Here are answers to some of the questions we hear most often. If there is something you were wondering about that doesn’t appear here, please give a us call and we will be glad to answer it for you.
What is personalized cytometric cancer profiling?
Thousands of individual processes and chemical interactions occurring within a cancer cell determine whether the cell will or will not respond to treatment with a chemotherapy drug. Personalized cytometric profiling assesses the combined effect of all of these processes as they occur in real time within your living cancer cells.
How is personalized cytometric cancer profiling performed?
A biopsy sample containing living cancer cells is removed from your body thorough surgery or other biopsy procedure. In our laboratory, the cancer cells are extracted from the sample, taking great care not to harm them. Your living cancer cells are distributed among several 96-well polystyrene microtiter plates. Each well will contain about 10,000 of your cancer cells. A very broad range of anti-cancer drugs is selected by Dr. Weisenthal for testing against your cancer cells. A different anti-cancer drug or drug combination is added to each well. Your cells are held in carefully-controlled temperature and CO2 incubator conditions during a 96 hour exposure period. The cells are not "grown" or multiplied as in older methods as this could produce inaccurate test results. The testing process is not intended to precisely replicate what occurs in the human body - that would be impossible. Instead, the drug exposure conditions and drug concentrations were meticulously calibrated over many years of assay development to achieve the highest possible rate of correlation between what happens in the laboratory and what happens in the patient.
Once the drug exposure period is reached the cell killing effect of each drug upon the cancer cells is measured. This is done using at least three and as many as five different laboratory technologies. Multiple tests are used for increased accuracy and to obtain the maximum amount of information about your cancer cells Each technology evaluates tumor cell killing in a manner complementary to that of the other technologies that Dr. Weisenthal selects for you. The choice of technologies used for your comprehensive analysis is based upon your cancer type, the specific drugs being tested for you, and factors specific to your individual biopsy specimen.
Each, separate drug activity measurement is then analyzed by Dr. Weisenthal, who examines and interprets dozens of microscope slides upon which your cells, stained and then counterstained, are mounted. Dr. Weisenthal integrates data from each of the different tests carried-out for you and performs computer comparisons of your various test results with an extensive, multi-parametric index database. This is a critical step that converts otherwise crude cell killing data into information that is meaningful, highly specific to you, and clinically-useful for you and your physician. Dr. Weisenthal compiled his cytometric profiling database laboriously over a twenty year period. It is far more detailed than databases used by any other cytometric profiling laboratory in the world. The aim is to achieve the highest levels of accuracy and clinical relevance. For more information on the importance of Dr. Weisenthal’s index database, please click here.
Who is in charge of evaluating and reporting the results of my profiling studies?
Results of all of the tests are personally and individually evaluated by Larry Weisenthal, M.D., Ph.D.. Dr. Weisenthal is a physician - a board certified Medical Oncologist (cancer physician) who was a clinical associate and research fellow at the National Cancer Institute. Currently, he is Clinical Professor of Medicine (Hematology/Oncology) at University of California Irvine School of Medicine. He is widely acknowledged to be the world’s foremost expert in personalized cytometric cancer profiling. In addition to his medical degree, Dr. Weisenthal holds a Ph.D. in pharmacology. Dr. Weisenthal examines your tumor cells microscopically before and after testing and assesses data produced by the three complementary laboratory technologies used on your behalf. Then, within the context of your clinical situation and treatment history, he interprets data produced by your profiling analysis. This involves performing mathematical comparison of your test results with an extensive index database. Based upon his knowledge of the drugs and of your cancer type and clinical situation, along with your individual test results, Dr. Weisenthal determines which drug or combinations of drugs have the best chance of providing benefit to you. For each test, Dr. Weisenthal devotes more than 8 hours of hands-on, individualized effort. This is in addition to several hours spent by experienced laboratory technologists in preparing your specimen for testing. This is done meticulously, under Dr. Weisenthal’s direct supervision, to create the best possible testing environment and produce the most accurate and most useful test results.
What will personalized cytometric cancer profiling tell me?
The tests will show if your cancer cells were killed by exposure to one or more of the 20 to 30 different anti-cancer drugs or drug combinations that might otherwise have been considered as possible treatments for your type of cancer. Based upon multiple factors identified in the process of testing your cancer cells, Dr. Weisenthal will apply a mathematical algorithm that will classify each drug tested for you on the basis of its probable clinical benefit or lack of benefit. The most promising treatment for you can be identified and ineffective treatments can be avoided.
Will personalized cytometric cancer profiling cure my cancer?
Personalized cytometric profiling is a comprehensive laboratory analysis that can evaluate but cannot change the chemical make-up of your cancer cells. If a drug or combination of drugs exists that is effective against your cancer cells, cytometric profiling can pinpoint that drug or those drugs for you. However, if no drug exists that is able to control your cancer, personalized cytometric profiling cannot alter that fact. Numerous studies have shown that cytometric profiling can show which drugs have higher or much higher than average likelihoods of success, which drugs have lesser likelihoods of success, and which drugs have virtually no likelihood of success. This knowledge is an invaluable aid in treatment selection. But the tests by themselves cannot change the fundamental nature of your illness. The goal of personalized cytometric profiling is to afford you the best possible chance for treatment success by pinpointing specific drugs that are found in the laboratory to be the most effective at killing your own tumor cells. At the same time, personalized cytometric profiling avoids wasting valuable time on hopeless treatments and spares you needless suffering from side-effects of costly drugs that cannot possibly help you.
