Issues Concerning the Success of JNJ's Novel Test:
- Cost will be the primary concern for any novel treatment or diagnostics. This includes costs incurred by the hospital, doctor's office, and insurance companies and if they cover the costs of the test. Costs include a new instrument, supplies to perform the test, training that may be needed in performing and interpreting the tests, and many other things. The current CellSearch test cost a couple hundred thousand dollars. Patients may draw the shortest straw.
- The technology is still in early stage of development. If successful, the instrument can be expected to hit the market in a few years.
- What real clinical value lays in detecting a single cell?
- It is well known that a tumor consists of a heterogeneous cell population. Each cancer cell is different due to the high mutation rate. A single cell would not represent the tumor and metastases.
- If the patient has a solid tumor, detection of a cancer cell in the blood would mean the cancer has metastasized. Metasized tumors are extremely difficult to treat and patients often relapse. However, this is great news if detected early and no new distant tumors have formed.
- Tumors metastasize after growing to a certain size and being depleted of nutrients. This test will not give the earliest indication of cancer.
- The test requires a couple of teaspoons of blood, roughly 10 milliliters (mL). An average adult has roughly 5 liters of blood. This means that for every 1 cancer cell detected by the test, there are 499 more cancer cells circulating in the blood.
- Not all cancers metastasize via the blood. Some cancers metastasize via the lymph system such as breast cancer. The test may be of much use for these cancers.
- The test may be better for blood cancers such as leukemia and lymphoma. It just makes more sense to tailor therapy based on blood samples when the cancer is of the blood.
- It is indirect to base therapeutic decisions on presence of cancer cells in the blood. There are many reasons why cancer cells will not be present in the blood. The tumor may be in temporary remission. Also, if the chemotherapy is very effective, it may cause tumor lysis syndrome and a lot of cellular debris may be detected in the blood resulting in a false positive.
- This is a good shot at personalization of medicine, but does not hit the bull's eye. Each patient is going to have different tumor markers and respond to therapy in different ways. The patient's cancer is going to mutate in unique ways. The test needs to account for this fact. It is more of an art than science. The report in PNAS states that the antibody on the microchip was specific for epithelial cell adhesion molecule (EpCAM). I expect the final version to contain several specific antibodies for different molecular markers.
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