tumor assay for chemo sensitivity

LaundryQueen
LaundryQueen Member Posts: 676
Just wondering if anyone has had the chemo sensitivity on their tumor done and if so, approx. when that was done and what the outcome was.

One oncologist offered that to me as an option while another said that Medicare stopped paying for it when it didn't seem to be reliable so he didn't see any point in doing it.

I understand that there are different types of tumor assays also. I had malignant cells sent to a lab in Germany (done independent of the oncologists) and the assay showed that the cells were responsive to platinum chemo and taxol and my experience with those two agents showed that to be true.

Thanks.

Comments

  • Tethys41
    Tethys41 Member Posts: 1,376 Member
    Tumor Assay
    My gyn/onc had this test done on the tumors removed during surgery. The assay indicated that the traditional drugs, carboplatin/taxol, would not be very effective. He started me on a non-traditional treatment with Gemzar/taxotere. After the first round, my CA-125 dropped very little, and it didn't touch the excessive ascites I was experiencing. I did some research and learned that most gyn/onc's don't rely on these assays for first line treatment. I requested that my treatment be changed to traditional first line drugs. The doctor agreed and added Avastin to the mix. My CA-125 dropped to almost half after the first dose of these drugs.

    I also sent off some blood to Biofocus, in Germany, a few months after completing chemo. My naturopath said they could test the cancer cells for sensitivities to chemo as well as integrative therapies, such as IV vitamin C. The results, however, were inconclusive because they could not find any cancer cells in my blood.
  • LaundryQueen
    LaundryQueen Member Posts: 676
    Tethys41 said:

    Tumor Assay
    My gyn/onc had this test done on the tumors removed during surgery. The assay indicated that the traditional drugs, carboplatin/taxol, would not be very effective. He started me on a non-traditional treatment with Gemzar/taxotere. After the first round, my CA-125 dropped very little, and it didn't touch the excessive ascites I was experiencing. I did some research and learned that most gyn/onc's don't rely on these assays for first line treatment. I requested that my treatment be changed to traditional first line drugs. The doctor agreed and added Avastin to the mix. My CA-125 dropped to almost half after the first dose of these drugs.

    I also sent off some blood to Biofocus, in Germany, a few months after completing chemo. My naturopath said they could test the cancer cells for sensitivities to chemo as well as integrative therapies, such as IV vitamin C. The results, however, were inconclusive because they could not find any cancer cells in my blood.

    How wonderful!
    Sounds like you've been cured if you ask me. Whatever you are doing now must be keeping the cancer fields clear, too. Good for you!
  • carolenk
    carolenk Member Posts: 907 Member

    How wonderful!
    Sounds like you've been cured if you ask me. Whatever you are doing now must be keeping the cancer fields clear, too. Good for you!

    Excellent
    I think your story is an example of why the tumor assays are not done routinely by all oncologists AND also an example of the power of the "combination therapy"...your combination therapy was above and beyond the chemotherapy.

    I expect you are going to continue to do very, very, well. A good friend said to me recently: "Looks like you are going to have to die of old age like the rest of us."
  • Tethys41
    Tethys41 Member Posts: 1,376 Member
    carolenk said:

    Excellent
    I think your story is an example of why the tumor assays are not done routinely by all oncologists AND also an example of the power of the "combination therapy"...your combination therapy was above and beyond the chemotherapy.

    I expect you are going to continue to do very, very, well. A good friend said to me recently: "Looks like you are going to have to die of old age like the rest of us."

    That's my plan...
    ...To live a long and healthy life. Thanks for the words of support. I know both of you are doing combination therapy as well. I think it is the best option available to us.
  • lindaprocopio
    lindaprocopio Member Posts: 1,980
    Tethys41 said:

    That's my plan...
    ...To live a long and healthy life. Thanks for the words of support. I know both of you are doing combination therapy as well. I think it is the best option available to us.

