Here is a brief summary of basic facts. It quickly covers the questions most commonly asked. For further information and also for a slightly different - and in some cases more technical - view you might wish to view the Healthcare Professionals section.
What is Functional Tumor Cell
Profiling?
Thousands of individual processes and
chemical interactions occurring within a cancer cell determine whether or
not the cell will or will not respond to treatment with a chemotherapy drug.
Functional Tumor Cell Profiling assesses the combined effect of all
of these processes as they occur in real time within the living cancer cell. (To
learn more about "Functional" profiling versus "Static" profiling and "Whole
Cell" profiling versus "Partial Cell" profiling,
please click here.)
How is Functional
Tumor Cell Profiling performed?
Living cancer cells are removed from your body and are exposed in the laboratory over a carefully controlled 96 hour incubation period to many different anti-cancer drugs. The cells are not "grown," as in older methods. (Click here to read more about the incubation process.) For each patient, the effect of each drug upon the cancer cells is measured using three different laboratory technologies for increased accuracy and to obtain the maximum amount of information about your cancer cells (Why three? Click here.) Each technology evaluates tumor cell killing in a manner which is complementary to that of the other technologies which we select for you. (Cell Death versus cell proliferation? Click here for an explanation.) The choice of technologies used for your comprehensive analysis is based upon your cancer type, the specific drugs being tested, and factors specific to your individual specimen. Each activity measurement is analyzed by comparison with an extensive index database. Weisenthal Cancer Group has developed an index database which is far more detailed than those used by other laboratories in order to accord the maximum relevance and reliability to your Profile results. For more information on the importance of the Weisenthal Cancer Group index database, please click here.
Who is responsible for 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., an NCI-trained, board certified Medical Oncologist (cancer
physician) who also holds a Ph.D. in pharmacology. Pharmacology is the
study of the chemical properties, mechanisms of activity, and the effects
and side-effects of drugs. Dr. Weisenthal microscopically examines
your tumor cells before and after testing, along with data produced by the
three different technologies used on your behalf. Then, within the
context of your clinical situation and treatment history, he interprets data
produced by your profiling analysis by mathematical comparison 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.
What will Functional Tumor Cell
Profiling tell me?
The tests show if your cancer cells were
killed by exposure to one or more of the 20 or so different anti-cancer
drugs that might otherwise have been considered as possible treatments for
your type of cancer.
Will Functional Tumor Cell Profiling cure my cancer?
Functional Tumor Cell 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, Functional Tumor Cell Profiling
can pinpoint that drug or those
drugs for you. However, if no drug exists that is able to control your
cancer, Functional Tumor Cell Profiling cannot alter that fact. Numerous studies have shown that Functional Tumor
Cell Profiling can show us which drugs have a higher or much higher than average
likelihood of success, which drugs have a lesser chance of success, and
which drugs have virtually no chance of success. This can be an invaluable aid in treatment
selection. But the tests by themselves cannot change the fundamental
nature of your illness. The goal of
Functional Tumor Cell Profiling is to afford you the best possible chance
for treatment success by pinpointing those specific drugs that are the
most highly active in combating your own tumor cells. At the same time,
Functional Tumor Cell Profiling saves valuable time and spares needless exposure to toxic and
costly drugs which might otherwise have been chosen for you but which cannot possibly help you.
Are drugs
tested as single agents or in combination?
We always test each drug individually but
some of the drugs are also tested in combination with an additional,
carefully selected drug if there
is a rational basis to support possible drug synergy.
Who can have the
Functional Tumor Cell 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 profiling?
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.
The number of drugs we can test is determined
by the number of tumor cells we can isolate from the tissue we receive.
Sometimes a very large piece of
tissue contains mostly normal cells and only a small nest of viable tumor
cells. On the other hand, a
smaller specimen might yield an abundance of useable cells.
We don't grow cells or try to multiply them - we test the cells
fresh, on the day we receive them and so the sample we receive is all that we will
have to work with. 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, viable 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 that it is collected.
For more
on specimen requirements,
please click on the link. To
learn more about how your drugs are selected for you for testing, please
click here.
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.
How do I arrange for Functional Tumor
Cell 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, legally, 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 serum that will keep your cancer cells
alive while enroute 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.
It depends upon the number of drugs tested
for you.
Fees for Functional Tumor Cell Profiling
analysis can range from $2000 to $6,000, depending upon the number or drugs
and combinations tested.
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?
Functional tumor cell 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 very possible
that your insurance will cover most or all of your testing costs, although
normal co-payment and deductible amounts will apply.
However, many insurance carriers pay for only a portion of the costs
and some carriers will deny your insurance claim entirely. If this
should occur, our reimbursement specialist will gladly assist you in appealing
an unfavorable
determination.
In the past, many such appeals have been successful.
However, you will be responsible for balances not paid by your
carrier.
As a courtesy, we are pleased to bill your insurance carrier directly
on your behalf.
Is Functional Tumor Cell Profiling available to persons living outside of
the U.S.?
Yes. We routinely perform testing for patients from all over 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 provide shipping labels, specimen transport medium, and other necessary materials. Please phone us at 001-714-596-2100
.
Quick Facts
VERY IMPORTANT
Please phone us at least two days before your surgery or biopsy - sooner if possible. Living cancer cells are required. Testing cannot be arranged after surgery is performed. Click on this link for specimen handling instructions,
·
It is
important that you phone us prior to your surgery or biopsy procedure so
that we can rush specimen transport
medium and shipping materials to your doctor or hospital.
Without prior arrangement, it is extremely unlikely that biopsy
materials suitable for Functional Tumor Cell Profiling will be available.
·
Your biopsy
specimen must NOT be placed in formalin or other fixative.
Living cancer cells are required for Functional Cell Profiling.
Formalin exposure kills cancer cells instantly, making testing
impossible.
·
.
