Nucleix

Company Overview

Snapshot

Founded in May 2008 by Adam Wasserstrom and Danny Frumkin, Nucleix operates with 51–200 employees. The company has raised $88.3M across 5 funding rounds from 11 investors. In May 2023, Nucleix's Bladder EpiCheck® received FDA 510(k) Clearance for monitoring non-muscle invasive bladder cancer recurrence.

Business overview

Nucleix is a liquid biopsy company focused on revolutionizing cancer treatment through earlier disease detection. The company leverages NGS-based and PCR-based technology to identify methylation changes, providing a pioneering approach for early-stage and recurring cancer detection. Its non-invasive EpiCheck® platform delivers accurate and sensitive results, offering a seamless testing option for physicians, patients, and the healthcare system. Nucleix is building an EpiCheck® franchise, starting with the Bladder EpiCheck® kit, which is CE-marked and available in Europe for primary and recurrent bladder cancer and upper tract urinary cancer, and FDA 510(k) cleared for bladder cancer recurrence in the United States. The company is also advancing its Lung EpiCheck® test for high-risk individuals and evaluating additional tests for other high-risk diseases, operating within the Health Tech & Life Sciences sector.

Strategic signal

In May 2023, Nucleix received FDA 510(k) Clearance for its Bladder EpiCheck® for monitoring non-muscle invasive bladder cancer (NMIBC) recurrence. This regulatory milestone is a significant validation of the company's technology and opens up the crucial US market, signaling strong commercial potential and increased adoption within the healthcare system for non-invasive cancer detection solutions.

Company Intelligence Q&A

What is Nucleix's core focus?

Nucleix is a liquid biopsy company dedicated to the early detection of cancer through non-invasive testing, aiming to improve treatment outcomes by identifying disease at an earlier stage.

What was a key regulatory achievement for Nucleix in 2023?

In May 2023, Nucleix's Bladder EpiCheck® received FDA 510(k) Clearance for monitoring non-muscle invasive bladder cancer (NMIBC) recurrence, expanding its market access in the United States.

Which of Nucleix's products is available in Europe?

Nucleix's Bladder EpiCheck® kit is CE-marked and available in Europe for primary and recurrent bladder cancer and upper tract urinary cancer.

What is the status of Nucleix's Lung EpiCheck® test?

Nucleix is advancing its Lung EpiCheck® test towards commercialization for high-risk individuals, as highlighted in April 2023 when the company premiered data on its EpiCheck® Lung Cancer Atlas at the American Association for Cancer Research Annual Meeting.