    My oncologist said "The assays are too far ahead of the drugs."
    My oncologust felt that most of what is learned in the assay cannot yet be applied in the real world. A few years from now there will FDA approved drugs for targeted therapies suggested by the assays. And what happens in a lab isn't necessarily how things will play out inside your body, a very different environment. But I did at least have my fresh tissue assayed for HER2 and ER & PR receptivity, so that I don't waste my time on Herceptin or any hormone inhibitors if they are not apt to work. Everyone should at least do that much.
  • kayandok
    kayandok Member Posts: 1,202 Member
    I had the chemo essaay
    done after my initial deulk in the US. My tumors are grade 3 and were reported to respond well to carbo/taxol. THey did and I did have an 8 month remission. Then, after the next debulk (a couple spots on intestine and in spleen) he again referred to the essay (I did not have a fresh one done). I am glad that I did it, but realize too, that the chemo treamtments would probably have been the same regardless. NOw, I am ready to start topo (irinetocan) and am apprehensive, to be honest, when I look at my chemo essay and see that the topo did not fair well. I have mixed feelings about this whole chemo essay now. In my case, I paid cash for it, and it was expensive.
    my two cents,
    k
  • Tethys41
    Tethys41 Member Posts: 1,376 Member
    kayandok said:

    I had the chemo essaay
    done after my initial deulk in the US. My tumors are grade 3 and were reported to respond well to carbo/taxol. THey did and I did have an 8 month remission. Then, after the next debulk (a couple spots on intestine and in spleen) he again referred to the essay (I did not have a fresh one done). I am glad that I did it, but realize too, that the chemo treamtments would probably have been the same regardless. NOw, I am ready to start topo (irinetocan) and am apprehensive, to be honest, when I look at my chemo essay and see that the topo did not fair well. I have mixed feelings about this whole chemo essay now. In my case, I paid cash for it, and it was expensive.
    my two cents,
    k

    Second and Thrid Round Treatment
    It is my understanding that the assays are more beneficial for second and third, and probably fourth, round treatments, as they show whether the cancer has become immune to previous treatments. It is very possible that if you had an assay done today, k, you would have very differnt results than the one you had done previously. It's possible that the the drug you are about to start will be effective.

    I recently heard that the test that is available in Germany will soon be used here in the U.S. There is a similar test available through a lab in Boston that tests for chemosensitivities. Additionally, it can identify, only a day or two after a chemo treatment, whether the chemo drugs are effective against the tumor. This will be a great tool. Rather than waiting months to determine whether the drug being used is working, the patient and doctor will be able to find out in a couple of weeks.
  • gdpawel
    gdpawel Member Posts: 523 Member
    Proper understanding of tumor assay for chemo sensitivity
    What happen in the Medicare situation was an insurance company called Palmetto GBA was awarded the contract to administer Medicare services for California. Palmetto made an arbitrary decision to discontinue Medicare payment for chemoresponse assays in California, with doing any transparent tech assessment.

    The previous CMS administrator for Medicare in Southern California (NHIC) spent almost the entire 2006 doing a extensive, transparent tech assessment of chemoresponse assays and made the decision that the assays were a perfectly appropriate medical service, worthy of coverage on a “non-investigational” basis.

    It was a local coverage decision (LCD) and not a national coverage decision (NCD) because Medicare has only about 20 doctors and 40 total clinicians working in its coverage office. Also, Medicare doesn't have a single oncologist on staff, yet since the year 2000, they issued 165 restrictions and directives on the use of cancer drugs and diagnostic tools. Private insurers like NHIC, on the other hand, employ thousands of doctors and nurses to do this.

    It should be noted that the Medicare contractor for the state of Pennsylvania continues to provide coverage for chemoresponse assays and that there is an experienced laboratory in Pennsylvania which both provides the assays and accepts Medicare reimbursement as payment in full. California laboratories continue to provide chemoresponse assays with functional profiling (without Medicare reimbursement, possibly requiring patient payment for services).

    In regards to the discussion whether the in vivo response to a drug may be different in the body than in the petri dish. Real life 3D analysis makes functional profiling indicative of what will happen in the body. It tests fresh "live" cells in their three dimensional (3D), floating clusters (in their natural state). Even researchers at Johns Hopkins and Washington University at St. Louis had recently found out, our body is 3D, not 2D in form, undoubtedly, making this novel step better replicate that of the human body.

