Company Profile
Naveris, Inc. is a US-based precision oncology diagnostics company and liquid biopsy test manufacturer, headquartered in Waltham, Massachusetts, USA. Founded in 2017 by Dr. Piyush B. Gupta and Dr. Philip Haydon, the company operates as an independent private entity pending acquisition by CareDx, Inc. (Nasdaq: CDNA), serving global oncology markets with a proprietary blood-based monitoring platform for viral-mediated cancers.
Core Products ＆ Technologies
NavDx Liquid Biopsy Platform
• NavDx® TTMV-HPV DNA Test: Proprietary blood test detecting tumor tissue-modified viral (TTMV) HPV DNA fragments circulating in the bloodstream; supports post-treatment molecular residual disease (MRD) surveillance in HPV-driven cancers
• Digital Droplet PCR (ddPCR) Technology: Quantitative ddPCR assay analyzing circulating TTMV-HPV DNA with high analytical specificity and sensitivity
• HPV Genotype Detection: Identifies prevalent high-risk HPV genotypes including HPV-16, HPV-18, HPV-31, HPV-33, and HPV-35
Clinical Laboratory Services
• High-Complexity CLIA Laboratories: CAP-accredited and CLIA-certified clinical laboratories in Massachusetts and North Carolina, additionally accredited by the New York State Department of Health Wadsworth Center
• Patient Access Support: Naveris Cares™ financial assistance program and dedicated billing team for insurance navigation and appeals
Market Position ＆ Certifications
Naveris holds a pioneering position in viral-mediated cancer liquid biopsy, competing with Guardant Health (Shield MCD) and Exact Sciences (Cologuard) in blood-based cancer screening. Key strengths include:
• 9 years of US precision oncology diagnostics heritage since founding
• Medicare reimbursement: First and only Medicare-covered MRD test for HPV-driven anal squamous cell carcinoma (ASCC, November 2025); covered for head and neck cancer since August 2023; CMS ADLT designation (CPT 0356U)
• Clinical validation: Demonstrated ≥97% specificity and ≥89% sensitivity for oropharyngeal squamous cell carcinoma; 98% PPV and 95% NPV for ASCC recurrence detection in multicenter studies
• Commercial scale: 130,000+ tests performed supporting 40,000+ patients across all 50 U.S. states; 2,000+ active ordering physicians
• Reimbursement rate: ADLT reimbursement at approximately $1,800 per test
Corporate Timeline
2017 — Founded in Waltham, Massachusetts, USA, as a portfolio company of B-FLEXION Life Sciences
2023 — NavDx received Medicare coverage for HPV-driven head and neck cancer MRD surveillance
2024 — CMS designated NavDx as an Advanced Diagnostic Laboratory Test (ADLT, CPT 0356U); California Blue Shield established commercial coverage
2025 — Medicare expanded coverage to HPV-driven anal cancer (ASCC, November); unaudited revenue reached $34 million with 65% gross margins; Q1 2026 revenue approximately $12 million
2026 — CareDx announced definitive agreement to acquire Naveris for up to $260 million ($160M upfront + $100M milestones, April); transaction expected to close in Q3 2026
Target Markets ＆ Applications
• Head ＆ Neck Cancer MRD: NavDx surveillance for recurrence of HPV-driven oropharyngeal and head and neck squamous cell carcinoma post-surgery or post-chemoradiation
• Anal Cancer MRD: NavDx monitoring for molecular residual disease in HPV-driven anal squamous cell carcinoma, resolving ambiguous surveillance findings
• Gynecologic Cancer (Development): Ongoing development program for HPV-driven cervical and other gynecologic malignancies
• Clinical Workflow Integration: Blood-based alternative to imaging and tissue biopsy for longitudinal patient management from diagnosis through post-treatment surveillance
Contact Information
Global Headquarters
Address: 21 Hickory Drive, Suite 600, Waltham, MA 02451, USA
Telephone: (833) 628-3747
Email: billing@naveris.com
Website: naveris.com
Parent Company (Pending Acquisition)
CareDx, Inc.
Address: 5050 N. First Street, San Jose, CA 95134, USA
Stock: Nasdaq: CDNA
Website: caredx.com
Investor Relations: investors.caredx.com
