DNA test results. It is not ethical or in the public interest for the FDA to refuse to allow patients or their physicians to have access to this data, in my opinion.

References

1: Keller DL, Patients Should Not Be Denied Access to Their Test Results, online publication, temporarily removed, American Journal of Medicine, May 2016

2: Telephone discussion with MultiTarget laboratory director, May 2016

On 2016 May 29, David Keller commented:

Please see the final version of my article, which is published online above. I posted it here temporarily during a dispute with an affected commercial entity.

On 2016 May 30, David Keller commented:

My ColoGuard cancer screening was reported as "negative" in April, 2016. I immediately requested the results of two tests done as part of the ColoGuard screening algorithm, specifically my fecal hemoglobin concentration, and my ColoGuard Composite Score [of colon cancer risk]. These are important tests with easily interpreted results, which every patient's physician should review.

Exact Sciences, the manufacturer and retail seller of Cologuard screening tests, stated that the test results I requested cannot be reported due to FDA regulations, which require stand-alone approval of all tests, even those used as part of an approved screening kit. The test results I requested, although conveying unique, accurate and medically important information, thus cannot be reported to the patient or his doctor, even if severely abnormal results are found.

Patients have an ethical right to demand all of their test results, even for tests which are performed without specific FDA approval, but as part of an FDA-approved algorithm of tests.

The regulations being enforced at this time will lead to avoidable patient harms, and must be revised to mandate patient access to the results of all medical tests performed on them.

On 2016 May 31, David Keller commented:

None