    Traditionally, in-vitro (in lab) cell-lines have been studied in 2 dimensions (2D) which has inherent limitations in applicability to real life 3D in-vivo (in body) states. Recently, other researchers have pointed to the limitations of 2D cell line study and chemotherapy to more correctly reflect the human body.

    And other recent studies have shown that three-dimensional (3D) tissue culture models have an invaluable role in tumor biology today providing some very important insights into cancer biology. As well as increasing our understanding of homeostasis, cellular differentiation and tissue organization they provide a well defined environment for cancer research in contrast to the complex host environment of an in vivo model.

    Due to their enormous potential 3D tumor cultures are currently being exploited by many branches of biomedical science with therapeutically orientated studies becoming the major focus of research. Recent advances in 3D culture and tissue engineering techniques have enabled the development of more complex heterologous 3D tumor models.

    Blood assays ususally proliferate (grow) cancer cells from a small sample and subject those cells to chemo. Cells 'grown' in the lab will not behave the same way as the actual cancer cells do in your body's own environment. Because they test on subcultured cells (as opposed to fresh tumor cultures) and test the cells in monolayers (as opposed to three dimensional cell clusters), the cell grown in the lab will not behave the same way as the actual cancer cells do in your body's own environment.

    Older technology assay tests failed because scientists looked to see which drugs inhibited the cancer cells' growth (cell-growth endpoint), not which chemotherapies actively killed the tumor cells (cell-death endpoint). Cancer wasn't growing faster than other cells, it's just dying slower. The newer assay testing technology connects drugs to patients by what 'kills' their cells, not by what 'slows' them down.

    All of the work in the past twenty years in the cell culture field has been carried out largely on three dimensional clusters of cells (not monolayers). Work is done exclusively with three dimensional, floating, tumor spheroids. When you test the cells as three dimensional spheroids, they are many-fold resistant in vitro, just as they are in vivo (multicellular resistance).

    The reason why some oncologists are opposed to cell-based assay testing, is they are insesently confused with the old "clonogenic" chemosenstivity assays, the one that Dan Von Hoff had been discredited long ago. When most oncologists refer to "chemosensitivity testing," they are virtually always referring to and thinking about the "human tumor stem cell" assay or "clonogenic" assay. Yet this technology hasn't been used by any private sector laboratory for more than twenty years.
  • Tethys41
    Tethys41 Member Posts: 1,376 Member
    gdpawel said:

    Proper understanding of tumor assay for chemo sensitivity
    What happen in the Medicare situation was an insurance company called Palmetto GBA was awarded the contract to administer Medicare services for California. Palmetto made an arbitrary decision to discontinue Medicare payment for chemoresponse assays in California, with doing any transparent tech assessment.

    The previous CMS administrator for Medicare in Southern California (NHIC) spent almost the entire 2006 doing a extensive, transparent tech assessment of chemoresponse assays and made the decision that the assays were a perfectly appropriate medical service, worthy of coverage on a “non-investigational” basis.

    It was a local coverage decision (LCD) and not a national coverage decision (NCD) because Medicare has only about 20 doctors and 40 total clinicians working in its coverage office. Also, Medicare doesn't have a single oncologist on staff, yet since the year 2000, they issued 165 restrictions and directives on the use of cancer drugs and diagnostic tools. Private insurers like NHIC, on the other hand, employ thousands of doctors and nurses to do this.

    It should be noted that the Medicare contractor for the state of Pennsylvania continues to provide coverage for chemoresponse assays and that there is an experienced laboratory in Pennsylvania which both provides the assays and accepts Medicare reimbursement as payment in full. California laboratories continue to provide chemoresponse assays with functional profiling (without Medicare reimbursement, possibly requiring patient payment for services).

