Frequently Asked Questions

Without cytometric profiling, how are cancer drugs selected?

Most cancer physicians today still select chemotherapy drugs because they worked for some percentage of patients enrolled in a clinical trial that was conducted in the past.  There are problems with this method of therapy selection.  In a clinical trial, new drugs and drug combinations (these are often called “study drugs”) are administered to patients at random.  Treatment outcomes are then observed. Some patients in a clinical trial might benefit from the study drug but, in every trial, many patients do not benefit. However, in different clinical trials, different study drugs also provide benefit to some percentage of patients - but not others.  Now you know why so many different drugs are approved for use in the same cancer type. This also demonstrates why it is so important to learn in advance which drugs are most likely to benefit which patients.  

And what about new drugs and new drug combinations still undergoing clinical trials analysis? Typically, it takes several years before clinical trials results are published.  Meanwhile, patients are denied access to potentially effective treatments which might have been identified for them years earlier through the use of personal cytometric profiling.  For more information on tis topic, please click here.

Is there
scientific proof
that cytometric profiling works?

An extensive body of evidence supports the accuracy and clinical utility of cytometric profiling. The evidence derives from decades of uniformly positive, published studies collectively involving more than 3,000 patients. These studies were conducted by independent investigators worldwide. Study designs have varied. They have included prospective and retrospective studies, blinded and non-blinded studies, and randomized and non-randomized studies. However, despite a wide diversity in investigators and in study designs, personalized cytometric profiling has always correlated positively with response, with progression-free survival, and with overall survival. Personalized cytometric profiling has also accurately recapitulated the established activity of individual chemotherapy agents while consistently mirroring the expected clinical behaviors of different cancer types and the known molecular biology of cancer.

Will Personalized Cytometric Profiling cure my cancer

Personalized cytometric profiling is a comprehensive laboratory analysis that accurately evaluates chemotherapy drugs for activity against your own cancer cells.  If a drug or combination of drugs exists that effectively kills your cancer cells, cytometric profiling will identify that drug or those drugs for you.  However, cytometric profiling by itself cannot change the chemical make-up of your cancer cells or transform the fundamental nature of your illness.  If no drug exists that is able to cure or control your cancer, personalized cytometricprofiling cannot alter that fact. Goals of cytometric profiling are twofold:

1. To afford you the the best chance for treatment success by focusing on those drugs with proven ability to kill your cancer cells.

2. To save you from needless, time-wasting treatments with drugs that cannot possibly help you.

Are drugs tested as single agents or as drugs combinations?

All drugs are tested for you individually but certain drugs are also tested in combination with other drugs if there exists a rational basis to support the possibility of beneficial drug synergy. Drug synergy occurs when the combined effect of a drug combination exceeds the simple additive effect of the individual drugs in the combination. 

Who can have Personalized Cytometric Profiling?

First, you must be a candidate for chemotherapy.  That means that you must be willing to undergo chemotherapy and you must be strong enough to receive it. Most patients qualify in this this regard. In addition, you must have living cancer cells in your body and those cancer cells must be accessible through surgery or some other biopsy procedure. Bear in mind that living cancer cells are required for the tests.  For this reason, your cytometric profiling tests cannot be performed on archival tissues, such as microscope slides or paraffin blocks, that were obtained through a past surgery or biopsy procedure.

What are some potential sources of living cancer cells in my body?

Several possibilities exist. A solid tumor mass that is accessible to biopsy is ideal.  For some patients, malignant effusions (such as fluids that accumulate in the chest or abdominal cavity) might also yield cells that are suitable for testing. For many leukemias and for some multiple myelomas and lymphomas, blood or bone marrow might also contain sufficient cancer cells.  Dr. Grace collaborates with surgeons and interventional radiologists who are skilled at obtaining samples for use in the cytometric profiling tests that Dr. Grace will order on your behalf.

Are there other tests that can help to personalize chemotherapy?

Scientists have been using a technology called RT-PCR along with other DNA-based methods to assess patterns of gene expression within the cancer cell. The method is called molecular testing. The goal is to identify genetic mutations that predict for the activity of certain chemotherapy drugs.

However, even if the mutation is present, it means only that there is a theoretical possibility that a drug will work.  In molecular testing, the patient’s cancer cells are never exposed to any of the candidate drugs and so functional cell behaviors, involving interaction among multiple intracellular processes and also important cell to cell signaling are not accounted for.  Molecular testing cannot test for activity of drug combinations or for activity of an entire class of drugs that work by interfering with tumor vasculature. Molecular testing also cannot discriminate between activity of different drugs in the same class. We use molecular tests at when it is appropriate, often as an adjunct to cytometric profiling, but we do so with full awareness of the capabilities and limitations of these tests.

What do personal cytometric profiling tests cost?

Dr. Grace has no connection with Weisenthal Cancer Group, the independent reference laboratory that actually performs your tests. Weisenthal Cancer Group is our primary supplier lab for cytometric profiling (selected because we believe that Dr, Weisenthal is the best in his field) and we are their client - just as you, as the patient, are their clientTherefore, we have no control over pricing or billing for your tests.  Weisenthal Cancer Group informs us that their testing fees are variable, depending upon the number of drugs they test for you. The number of drugs to be tested is determined by what is appropriate for you in your specific clinical situation.  In the past, we have seen fees for personalized cytometric profiling which range from $2,000 to over $6,000.

For any questions you may have relating to pricing or billing for your tests, we refer you directly to Weisenthal Cancer Group at (714) 596-2100.

Does insurance cover the costs of cytometric profiling?

Dr. Grace’s professional fees will likely be covered by your private insurance carrier or by Medicare, consistent with the terms of your individual insurance policy. Our office staff will be able to tell you in advance what to expect in the way of insurance coverage for care provided to you by Grace Oncology.  

Fees for laboratory tests involved in your personalized cytometric profiling will be billed to you directly by Weisenthal Cancer Group, an independent medical laboratory. We advise that you contact their billing department directly in advance of your testing. We asked Weisenthal Cancer Group for a statement, based upon their experience. They provided us with the following, excerpted from their website:

“Medicare does not cover costs for personalized cytometric testing. If you are a Medicare patient your testing service fees will not be reimbursed. If you have private insurance, coverage for the tests depends upon the established coverage practices of your individual insurance 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. Private insurance carriers who do pay for the tests often allow only a small percentage of the actual fees.  A large number of insurance carriers routinely deny personalized cytometric profiling claims altogether. As a courtesy, we are pleased to bill your insurance carrier directly on your behalf. In the event of denial, we will provide materials that might assist you in filing an appeal.”