Are drugs tested as single agents or in drug combinations?
Successful cancer treatment most frequently involves the use of drug combinations. Dr. Weisenthal always tests each drug for you individually for increased accuracy and to pinpoint the most active drugs for potential use in drug combinations. In addition, certain drugs will be tested in combination if there exists a scientific basis to support the possibility of true drug synergy.
Who can have personalized cytometric cancer profiling?
A patient must have living cancer cells in his or her body. The cells must be accessible by means of surgery or other biopsy procedure. The tests cannot be performed on dead cells or on tissues that were obtained in a past surgery or biopsy procedure.
What are some likely sources of cancer cells in my body for testing?
A solid tumor mass is the most commonly tested specimen type but malignant effusions often are usable when these are available. For many leukemias and for some multiple myelomas and lymphomas, blood or bone marrow might contain cancer cells in numbers sufficient for testing. For details about specimen requirements and special handling techniques please click here to jump directly to that section.
How many drugs will be tested for me?
The number of drugs we can test is determined by the number of drugs potentially relevant to your cancer type and also by the number of living tumor cells contained in the biopsy specimen we receive. A relatively large biopsy specimen might contain only a small number of living tumor cells whereas a smaller specimen could yield an abundance of suitable cells. We do not “grow” cells in culture as some labs do in order to expand the sample size. This might be a convenience for the testing lab but it can also change the behavior and genetic make-up of the cells and artificially skew your test results. For maximum accuracy we test your cancer cells just as they were removed from your body.
Testing begins immediately on the day your sample arrives. Therefore, the cells we receive from your physician are all that we will have for testing. We request a gram or more of tissue. For reference, that is a piece of tissue somewhere between the size of a lima bean and a radish. Your physician can help by selecting one to two grams of firm, living tumor tissue, by not damaging the cells with electrocautery knives, toxic inks, formalin, or other harmful items, by placing the specimen quickly in fresh transport media, by keeping the specimen cold but not frozen, and by shipping your specimen on the same day it is collected. For more on specimen requirements, please click here. To learn more about how your drugs are selected for you for testing, please click here.
How do I know if I can have personalized cytometric cancer profiling?
Your doctor will know if you have accessible tumor cells. However, you must also be well enough to receive chemotherapy. Please feel free to phone us with your questions. We probably can tell from hearing about your specific illness and clinical situation if you are a good candidate for personalized cytometric profiling.
How can I arrange for personalized cytometric cancer profiling?
Phone us at (714) 596-2100 - or else ask your doctor to do so. Government regulations require that a physician must order testing on your behalf but we certainly do invite you to phone or email us to help in making the arrangements if you would like to do so. It should be noted that regulations also require that laboratory test results must be reported to the physician who ordered the testing and to other physicians who are designated on the assay order form. Your physician should be happy to furnish you with a copy of your test results but, by law, we cannot report test results directly to patients.
The most important thing is for someone - whether it is you or your physician - to contact us in advance so that we can make sure that specimen transport materials reach your physician or the hospital before your surgery or biopsy procedure. Included in our transport package are specimen handling instructions, overnight shipping labels, specimen containers, and a special transport medium that will keep your cancer cells alive during conveyance to our laboratory. Please be sure to call us a minimum of two days prior to your scheduled surgery date to make sure that the critical specimen transport materials reach your physician on time.
How much does profiling cost?
The cost of testing can vary widely, depending upon the number of drugs and drug combinations tested for you. Fees for personalized cytometric profiling can range from $2,200 to as much $9,000. The number of drugs to be tested is determined by what is appropriate for you in your specific clinical situation, by what additional drugs and combinations your doctor requests, and by the quantity and quality of the biopsy specimen that is furnished to our laboratory.
Will healthcare insurance cover the costs of my profiling tests?
Personalized cytometric profiling will not be covered under your Medicare policy. If you are a Medicare patient and if you do not have supplemental insurance your testing service fees will not be reimbursed. If you have private insurance, coverage for the tests depends upon the policies of your individual carrier and upon the provisions of your specific insurance plan. It is possible that your insurance will cover some portion of your testing costs although normal co-payment and deductible amounts will apply. However, some insurance carriers pay for only a relatively small percentage of the costs while many carriers will deny insurance claims entirely. Payment is required at the time of service. Our billing coordinator can assist you in filing for reimbursement with your insurance carrier.
Is Personalized Cytometric Cancer Profiling available to persons living outside of the U.S.?
Yes. We routinely perform testing for patients from around the world. Specimen requirements are the same as for patients living in the U.S.. Biopsy specimens should arrive at our laboratory no more than 48 hours after removal from the patient. We work closely with FedEx to ensure that specimens from overseas arrive on time and we have had great success in making this happen. It is extremely important that you contact us at least 48 hours before surgery so that we can make arrangements and also provide international declarations, shipping labels, specimen transport media, and other necessary materials. Please phone us at 001-714-596-2100.
WE’RE GLAD TO HELP
If you have questions that aren’t covered here - or if you would like to discuss those that are - please don’t hesitate to phone us. Chances are, you’ll speak directly with Connie Rueff, M.T., who is our laboratory manager. Connie has been at this for about 20 years now and she definitely knows what she is talking about. Connie is friendly, patient, and always happy to speak with patients and physicians.
Give Connie a call at 714-596-2100 during normal business hours. That would be from 9 AM until 5 PM, Monday through Friday. Please remember that we are located in California and so we operate on Pacific time.
QUESTIONS AND ANSWERS