    In regards to the discussion whether the in vivo response to a drug may be different in the body than in the petri dish. Real life 3D analysis makes functional profiling indicative of what will happen in the body. It tests fresh "live" cells in their three dimensional (3D), floating clusters (in their natural state). Even researchers at Johns Hopkins and Washington University at St. Louis had recently found out, our body is 3D, not 2D in form, undoubtedly, making this novel step better replicate that of the human body.

    Traditionally, in-vitro (in lab) cell-lines have been studied in 2 dimensions (2D) which has inherent limitations in applicability to real life 3D in-vivo (in body) states. Recently, other researchers have pointed to the limitations of 2D cell line study and chemotherapy to more correctly reflect the human body.

    And other recent studies have shown that three-dimensional (3D) tissue culture models have an invaluable role in tumor biology today providing some very important insights into cancer biology. As well as increasing our understanding of homeostasis, cellular differentiation and tissue organization they provide a well defined environment for cancer research in contrast to the complex host environment of an in vivo model.

    Due to their enormous potential 3D tumor cultures are currently being exploited by many branches of biomedical science with therapeutically orientated studies becoming the major focus of research. Recent advances in 3D culture and tissue engineering techniques have enabled the development of more complex heterologous 3D tumor models.

    Blood assays ususally proliferate (grow) cancer cells from a small sample and subject those cells to chemo. Cells 'grown' in the lab will not behave the same way as the actual cancer cells do in your body's own environment. Because they test on subcultured cells (as opposed to fresh tumor cultures) and test the cells in monolayers (as opposed to three dimensional cell clusters), the cell grown in the lab will not behave the same way as the actual cancer cells do in your body's own environment.

    Older technology assay tests failed because scientists looked to see which drugs inhibited the cancer cells' growth (cell-growth endpoint), not which chemotherapies actively killed the tumor cells (cell-death endpoint). Cancer wasn't growing faster than other cells, it's just dying slower. The newer assay testing technology connects drugs to patients by what 'kills' their cells, not by what 'slows' them down.

    All of the work in the past twenty years in the cell culture field has been carried out largely on three dimensional clusters of cells (not monolayers). Work is done exclusively with three dimensional, floating, tumor spheroids. When you test the cells as three dimensional spheroids, they are many-fold resistant in vitro, just as they are in vivo (multicellular resistance).

    The reason why some oncologists are opposed to cell-based assay testing, is they are insesently confused with the old "clonogenic" chemosenstivity assays, the one that Dan Von Hoff had been discredited long ago. When most oncologists refer to "chemosensitivity testing," they are virtually always referring to and thinking about the "human tumor stem cell" assay or "clonogenic" assay. Yet this technology hasn't been used by any private sector laboratory for more than twenty years.

    Great Info.
    I always appreciate your comments on this board. Most of the rest of us are relying on personal experience when answering questions. You, however, are posting well researched information. Thanks so much for commenting.
  • gdpawel
    gdpawel Member Posts: 523 Member
    Tethys41 said:

    Great Info.
    I always appreciate your comments on this board. Most of the rest of us are relying on personal experience when answering questions. You, however, are posting well researched information. Thanks so much for commenting.

    When to use assay testing
    Tethys

    I've a lot of personal experience with my wife's situation. That's the reason why I wanted to find out what happened, why, and how not to have it happen again, to others.

    I forgot to answer your inquiry about assay being more beneficial for second and third and fourth round treatments.

    The best outcomes in cancer medicine are known to occur with first line therapies. The selection of the most active, least toxic drug or combination should be the goal of every physician at the time of initial therapy. As cell culture assays have well established performance characteristics (sensitivity and specificity), their positive predictive accuracy (the likelihood that a patient with a sensitive assay will respond to the clinical treatments selected) are highest when they are applied in the first line setting.

    On theoretical grounds, exposure to randomly selected chemotherapeutics, many of which are mutagens, may select for or induce drug resistance, diminishing the likelihood of a good outcome in second line or subsequent therapy.

