Regulatory status | SpotitEarly

ABOUT / Regulatory status

Product development status

Our innovative breath-based cancer detection test is constantly under development and validation and has shown promising results in a large-scale observational clinical trial.

The SpotitEarly tests have not been approved yet by the Food and Drug Administration (FDA) and are currently under development and validation.

We are actively pursuing regulatory approval to bring this solution to a commercial phase.

Our follow-up clinical studies, the Pink study and the White study, offer additional substantial clinical validation for the product and method we employ. These meticulously designed and executed studies build upon the foundation of our initial research, further solidifying the efficacy and safety of our product.

Our CLIA-registered laboratory is equipped with state-of-the-art technology and staffed by highly trained and experienced professionals. We follow strict protocols to ensure that our tests are performed accurately and reliably.

We at SpotitEarly are committed to saving lives and improving clinical outcomes for everyone, everywhere.

We at SpotitEarly

are committed to saving lives and improving clinical outcomes

for everyone

everywhere

We at SpotitEarly are committed to saving lives and improving clinical outcomes for everyone, everywhere.

Our Values

Why can’t all people around the world adopt regular, hassle-free cancer pre-screening at home, and enjoy life to the fullest?

Currently, despite billions spent on cancer screening, nearly half of the cases are still not detected early enough.

Victory over cancer requires a fresh approach. We looked to nature, with its remarkable capabilities and resilience, and combined it with the power of artificial intelligence.

SpotitEarly’s technology allows more frequent testing of much wider audiences at a fraction of the cost.

We’re bringing the learning power embedded in our system to the forefront of the race against cancer.

Compassion

All humans deserve a better chance at life, and to be spared unnecessary suffering. We strive to preserve their dignity, independence and right to good health.

Accuracy

We uphold the highest standards of reliability, fundamental to our work. Precision and effectiveness in our solutions will lead to better outcomes for individuals.

Innovation

We continuously push the limits of technology to develop cutting-edge solutions for early detection. Only with disruption can we meet new challenges and deliver impactful results.

Canine Care

We truly care for our 4-legged partners’ wellbeing. We provide them the best nutrition, space to exercise, playtime, tons of love, warmth, and their favorite goodies.