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, with Sands Capital leading a January 2022 round. 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 healthcare providers and patients. Nucleix is building an EpiCheck® franchise, starting with the Bladder EpiCheck® kit, which is CE-marked in Europe and FDA 510(k) cleared in the United States. The company is also advancing its Lung EpiCheck® test and evaluating additional tests for other high-risk diseases, operating within the Health Tech & Life Sciences sector, specifically in Pharma & Medical Biotechnology and Test Diagnostics & Screening.

Strategic signal

In May 2023, Nucleix received FDA 510(k) clearance for its Bladder EpiCheck® for monitoring of non-muscle invasive bladder cancer (NMIBC) recurrence. This regulatory approval is a significant validation of the company's technology and expands its market access in the United States, indicating strong commercial momentum and a clear path for broader adoption of its 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.