    The introduction of active targeted agents provides patients the opportunity to receive first line therapies that do not carry the side effects and toxicities of classic cytotoxic chemotherapies. Experience with first line Tarceva (erlotinib) in non-small cell lung cancer provides response rates that exceed those associated with patients selected based on EGFR mutation or overexpression.

    Furthermore, the selection of candidates for combined targeted agents, e.g. EGFR & VEGF inhibitors, etc. provides a growing opportunity to introduce novel combinations into the first line setting. The growing cost and potential toxicity of some of these agents make the application of accurate selective methodologies increasingly crucial.

    First line chemotherapy provides patients their best opportunity for a good outcome. There is no rationale for exposing patients to randomly selected toxic and potentially ineffective therapy when clinically validated selective methodologies can be applied in the first line as well as second line setting and beyond.

    Remember, what is most important, is that you would certainly have a better chance of success if your cancer cells are "chemo-sensitive" rather than "chemo-resistant," where it is more apparent that chemotherapy will improve your survival, and where identifying the most effective chemotherapy would be more likely to improve that survival.

    Best wishes

    Greg
  • LaundryQueen
    LaundryQueen Member Posts: 676
    gdpawel said:

    When to use assay testing
    Tethys

    I've a lot of personal experience with my wife's situation. That's the reason why I wanted to find out what happened, why, and how not to have it happen again, to others.

    I forgot to answer your inquiry about assay being more beneficial for second and third and fourth round treatments.

    The best outcomes in cancer medicine are known to occur with first line therapies. The selection of the most active, least toxic drug or combination should be the goal of every physician at the time of initial therapy. As cell culture assays have well established performance characteristics (sensitivity and specificity), their positive predictive accuracy (the likelihood that a patient with a sensitive assay will respond to the clinical treatments selected) are highest when they are applied in the first line setting.

    On theoretical grounds, exposure to randomly selected chemotherapeutics, many of which are mutagens, may select for or induce drug resistance, diminishing the likelihood of a good outcome in second line or subsequent therapy.

    The introduction of active targeted agents provides patients the opportunity to receive first line therapies that do not carry the side effects and toxicities of classic cytotoxic chemotherapies. Experience with first line Tarceva (erlotinib) in non-small cell lung cancer provides response rates that exceed those associated with patients selected based on EGFR mutation or overexpression.

    Furthermore, the selection of candidates for combined targeted agents, e.g. EGFR & VEGF inhibitors, etc. provides a growing opportunity to introduce novel combinations into the first line setting. The growing cost and potential toxicity of some of these agents make the application of accurate selective methodologies increasingly crucial.

    First line chemotherapy provides patients their best opportunity for a good outcome. There is no rationale for exposing patients to randomly selected toxic and potentially ineffective therapy when clinically validated selective methodologies can be applied in the first line as well as second line setting and beyond.

    Remember, what is most important, is that you would certainly have a better chance of success if your cancer cells are "chemo-sensitive" rather than "chemo-resistant," where it is more apparent that chemotherapy will improve your survival, and where identifying the most effective chemotherapy would be more likely to improve that survival.

    Best wishes

    Greg

    Thanks, Greg
    Glad you are on the team.

    Be well,

    LQ
  • lindaprocopio
    lindaprocopio Member Posts: 1,980

    Thanks, Greg
    Glad you are on the team.

    Be well,

    LQ

    Great slide show on this topic (for the 'eyes wide open' only!)
    For those of you 'eyes wide open' ladies, I found in my files a 102-slide presentation from 2007 on tissue assays. Some of the survival statistics are grim, so you know if you are in an emotional state where you should personally skip this. But also remember that these stats are from 2007, AGES AGO as far as research and survival outcomes, so take the survival stats with a grain of salt. I think this slide show gives you a great idea what live 3-D tissue assays look like and how they can more effectively direct treatments. I know it makes me want to have something sliced out and assayed!! (Can't remember but I think Greg actually is the one who posted this link years back:)

    Here it is: http://weisenthal.org/Weisenthal_ESCIa.pdf
  • This comment has been removed by the Moderator
  • gdpawel
    gdpawel Member Posts: 523 Member
    unknown said:

    This comment has been removed by the Moderator

    Oncotech Closure
    Oceanview

    I take notice you placed Oncotech in your Subject line. Oncotech was an American laboratory providing individual chemoresponse testing as a service to patients and physicians since the mid-1980s. It was co-founded by Drs. Robert Nagourney and Larry Weisenthal. They each left the company in the early 1990s, over disagreements with the controlling investors (4 venture capital companies) over the management and directions of the company. Drs. Nagourney and Weisenthal each started their own small private laboratories to offer related cell culture testing services (they built better mousetraps - cell death assays instead of cell growth assays).

