FDA: New Breast Cancer Prognostic Test

The U.S. Food and Drug Administration (FDA) has cleared a new breast cancer specific molecular prognostic test, reports a statement by the FDA.

According to the press release, the newly approved test determines the likelihood of breast cancer returning within five to ten years after a woman's initial cancer. It is the first cleared molecular test that profiles genetic activity.

The MammaPrint® test uses the latest in molecular technology to predict whether existing cancer will metastasize (spread to other parts of a patient's body), explains the FDA statement. The test relies on microarray analysis, a powerful tool for simultaneously studying the patterns of behavior of large numbers of genes in biological specimens.

The FDA asserted that as the recurrence of cancer is partly dependent on the activation and suppression of certain genes located in the tumor, prognostic tests like the MammaPrint® can measure the activity of these genes, and thus help physicians understand their patients' odds of the cancer spreading.

MammaPrint® was developed by Agendia, a laboratory located in Amsterdam, Netherlands, where the product has been on the market since 2005.

Agendia compared the genetic profiles of a large number of women suffering from breast cancer and identified a set of 70 genes whose activity confers information about the likelihood of tumor recurrence. The MammaPrint® test measures the level of activity of each of these genes in a sample of a woman's surgically removed breast cancer tumor, then uses a specific formula, known as an algorithm, to produce a score that determines whether the patient is deemed low risk or high risk for spread of the cancer to another site. The result may help a doctor in planning appropriate follow-up for a patient when used with other clinical information and laboratory tests.

According to the FDA statement, the MammaPrint® is the first cleared in vitro diagnostic multivariate index assay (IVDMIA) device.

Comments

[Jamie Hegarty]

This is great news for breast cancer patients. The MammaPrint®, developed by Agendia, seems to provide very reliable prognostic data. When researchers were developing the test, they evaluated its accuracy by comparing its results to microassay analysis results of known samples. The current microassay analysis uses the same 70 genes, but it was not designed to process large amounts of data at one time, which makes it too costly and time consuming to be practical. The researchers found that this new test had a high correlation for prognostic prediction when compared to the current one, with a p value < 0.00001, and it was more accurate when results were close to the threshold between a poor prognosis and a good prognosis.

[J.Kathryn Bryan]

Researchers, healthcare providers and patients alike are usually thrilled at the advent of a new diagnostic tool, especially for a disease as devastating and widespread as breast cancer. Surely, doctors are glad that researchers have developed a means by which to fine-tune long-term breast cancer prognosis when cancer survivors, their families and loved ones are on the roller coaster that is life after cancer.

But what happens after the MammaPrint® is run, the prognosis is made and the breast cancer patient leaves her physician’s office? A more optimistic prognosis might lull one patient, still in recovery from her first bout of treatment, to allow allowing her cancer vigilance to slip by the wayside. Alternatively, a patient who receives a less optimistic prognosis from the MammaPrint® might experience overwhelming fear that further degrades her quality of life. Regardless of the results of a MammaPrint® in any one instance, I hope that doctors in the United States who use this tool take the time to explain the importance of not allowing a prognosis to overrule one’s life.

[Dexter Otis Grenne]

Keeping one step ahead of the cancer is an important part of beating it. Even if the patient knows that in five years he/she will have a recurrence, at least there is preparation time. The doctors will keep an eye on it, and once it reappears it can be taken care of. However, this brings to mind a thought about the usefulness of Mammaprint. Wouldn't the patient want to keep a constant eye on it anyway, even without knowing one way or another if the cancer will reappear?

[Anonymous]

I cannot emphasize enough the importance of routine examinations and check-ups. That way, we can save more lives.

[Julie]

I cannot stress enough the importance of follow-up care. With the help of the MammaPrint we can get an idea of what cancer recurrence could be in the future. I also hesitate to use this tool widely for reasons mentioned above. It could greatly impact quality of life in a patient, depending on the test results. I've known people that never believed they were sick, and fought as hard as they could for a recovery and lasted a lot longer than anyone ever would have expected. The will for life is so greatly important, and a poor prognosis from a lab test could damage that will.

On the other hand, if a patient knows the cancer has a high likelihood of returning, one could also fight harder to nip it in the bud and be aware of the possibility of recurrence.

Today's ever advancing technology is wonderful, but let us not forget the more important human factor. :)

[Rachelle Provost]

It's scary how common breast cancer has become. I can't help but wonder what is responsible for the increased rates of cancer. I know that part of it is just an increased diagnosis and that the illness has always existed, and we are much more aware of its presence now. But without any data on the long-term effects of all of the radiation waves flowing through the air, it's scary to think of what we may be doing to our health. Between cell phones, wireless Internet, wireless this, wireless that, it can't be good for you! I think it's one of the ironies of "advanced and developed civilizations." We may have better technology that makes our lives "easier," but we are also hurting ourselves by allowing ourselves to become lazier (hence the obesity epidemic) and surrounding ourselves with unnatural radio waves (a potential cancer-causer).

[Emily P.]

I was thinking the exact same thing as J. Kathryn Bryan. I think if I had just gone through the trauma of getting through one bout of breast cancer, I’d almost rather not know if it was likely to metastasize. Of course, one should continue regular check-ups, but I’d rather live with the optimism of assuming my cancer cured.

[MV]

The MammaPrint is beneficial in the sense that it gives the patient a better idea of his/her future. As mentioned previously, this is only a tool and not the end-all conclusion. It is still important to follow up with your doctor, but it can provide a sense of comfort or assurance when going through something as difficult as cancer.

[Paul]

It seems to me that the utility of this device could be profound, but how it's used will make or break it. The results, good or bad, can be problematic if not delivered the right way. Good news, without the explanation of the limitations of the test or importance of staying vigilant could cause more harm than good. Alternately, bad news, without support could lead a patient on a path of even more suffering and pain. But, if used right, this could help people do long-term planning and find acceptance with such a crushing disease. Personally, I'd want to know.

[inflammatory breast cancer symptoms]

Symptoms from inflammatory breast cancer come develop suddenly and can be similar to an infection of the breast (mastitis), which can be effectively treated with antibiotics. Symptoms that do not go away despite antibiotic treatment should be discussed with a doctor. Further testing to rule out inflammatory breast cancer may be needed.

[sphin]

The symptoms of breast cancer should be check daily. We really have to do this for our own safeness.