FDA Approves New Tests Impacting Mesothelioma Diagnosis

Getting a mesothelioma diagnosis is not easy. Mesothelioma is a rare cancer of the lining around the internal organs (most commonly the lungs) that is caused by asbestos exposure. Mesothelioma symptoms can look like several other diseases, including more common forms of lung cancer. Even if you know you are at risk, it can take several steps and some time to confirm a mesothelioma diagnosis.

Once you have your mesothelioma diagnosis, that’s still not the whole picture. New Immunotherapy treatments go after cancer cells based on the ways that those cells operate in your body. To understand whether or not an immunotherapy treatment such as Keytruda would work for you, your doctor might need additional tests.

A new diagnostic test, just approved by the FDA, could make a detailed mesothelioma diagnosis much easier to accomplish. If a proposal for Medicare to pay for this test is approved, sophisticated gene sequencing of cancerous tumors could become widely available. These combined developments are a huge breakthrough for mesothelioma patients.

Beyond a Mesothelioma Diagnosis

If you have been diagnosed with mesothelioma, you know it isn’t usually the first thing your doctor thought about when you reported a persistent fever, shortness of breath, or coughing up blood. The first steps in a mesothelioma diagnosis are usually ruling out other explanations, such as lung cancer or an infection.

Your doctor may have started with a chest X-ray, MRI or CT scan. You may have had bloodwork done or a needle aspiration to remove and test some of the fluid buildup in your mesothelium.

In most cases, your doctor isn’t able to give a conclusive mesothelioma diagnosis without a biopsy. A biopsy is a small operation to remove tissue from your tumor. That tissue is then examined under a microscope to determine what type of cancer you have.

Your initial mesothelioma diagnosis is just the beginning. Any time you want to participate in a mesothelioma clinical trial or find out if a targeted mesothelioma immunotherapy treatment will work with you, additional tests may be needed.

A newly approved diagnostic test from Foundation Medicine could change all that. The FoundationOneCDx  (F1CDx) cancer test screens for 324 genes that are known to be related to the growth of cancerous tumors. Rather than hit-or-miss testing for single genetic factors, this one screening could give doctors complete and detailed information about your mesothelioma tumor in their hands. This could get you to your best treatment faster and avoid unpleasant and unnecessary side effects from failed treatments.

At the moment, the FDA has approved the F1CDx test for five types of cancer: non-small cell lung cancer (NSCLC), melanoma, breast, cancer, colorectal cancer, and ovarian cancer. Mesothelioma patients are often helped by breakthrough treatments for other types of cancers, particularly non-small cell lung cancer and melanoma. For example, immunotherapy drug Keytruda, which was initially developed to treat NSCLC and melanoma, has had great results for some mesothelioma patients.

The FDA has approved the F1CDx test only for patients whose cancer is Stage IV or has metastasized or for a recurrent cancer. In other words, genomic testing and immunotherapy won’t replace first line mesothelioma treatments such as chemotherapy or surgery yet. But this diagnostic tool could represent an important advance in mesothelioma diagnosis for late-stage mesothelioma patients.

What is Gene Sequencing and Why is It Important to Mesothelioma Diagnosis?

Gene sequencing (more properly called DNA sequencing here) is an examination of the DNA molecule to unravel its genetic code. This code is spelled out in four nucleobases: adenine, guanine, cytosine, and thymine or A, G, C, and T. Our molecules use these four letters to program our bodies. Cancer cells use this language as well.

Genetic sequencing reveals the order that A, G, C, and T appear and repeat on a particular strand of DNA. It took many years for researchers at the Human Genome Project to decode the DNA sequences for the whole human genome. Since that feat was accomplished in 2003, the speed at which genes can be sequenced has gotten much faster.

The approval of the F1CDx test by the FDA and (soon) by Medicare brings gene sequencing within the reach of ordinary mesothelioma patients. Cancer researchers have predicted the rise of personalized medicine, where each patient and every tumor receives a treatment genetically tailored to be most effective.  F1CDx makes personalized medicine closer to reality.

Immunotherapy is changing the focus of oncology from how to treat a particular type of cancer, such as mesothelioma or lung cancer, to treatment based on the type of tumor. Immunotherapy treatments have brought hope to many people living with a mesothelioma diagnosis. Without better genetic testing, however, immunotherapy drugs are administered blindly. Better genetic testing is needed to use immunotherapy effectively.

F1CDx is the second test approved by the FDA to test for cancer mutations in multiple genes at once. More such tests are in the pipeline. That is good news for mesothelioma patients.

Mesothelioma Diagnosis and Mesothelioma Immunotherapy Clinical Trials

One way for mesothelioma patients to get access to cutting edge treatments is through mesothelioma clinical trials. Particularly for people who receive their mesothelioma diagnosis at a late stage or for whom conventional treatments don’t work, clinical trials represent a potential lifeline. However, because immunotherapy drugs are targeted to work on very specific genetic mechanisms, you might have to undergo additional testing just to find out if you are eligible to enroll in a clinical trial.

With comprehensive tests like F1CDx, your doctor may be able to compare the genetic makeup of your tumor against numerous clinical trials and zero in on a trial that is a good match for your genetics and your condition. This will help researchers find clinical trial participants and mesothelioma patients find clinical trials faster and more easily.

Medicare Coverage for F1CDx

AARP estimates that over 49 million Americans or about 15 percent of the population gets its health insurance through Medicare. Because mesothelioma develops slowly, most patients will get a mesothelioma diagnosis when they are over 65.

For the many mesothelioma patients on Medicare, the fact that Medicare plans to cover the F1CDx test, which costs about $6,000, is crucial. Many more mesothelioma patients will be able to receive this important test and, once Medicare covers a procedure, other insurance companies will often do the same.

Medicare coverage of the F1CDx diagnostic test is expected to start in 2018, after a comment period on the proposed coverage is complete.

Are you currently going through the process of acquiring a mesothelioma diagnosis? If you are a mesothelioma patient would you be willing to share your insights about the process of a mesothelioma diagnosis? Your voice on this issue is important. We look forward to sharing your insights with our readers. Please comment here, call, or email us with your concerns or insights.

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Amir Hussain

Amir Hussain is the founder of Freemium World, a geek by nature and a professional Blog writer . I love to write about new technology trends, social media, hacking, blogging and much more.

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