FDA Approves Foundation Medicine's FoundationOne®Liquid CDx, a Comprehensive Pan-Tumor Liquid Biopsy Test for Patients with Advanced Cancer

[cujoe]

Good News for PCa patients with advanced disease and on Medicare/Medicaid. This expands the coverage to genetic testing for all solid tumors using blood samples alone.

From the Foundation Medicine Press Release:

"From a clinical perspective, I believe physicians should discuss tumor genomic profiling with every metastatic prostate cancer patient to inform the use of targeted and immunotherapies," said Neeraj Agarwal, M.D., Director of the Genitourinary Oncology Program and Professor of Medicine at the Huntsman Cancer Institute, Salt Lake City, Utah. "This approval addresses the need for blood-based genomic testing options when tissue can be challenging to obtain."

And

“All patients should have access to high-quality genomic insights about what is driving their tumor to help inform personalized treatment planning,” said Andrea Ferris, President and Chief Executive Officer of LUNGevity Foundation. “For many patients, getting a tissue biopsy is not an option due to tumor location or the patient’s health status, or a patient may simply prefer not to have an additional procedure. Blood-based biomarker testing options can help to expand access to these actionable genomic insights in patients with advanced cancer.”

Link to Full Press Release:

foundationmedicine.com/pres...

Knowledge is Power. Stay Safe - Captain K9

[cesces]

So it appears it doesn't test for cancer, but for genes. Especially those genes indicating likely success with a handful of treatments.

"Using a blood sample, FoundationOne Liquid CDx analyzes over 300 cancer-related genes for alterations. FoundationOne Liquid CDx results are delivered in an integrated report that identifies alterations matched to FDA-approved therapies and, within its professional services section, delivers information about the genomic signatures microsatellite instability and blood tumor mutational burden, as well as single gene alterations, including all NTRK fusions, to help inform the use of other therapies including immunotherapies. The report also provides relevant clinical trial information and includes interpretive content developed in accordance with professional guidelines in oncology for patients with any solid tumor.

FoundationOne Liquid CDx is indicated for use as a companion diagnostic for four FDA-approved precision therapies, including an indication for Rubraca (rucaparib), a PARP inhibitor approved by the FDA for treatment of metastatic castration-resistant prostate cancer patients with BRCA1/2 mutations, and three first-line EGFR-TKIs for the treatment of non-small cell lung cancer patients."

[cujoe in reply to cesces]

I had the good fortune to get similar genetic testing via the STRATA clinical trial. That was/is similar to the Foundation One and tested for about 120 various genetic defects. (Foundataion One tests for over 300.) At the time of my testing, STRATA tested in five categories: Hotspot mutations, Hotspot mutation or deleterious mutation, Gene amplification, Deep gene deletion, & Gene fusion. Many specific genes show up in several defect categories.

Like FoundationOne, STRATA is a "matching" service: i.e., it potentially matches your genetic profile to clinical trials and available drugs that have been show to work against certain genetic defects. FoundationOne provides a detailed report indicating the current drugs that have evidence of working for your specific genetic defects. That would include drugs that are not currently in use for PCa, but would be potential candidates for off-label use. Apparently they maintain and provide access to an updated database of such "matches". Nalakrats has spoken very highly of how helpful their staff is in responding to phone call questions before, during, and after testing.

In my case, I was fortunate to have no defects, so I have no idea what STRATA would have provided to me had defects been detected. It is also significant that the analysis was done on 4 year-old tissue from my final biopsy (2013 RALP), so there is also the possibility for somatic gene changes in the interim years. (The test was done in 2017 and I had 8 weeks of IMRT and one 3-mo round of ADT in those four years prior to the testing.)

The reason my MO was likely able to get me into the trial, is that cancer is the cause of death for both my parents and two of my siblings. Finding no defects was a major surprise to me, my MO, and my family. It also gave me the confidence to go on my extended treatment vacation that is now at three years and counting; i.e., knowledge is power - and the more you have, the better the decisions you can make.

Here is a short video that explains FoundationOne's testing approach:

youtube.com/watch?v=vRTZJlC...(Not working as expected?)

Definitely not a silver bullet solution, but it might provide the information that would get you to the most effective treatment in timely fashion. The unknown (by me) is how Medicare approval for this will affect the coverage and cost to those on other forms of health insurance. Hopefully, it will make it more accessible and at a reasonable cost. If not, it provides one more example why a Medicare-For-All health care option would be a good thing for 99% of cancer patients.

Stay Safe & Well - K9