    Oncotech continued operations as a privately-held, venture-capital controlled company until February of 2008, when it was acquired by a Danish biotechnology company called Exiqon, Inc. for $45 million (US) in Exiqon securities. Exiqon replaced the Oncotech CEO and installed its own management team, continuing to operate Oncotech as a wholly-owned subsidiary, with a business model centered around providing chemoresponse assays on a (US) national basis — importantly to Medicare patients.

    Exiqon Oncotech, however, depended on Medicare reimbursement to support its business model. In the USA, Medicare coverage decisions for many types of medical services are made at the regional level (Local Coverage Decision or LCD), by the private insurance companies with which Medicare contracts to administer services to Medicare beneficiaries. Previous Medicare contractors for California made the determination that chemoresponse assays qualified as a Medicare covered service. These included the TransAmerica and National Heritage Insurance (NHIC) companies.

    Most recently, an insurance company called Palmetto GBA was awarded the contract to administer Medicare services for California. Palmetto made the arbitrary decision to discontinue Medicare payment for chemoresponse assays in California. Exiqon Oncotech announced that it was discontinuing operations, because of the withdrawal of Medicare reimbursement for its services. Oncotech was goubled up by Exiqon and eventually spit out by them and hung to dry.

    Business is business, but, at a certain point, business is also about people, and cancer business is, or should be, about cancer patients. Many were saddened by the shuttering of Oncotech’s doors, 25 years after its founding, and are ashamed at the way in which those doors were apparently shutterd.

    It should be noted that the Medicare contractor for the state of Pennsylvania continues to provide coverage for chemoresponse assays and that there is an experienced laboratory in Pennsylvania (Precision Therapeutics) which both provides the assays and accepts Medicare reimbursement as payment in full. California laboratories continuing to provide chemoresponse assays with functional profiling (without Medicare reimbursement, possibly requiring patient payment for services) include Rational Therapeutics, Anticancer, Inc., and Weisenthal Cancer Group.

    Greg
  • gdpawel
    gdpawel Member Posts: 523 Member

    Great slide show on this topic (for the 'eyes wide open' only!)
    For those of you 'eyes wide open' ladies, I found in my files a 102-slide presentation from 2007 on tissue assays. Some of the survival statistics are grim, so you know if you are in an emotional state where you should personally skip this. But also remember that these stats are from 2007, AGES AGO as far as research and survival outcomes, so take the survival stats with a grain of salt. I think this slide show gives you a great idea what live 3-D tissue assays look like and how they can more effectively direct treatments. I know it makes me want to have something sliced out and assayed!! (Can't remember but I think Greg actually is the one who posted this link years back:)

    Here it is: http://weisenthal.org/Weisenthal_ESCIa.pdf

    Permanent Microscope Slides
    Linda

    The slide presentation was done by Dr. Larry Weisenthal at the 41st Annual Meeting of the European Society for Clinical Investigation in Uppsala, Sweden. It is a "eyes wide open" presentation. I have a posting on Cancerfocus.org that would equally be considered the same about The Bayesian Method. The Bayesian methodology makes the assays more accurate in the prediction. Anyone with an interest in statistics may enjoy reading it.

    Part of the functional profiling assay entails the DISC assay which the entire contents of the cell culture are cytocentrifuged onto permanent microscope slides for direct "visualization" of tumor cells and for a permanent archival record. The DISC assay was the first of the new-generation functional profiling methods to feature the "cell-death" endpoint (point of termination) upon which nearly all new-generation funcitonal profiling assays are based.

