Nucleix

Company Overview

Snapshot

Founded in May 2008 by Adam Wasserstrom and Danny Frumkin, Nucleix operates with 51–200 employees. The company has raised $88.3 million 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 (NMIBC) 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 non-invasive approach for early-stage and recurring cancer detection. Nucleix serves the healthcare industry with its EpiCheck® franchise, including the Bladder EpiCheck® kit, which is CE-marked in Europe and FDA 510(k) cleared in the United States, and the Lung EpiCheck® test, which is advancing towards commercialization for high-risk individuals. The company operates within the Health Tech & Life Sciences sector, specifically in Pharma & Medical Biotechnology, with a focus on Test Diagnostics & Screening.

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 approval is a significant validation of the company's technology and expands its market access in the United States, signaling strong commercial momentum and the potential for broader adoption of its non-invasive cancer detection solutions.

Company Intelligence Q&A

What was a significant regulatory milestone for Nucleix's Bladder EpiCheck?

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

When did Nucleix receive CAP Accreditation and CLIA Certification for its San Diego clinical laboratory?

In October 2022, Nucleix received CAP Accreditation and CLIA Certification for its San Diego clinical laboratory, enhancing its operational capabilities and credibility.

What was a key development for Nucleix's Lung EpiCheck® test?

In October 2020, a study published in the European Respiratory Journal demonstrated that Nucleix's Lung EpiCheck® liquid biopsy test detected 85% of early-stage lung cancers in high-risk smokers.

When was the Bladder EpiCheck® included in the European Association of Urology (EAU) Clinical Guidelines?

In March 2022, the Bladder EpiCheck® was included in the 2022.