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Lung Cancer

ROS1 Fusion Test - Lung Cancer Biomarker

This ROS1 fusion test detects ROS1 gene rearrangements in a patient’s tumor to identify eligibility for ROS1-targeted therapies. By enabling selection of effective targeted treatment, it can help avoid ineffective chemotherapy, unnecessary toxicity, and faster cancer progression.

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Key Insights

  • See whether your lung tumor carries a ROS1 gene fusion that drives growth and can change treatment options with your oncology team.
  • Identify the exact fusion partner and related tumor markers that help explain symptoms, staging, and risk of spread.
  • Learn how tumor genetics, smoking history, and sampling method can shape results and what they mean for your biology.
  • Use findings to guide targeted therapy decisions and clinical trial eligibility in partnership with your clinician.
  • Track changes over time to monitor response or emerging resistance using repeat tissue or plasma testing.
  • Integrate results with other panels such as EGFR, ALK, BRAF, KRAS, MET, RET, NTRK, PD-L1, and tumor mutational burden for a complete view of your cancer.

What Is a ROS1 Fusion Test?

A ROS1 fusion test detects when the ROS1 gene has become abnormally joined to another gene in a lung tumor. This rearrangement creates a hybrid “on switch” that can fuel cancer cell growth. Testing is performed on tumor tissue from a biopsy or surgical sample, or on plasma using circulating tumor DNA (a liquid biopsy). Laboratories commonly use next-generation sequencing to read DNA or RNA and identify fusion breakpoints, fluorescence in situ hybridization to visualize the rearrangement in cells, and sometimes immunohistochemistry as a screening tool. Results are reported as fusion positive or negative, often with the name of the partner gene (for example, CD74‑ROS1) and technical details like assay sensitivity and, in some reports, variant allele fraction.

This test matters because ROS1 fusions are potent drivers in a small but important subset of non‑small cell lung cancers. Finding a fusion provides objective, actionable information about the tumor’s biology and signaling pathways. It helps explain how the cancer is behaving, supports precision treatment planning, and offers a measurable target to follow over time. In short, it connects molecular changes inside cells to real‑world outcomes like symptom control, response to therapy, and long‑term resilience.

Why Is It Important to Test Your ROS1?

ROS1 is a receptor tyrosine kinase. When it fuses with another gene, the kinase can become stuck in an active state that continuously sends growth signals. In lung adenocarcinoma, this single event can act like a master key for unchecked cell division, survival, and spread. A ros1 fusion test tells you if this is the circuit your tumor is using. The finding is most relevant at diagnosis of advanced non‑squamous non‑small cell lung cancer, at recurrence, or if the cancer stops responding after a period of control. Although ROS1 fusions are uncommon overall, they are enriched in adenocarcinomas and in people who have never smoked or smoked lightly, but they can occur in anyone. The result is not inherited; it arises within the tumor itself.

Zooming out, precision oncology is about matching the right strategy to the right biology. Regular molecular testing lets you measure rather than guess. It can detect early warning signs that a treatment is no longer working, reveal new resistance mechanisms, and show when a different approach may make more sense. The goal is not to “pass” or “fail.” It is to understand what is driving the cancer at this moment and adjust with your care team to improve control, reduce side effects, and support longevity, ideally using the least amount of intervention needed for the most benefit.

What Insights Will I Get From a ROS1 Fusion Test?

Reports typically state positive or negative for a ROS1 rearrangement. Some assays include the fusion partner, the exact breakpoints, and a quantitative estimate such as variant allele fraction in tissue or plasma. Laboratories set internal thresholds for calling a fusion, and results are interpreted against these cutoffs. In this context, “normal” means no fusion detected on that sample, while “positive” indicates a ROS1‑driven signaling pathway that may be targetable. Context matters: sample quality, tumor content, and the technology used can influence detection.

If no fusion is found, it suggests your tumor is powered by different pathways, and other drivers should be evaluated. If a fusion is present, it indicates oncogenic ROS1 activity that can shape treatment decisions with your oncologist. Variation in quantitative metrics can reflect tumor heterogeneity, prior therapy, or the proportion of tumor DNA in the sample.

Higher or lower allele fractions do not map cleanly to “better” or “worse.” A low fraction in plasma may simply reflect limited DNA shedding into the bloodstream. Likewise, immunohistochemistry signal intensity does not replace molecular confirmation. A positive result does not diagnose cancer on its own; it adds a precise layer of biology to a diagnosis already established by imaging and pathology.

The real power is in pattern recognition over time. In tissue, fusion status anchors first‑line planning. In plasma, repeat testing can help track response or reveal resistance alterations that emerge under treatment. When integrated with other biomarkers and your clinical picture, these patterns support earlier detection of change and more personalized planning.

