
Cancer Biomarker Awareness Day falls on Thursday, November 12, 2026. The observance centers on one step in cancer care that is easy to overlook: cancer biomarker testing, which looks for specific changes in a person's cancer that can help guide treatment and point toward clinical trials. Many people with cancer have never heard the term, and many who could benefit from testing do not receive complete testing at the right time.
This article explains what cancer biomarkers are, how testing works, and how results can shape clinical trial options.
Cancer Biomarker Awareness Day was first observed on November 13, 2025. It was started by a national lung cancer nonprofit working with a coalition of cancer advocacy organizations, and groups representing colorectal, ovarian, skin, and other cancers now take part. It is an advocacy-led observance rather than a government designation, and its date can shift from year to year.
The day recognizes the role biomarker testing plays in access to precision medicine, which means choosing treatment based on the features of a person's specific cancer rather than only on where in the body the cancer started. The message applies across cancer types: patients and families are encouraged to ask whether testing has been done and what the results mean.
The observance falls during Lung Cancer Awareness Month, which also focuses on lung cancer risks and screening. The overlap is fitting. In non-small cell lung cancer, the most common type, guidelines recommend testing for a broad set of biomarkers at diagnosis because several of them have matching treatments.
The day also exists because testing gaps remain. In one recent study of U.S. community oncology practices, roughly four in ten people with advanced non-small cell lung cancer did not receive the full set of guideline-recommended biomarker tests. Other studies show differences in testing by race, insurance type, and region. These gaps largely reflect system factors such as limited tissue, turnaround times, coverage, and where care is delivered.
A biomarker is a measurable sign of what is happening in the body. Federal health agencies define it as a characteristic measured as an indicator of normal biological processes, disease processes, or responses to a treatment. In cancer, biomarkers are genes, proteins, and other substances found in tumor cells or blood that give information about the cancer. Each person's cancer has its own pattern of biomarkers.
A cancer biomarker works like a label describing what is driving the cancer's growth. Two people may both have lung cancer, yet their tumors can carry different labels, and those labels may call for different treatments. Biomarkers are also used well beyond cancer, and it helps to understand how biomarkers work across medicine before focusing on tumors.
Cancer biomarkers are grouped by what they help doctors decide:
A single biomarker can play more than one role. Biomarker testing may also be called tumor testing, genomic testing, or molecular profiling.
Dozens of biomarkers are now part of routine cancer care. Gene and protein names look technical, but each describes a specific feature of the cancer. Commonly tested examples include:
Some of these biomarkers matter regardless of where the cancer started. A small and growing group of therapies (nine as of October 2026) is approved by the FDA based on a tumor's biomarker rather than its location in the body. This is called a tissue-agnostic approval.
Blood tests such as PSA (prostate-specific antigen) and CA-125 are often called tumor markers, but they work differently from the biomarkers above. Non-cancer conditions such as an enlarged prostate or endometriosis can raise them, so neither can diagnose cancer on its own. CA-125 is mainly used to monitor ovarian cancer treatment and check for its return, and a large randomized study found that screening the general population with it did not reduce ovarian cancer deaths. PSA screening is a shared decision between a person and their doctor.
Biomarker testing is usually ordered by the oncologist, and some hospitals start it automatically at diagnosis. Testing is commonly recommended for advanced cancer and at diagnosis for certain cancers, including non-small cell lung, breast, and colorectal cancer.
Testing uses one of two main sample types. A tissue sample comes from a biopsy or surgery. A liquid biopsy is a blood test that looks for circulating tumor DNA, the small fragments of DNA that tumors shed into the bloodstream. It can help when a tumor is hard to reach, but a negative result may need tissue confirmation because blood sometimes holds too little tumor DNA.
Labs use several methods, often in combination:
Some tests are reviewed by the FDA together with a specific medicine. This is called a companion diagnostic: the medicine is approved for patients whose test shows a certain biomarker, and the test is approved to find it.
Biomarker testing on a tumor looks for somatic changes, which develop during a person's lifetime, cause most cancers, and cannot be passed on to children. Inherited genetic testing looks for germline changes, which are present from birth in every cell and can be shared by relatives. Tumor testing sometimes reveals a possible inherited change, such as inherited BRCA1 and BRCA2 changes. In that case, a separate confirmatory test and a conversation with a genetic counselor are usually recommended.
The Genetic Information Nondiscrimination Act protects people from genetic discrimination in health insurance and employment. It does not cover life, disability, or long-term care insurance, so it is worth understanding these limits before inherited testing.
A biomarker report lists the changes found and any treatments or trials that may match them. A matching biomarker does not guarantee that a treatment will work, because not every cell in a tumor carries the same changes. Cancers can also change over time, so repeat testing may be recommended if a cancer grows or returns. Some reports list variants of uncertain significance, changes whose effect is not yet known and which are not used to choose treatment.
Many cancer clinical trials use biomarker results to decide who can join. Some trials require a specific change, such as a particular gene fusion, while others enroll only people whose cancer does not carry a targetable change. As a result, biomarker results can open some trial options and narrow others.
Biomarkers have also changed how trials are designed. A basket trial tests one treatment across several cancer types that share the same biomarker. An umbrella trial studies one cancer type and assigns participants to different treatments based on their biomarkers. A platform trial adds or drops treatment arms over time. These designs are explained in more detail in this overview of basket, umbrella, and platform trials.
Biomarker-defined groups can be very small. In one large federal precision medicine study, more people had a potentially actionable change than could actually be assigned to a matching treatment arm, and fewer than one in five of those screened were assigned. Rare biomarkers make it harder to find enough eligible participants, so these trials can take longer to fill.
For people exploring trials, keeping a copy of the biomarker report may help a study team review eligibility faster and may reduce the need for a repeat biopsy. Some trials require recent testing, and some cover the cost of biomarker testing as part of the study.
Coverage depends on the plan and the situation. Medicare covers next-generation sequencing for many people with advanced cancer when certain criteria are met. About half of U.S. states have passed laws requiring broader biomarker testing coverage by some health plans, though the details vary and self-funded employer plans are generally not affected. Checking with the insurer before testing is the most reliable approach.
Generally, no. Treatment-guiding biomarker tests are used after a cancer diagnosis. Multi-cancer early detection blood tests, which aim to find signs of several cancers in people without symptoms, are still being evaluated, and none had FDA approval as of November 2026.
This is a common result. It means no change with a matching approved treatment was found at the time of testing. Standard treatments remain available, and some trials enroll people without a targetable change.
Cancer Biomarker Awareness Day is a reminder that the details of a person's cancer can matter as much as its name. Asking about complete biomarker testing, keeping a copy of the report, and discussing results with the care team are practical steps that may open more options.
For people who want to explore clinical research, DecenTrialz is a clinical trial recruitment and pre-screening platform that helps connect people with relevant studies. Participants share some information about their health, are matched to trials that may fit, and a registered nurse reviews their information before a referral is sent to the research site.
DecenTrialz does not order or interpret biomarker tests or recommend treatment. The research site team makes all final eligibility decisions and handles informed consent and enrollment. To explore clinical trials that may match your situation, visit decentrialz.com.
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