From Promising Results to Practice: How SpotitEarly Is Building the Evidence for its Breath-Based Cancer Screening

By SpotitEarly Team · July 2026 · 4 min read

A cancer screening test can identify a potential cancer signal in minutes. Demonstrating that the test truly saves people's lives takes years.

Our promising results :

The company is investing heavily in generating the evidence behind its non-invasive breath-based approach to multiple cancer early detection. SpotitEarly double-blind Rainbow Study already reported 93.9% sensitivity and 94.3% specificity across 4 major cancers. 

What Makes a Good Screening Test?

Detecting cancer is only the beginning. Before any new technology can become part of routine healthcare, researchers must show that it is accurate, reliable, safe, and ultimately capable of helping patients.

Researchers evaluate measures such as sensitivity, which reflects how often the test correctly identifies people with cancer, and specificity, which measures how often it correctly identifies people without cancer. These measures matter because false results can have consequences :

• A false positive occurs when a test suggests cancer may be present even though no cancer is found. This can lead to additional imaging or diagnostic procedures and unnecessary anxiety.

• A false negative occurs when a test misses a cancer that is present. In screening, minimizing false negatives is particularly important because missed cancers may delay diagnosis and treatment.

  
  

The goal of every screening technology is therefore to detect as many cancers as possible while minimizing unnecessary follow-up for people who do not have cancer.

Why Large-Scale Validation Matters

Accuracy alone is not enough. Screening tests are used in people who often feel healthy, so they must also perform reliably in large asymptomatic populations.

Researchers evaluate additional measures such as positive predictive value (PPV), determine how often unnecessary follow-up testing occurs, and assess whether positive results can be investigated efficiently and safely.

Ultimately, the most important question is whether using the test actually improves patient outcomes. As the National Cancer Institute explains, prospective clinical trials are needed to determine whether MCED tests detect cancer early enough to reduce mortality while minimizing overdiagnosis and unnecessary procedures. Even a small false-positive or false negative rate can affect thousands of people when a test is used across millions of patients, potentially leading to avoidable anxiety, additional costs, and unnecessary follow-up procedures.

The Clinical and Regulatory Journey of MCED Tests

Here is the big pictures for MCED screening technologies to become part of routine health care:

Technical Validation: Studies first assess whether the test can consistently and reliably measure the biological signal it is designed to detect. This includes analytical validity and early performance testing.

Clinical Validation: Prospective studies that evaluate how accurately the test performs in the intended-use population. These studies establish measures such as sensitivity, specificity, and predictive value under real-world screening conditions.

Regulatory review: Once performance is established and ready for regulatory review, the test may be implemented as a Laboratory Developed Test (LDT) in a CLIA-certified laboratory, where it must meet laboratory quality requirements. Developers may also pursue FDA authorization, where appropriate, to support broader clinical adoption and reimbursement opportunities for the product.

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Today, no MCED test has yet received FDA clearance or approval. Some, including GRAIL's Galleri and Exact Sciences' Cancerguard, are currently offered as LDT performed in CLIA-certified laboratories while continuing to generate clinical evidence and pursue FDA authorization.

SpotitEarly's Validation Journey

SpotitEarly is following this same evidence-based pathway.

Our prospective double-blind Rainbow Study evaluated breath samples from 1,386 participants and reported 93.9% sensitivity and 94.3% specificity across breast, lung, colorectal, and prostate cancers, with 94.8% sensitivity for Stage I–II disease.

Building on these findings, SpotitEarly is now expanding validation through double-blind prospective studies :

• Breast cancer : PINK Study, evaluating breath-based breast cancer screening in the intended-use population in collaboration with Hackensack Meridian Health

• Lung cancer : WHITE Study, evaluating breath-based lung cancer detection in the intended-use population.

  
  

Together, these studies represent the next stage in assessing how the technology performs in real-world screening settings and how it can fit responsibly into future screening programs.

Why the Process Takes Years

Generating meaningful evidence cannot be rushed.

Demonstrating that a screening test reduces cancer mortality requires following thousands of participants over many years. Researchers must compare screened and unscreened populations, monitor long-term outcomes, and determine whether earlier detection truly changes survival.

The development of other MCED technologies illustrates this reality. GRAIL's Galleri test received FDA Breakthrough Device designation in 2018 and submitted its Pre Market Approval application in 2026 after years of clinical studies and continued follow-up.

This lengthy process is not a regulatory obstacle. It is what gives physicians, patients, and healthcare systems confidence that a new screening technology genuinely benefits the people it is designed to help.

Building the Future of Cancer Screening

The future of cancer screening will likely include multiple complementary technologies, each relying on different biological signals. Blood, breath, imaging, and other emerging approaches share the same objective: finding cancer earlier and improving patient outcomes.

At SpotitEarly, our breath-based platform is following this evidence-driven path through prospective clinical studies and larger intended-use validation, with the long-term goal of bringing a clinically validated breath test to patients.

Developing a new cancer screening test takes time, but every step serves the same purpose: ensuring that patients can trust their results because they are supported by rigorous science, careful validation, and meaningful clinical evidence.

SpotitEarly's breath-based test is designed to complement recommended cancer screening programs, not replace them. A positive screening result is not a cancer diagnosis, and all follow-up decisions should be made with a qualified healthcare provider.