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Frequently Asked Questions About

What do ROS1 fusion tests measure?

ROS1 fusion tests detect whether a cancer harbors a rearrangement that joins the ROS1 kinase gene to another gene, producing an abnormal fusion protein with constitutive (always‑on) kinase activity that can drive tumor growth; in other words, they measure the presence of ROS1 gene fusions as a tumor biomarker.

Depending on the assay, the test measures the rearrangement at the DNA level (FISH), the fusion transcript at the RNA level (RT‑PCR or RNA‑based NGS), or ROS1 protein expression (IHC); results are used to identify patients likely to benefit from ROS1‑targeted therapies rather than to quantify overall tumor burden or detect other non‑fusion alterations.

How is your ROS1 fusion sample collected?

Samples for ROS1‑fusion testing are typically collected either from tumor tissue or from blood. Tissue is obtained during a diagnostic biopsy or surgical resection and is usually preserved as formalin‑fixed, paraffin‑embedded (FFPE) blocks or fresh/frozen material; small sections or extracted nucleic acids from that tissue are used for molecular assays (NGS, RT‑PCR, or FISH) to detect ROS1 fusions.

Alternatively, a liquid biopsy is done by a standard blood draw into tubes that preserve plasma; the plasma is separated and circulating tumor DNA (ctDNA) or cell‑free nucleic acids are analyzed by molecular methods to look for ROS1 fusions. Collection is performed by trained healthcare staff following the test kit or laboratory instructions to ensure sample integrity for accurate testing.

What can my ROS1 fusion test results tell me about my cancer risk?

A positive ROS1 fusion test means a ROS1 gene rearrangement was detected in the sample you provided — either in tumor tissue or circulating tumor DNA. That finding indicates the presence of cells carrying a ROS1-driven mutation and is commonly associated with certain cancers (most notably a subset of non‑small‑cell lung cancers). It is an indicator of a ROS1‑positive tumor rather than a measure of your general lifetime cancer risk.

A negative result means no ROS1 fusion was found in the tested sample but does not rule out cancer or other oncogenic alterations. Test sensitivity, the type of sample (tissue vs. blood), and tumor burden affect results; higher levels of ROS1 signal in blood can suggest more tumor DNA but don’t precisely quantify tumor size. Interpret results with your clinician, who will combine them with imaging, pathology and other tests to determine diagnosis and next steps.

How accurate or reliable are ROS1 fusion tests?

ROS1 fusion testing is generally reliable when performed with validated, clinically accredited methods: RNA-based next‑generation sequencing (NGS) and fluorescence in situ hybridization (FISH) are highly sensitive and specific for detecting actionable ROS1 rearrangements, while immunohistochemistry (IHC) is a useful, high‑sensitivity screening tool but often requires molecular confirmation of positives. A properly designed RNA NGS assay typically provides the best ability to detect a wide range of fusion partners and breakpoints.

How often should I test my ROS1 fusion levels?

Test for a ROS1 fusion at initial diagnosis of non–small cell lung cancer to guide targeted therapy, and repeat testing if the cancer progresses, relapses, or if your doctor suspects resistance to therapy—these are the most important times to reassess ROS1 status.

Routine repeat tumor biopsies while you are clearly responding are not usually required; however, many clinics use circulating tumor DNA (liquid) testing or repeat tissue testing when imaging or symptoms suggest change. The exact frequency is individualized based on treatment, response, and clinical course, so discuss a monitoring schedule with your oncologist (they may align testing with routine imaging visits).

Are ROS1 fusion test results diagnostic?

No — ROS1 fusion test results highlight patterns of imbalance or resilience at the molecular level and are not themselves a medical diagnosis. They must be interpreted by a qualified clinician alongside symptoms, medical history, imaging, and other laboratory or biomarker data to determine clinical significance and guide next steps.

How can I improve my ROS1 fusion levels after testing?

You can't "improve" a ROS1 fusion level the way you would a lab value—ROS1 fusions are genomic alterations in the tumor that either are present or not. If your test result is positive, that is usually a treatment biomarker rather than something to change with lifestyle; if the result is negative but clinical suspicion remains, the appropriate actions are repeat or orthogonal testing (e.g., comprehensive NGS panel, FISH, RT‑PCR, or liquid biopsy) and review of sample quality and testing method with your care team.

Practically, discuss the result promptly with a medical oncologist or molecular tumor board: confirmatory testing, consideration of ROS1‑targeted therapies or clinical trials if positive, and planned monitoring (imaging and/or serial ctDNA) if treated or under observation are typical next steps. Seek a second opinion at a specialist center if needed; do not attempt to alter fusion status with unproven supplements or lifestyle changes.

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