    And "real life" 3D analysis increases accuracy to make functional profiling indicative of what will happen in the body, and is the reason why the lab requires at least a "tru-cut" (larger bore) biopsied tumor specimen. In Johns Hopkins study of 3D analysis, finding out how cells move and stick to surfaces was critical to their understanding of cancer and other diseases. Their study demonstrated for the first time that the way cells move inside a three-dimensional environment is fundamentally different from the behavior they've seen in conventional two-dimensional (2D) flat lab dishes. Both qualitatively and quantitatively different.

    Greg
  • gdpawel said:

    Oncotech Closure
    Oceanview

    I take notice you placed Oncotech in your Subject line. Oncotech was an American laboratory providing individual chemoresponse testing as a service to patients and physicians since the mid-1980s. It was co-founded by Drs. Robert Nagourney and Larry Weisenthal. They each left the company in the early 1990s, over disagreements with the controlling investors (4 venture capital companies) over the management and directions of the company. Drs. Nagourney and Weisenthal each started their own small private laboratories to offer related cell culture testing services (they built better mousetraps - cell death assays instead of cell growth assays).

    Oncotech continued operations as a privately-held, venture-capital controlled company until February of 2008, when it was acquired by a Danish biotechnology company called Exiqon, Inc. for $45 million (US) in Exiqon securities. Exiqon replaced the Oncotech CEO and installed its own management team, continuing to operate Oncotech as a wholly-owned subsidiary, with a business model centered around providing chemoresponse assays on a (US) national basis — importantly to Medicare patients.

    Exiqon Oncotech, however, depended on Medicare reimbursement to support its business model. In the USA, Medicare coverage decisions for many types of medical services are made at the regional level (Local Coverage Decision or LCD), by the private insurance companies with which Medicare contracts to administer services to Medicare beneficiaries. Previous Medicare contractors for California made the determination that chemoresponse assays qualified as a Medicare covered service. These included the TransAmerica and National Heritage Insurance (NHIC) companies.

    Most recently, an insurance company called Palmetto GBA was awarded the contract to administer Medicare services for California. Palmetto made the arbitrary decision to discontinue Medicare payment for chemoresponse assays in California. Exiqon Oncotech announced that it was discontinuing operations, because of the withdrawal of Medicare reimbursement for its services. Oncotech was goubled up by Exiqon and eventually spit out by them and hung to dry.

    Business is business, but, at a certain point, business is also about people, and cancer business is, or should be, about cancer patients. Many were saddened by the shuttering of Oncotech’s doors, 25 years after its founding, and are ashamed at the way in which those doors were apparently shutterd.

    It should be noted that the Medicare contractor for the state of Pennsylvania continues to provide coverage for chemoresponse assays and that there is an experienced laboratory in Pennsylvania (Precision Therapeutics) which both provides the assays and accepts Medicare reimbursement as payment in full. California laboratories continuing to provide chemoresponse assays with functional profiling (without Medicare reimbursement, possibly requiring patient payment for services) include Rational Therapeutics, Anticancer, Inc., and Weisenthal Cancer Group.

    Greg

    This comment has been removed by the Moderator
  • gdpawel
    gdpawel Member Posts: 523 Member
    unknown said:

    This comment has been removed by the Moderator

    DNA/RNA-type testing
    ssbeari

    The predictions are based on the fact that a higher percentage of people with similar genetic profiles or specific mutations may tend to respond better to certain drugs. All DNA/RNA-type tests are based on "population" research (not individuals). This is a refinement of statistical data, like conventional treatment is based on previous randomized clinical trials (population studies). If you are okay with that, it might be worthwhile.

    If not, the functional profiling approach involves real-time assessment of the "individual" (not populations) of "living" cancer and endothelial cell behaviors actually in the presence or absence of anti-cancer or anti-angiogenic drugs. This method accounts not for only the existence of gene and proteins but also for their functionality and for their interaction with other proteins, and other processes occuring within the cell.

    Greg