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Regulation

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

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

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

A cancer test can flag a signal in minutes, but proving it helps patients takes years. This post explains what makes a good screening test, the validation and regulatory journey MCED tests follow, and how SpotitEarly is building the evidence behind its breath-based platform.

SpotitEarly Team

Jul 284 min read

CLIA Certification Explained: How SpotitEarly Ensures Trusted Cancer Detection

CLIA Certification Explained: How SpotitEarly Ensures Trusted Cancer Detection

CLIA Certification Explained: How SpotitEarly Ensures Trusted Cancer Detection

Obtaining and maintaining a CLIA certificate is required for laboratories that perform high complexity testing in the United States. This article explains what CLIA oversight involves and how SpotitEarly complies with these standards in its CLIA-registered lab. By meeting federal requirements for quality and accuracy, SpotitEarly ensures its Laboratory Developed Tests are performed in a safe, reliable, and clinically valid manner.

SpotitEarly Team

Nov 19, 20252 min read

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ALL RIGHTS RESERVED,
SPOTITEARLY 2025

TERMS & CONDITIONS

CLIA registration: 99D2307137

USPTO patent pending: WO2023239834A1

hello@SpotitEarly.com

ALL RIGHTS RESERVED,
SPOTITEARLY 2026

SpotitEarly tests are not intended to replace current screening procedures, but rather to be used as an additional pre-screening layer to complement preventative protocols already in place.

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

DISCLAIMER

THE [OFFERING MATERIALS] MAY CONTAIN FORWARD-LOOKING STATEMENTS AND INFORMATION RELATING TO, AMONG OTHER THINGS, THE COMPANY, ITS BUSINESS PLAN AND STRATEGY, AND ITS INDUSTRY. THESE FORWARD-LOOKING STATEMENTS ARE BASED ON THE BELIEFS OF, ASSUMPTIONS MADE BY, AND INFORMATION CURRENTLY AVAILABLE TO THE COMPANY’S MANAGEMENT. WHEN USED IN THE OFFERING MATERIALS, THE WORDS “ESTIMATE,” “PROJECT,” “BELIEVE,” “ANTICIPATE,” “INTEND,” “EXPECT” AND SIMILAR EXPRESSIONS ARE INTENDED TO IDENTIFY FORWARD-LOOKING STATEMENTS, WHICH CONSTITUTE FORWARD LOOKING STATEMENTS. THESE STATEMENTS REFLECT MANAGEMENT’S CURRENT VIEWS WITH RESPECT TO FUTURE EVENTS AND ARE SUBJECT TO RISKS AND UNCERTAINTIES THAT COULD CAUSE THE COMPANY’S ACTUAL RESULTS TO DIFFER MATERIALLY FROM THOSE CONTAINED IN THE FORWARD-LOOKING STATEMENTS. INVESTORS ARE CAUTIONED NOT TO PLACE UNDUE RELIANCE ON THESE FORWARD-LOOKING STATEMENTS, WHICH SPEAK ONLY AS OF THE DATE ON WHICH THEY ARE MADE. THE COMPANY DOES NOT UNDERTAKE ANY OBLIGATION TO REVISE OR UPDATE THESE FORWARD-LOOKING STATEMENTS TO REFLECT EVENTS OR CIRCUMSTANCES AFTER SUCH DATE OR TO REFLECT THE OCCURRENCE OF UNANTICIPATED EVENTS.

AN OFFERING STATEMENT REGARDING THIS OFFERING HAS BEEN FILED WITH THE SEC. THE SEC HAS QUALIFIED THAT OFFERING STATEMENT, WHICH ONLY MEANS THAT THE COMPANY MAY MAKE SALES OF THE SECURITIES DESCRIBED BY THE OFFERING STATEMENT. IT DOES NOT MEAN THAT THE SEC HAS APPROVED, PASSED UPON THE MERITS OR PASSED UPON THE ACCURACY OR COMPLETENESS OF THE INFORMATION IN THE OFFERING STATEMENT. YOU MAY OBTAIN A COPY OF THE OFFERING CIRCULAR THAT IS PART OF THAT OFFERING STATEMENT FROM:

https://www.manhattanstreetcapital.com/offering-circular/36138

SAFE HARBOR STATEMENT

Matters discussed in this website contain forward-looking statements. When used in this update, the words "anticipate," "believe," "estimate," "may," "intend," "expect" and similar expressions identify such forward-looking statements. Actual results, performance or achievements could differ materially from those contemplated, expressed or implied by the forward-looking statements contained herein. These forward-looking statements are based largely on the expectations of the Company and are subject to a number of risks and uncertainties. These include, but are not limited to, risks and uncertainties associated with our history of losses and our need to raise additional financing, the acceptance of our products and technology in the marketplace, our ability to demonstrate the commercial viability of our products and technology and our need to increase the size of our organization. Further information on the Company's risk factors is contained in the Company's Private Offering Memorandum. The Company undertakes no obligation to revise or update publicly any forward-looking statements for any reason except as may be required under applicable law.

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