For laboratories
Your urologist relationships already exist. The clinical ordering framework converts them to 104-gene ctDNA panel orders.
Regional reference labs with existing CLIA certification, CAP accreditation, and NGS infrastructure run the 104-gene ctDNA panel under their existing CLIA number. Atumnus delivers the clinical ordering framework, gene-to-therapy matrix, and pharma sponsor channel. No new physician acquisition. No new capital expenditure. Revenue participation terms are established in the signed lab participation agreement.
How the partnership works
Specimen to enrolled patient — three steps.
01
Lab processes the specimen
Blood draw ordered by urologist. Lab runs 104-gene ctDNA panel on existing NGS infrastructure under existing CLIA number. No new equipment. No new certification.
02
Atumnus delivers the framework
Clinical ordering framework, gene-to-therapy matrix, and VerifiedEnroll integration. Atumnus provides the bioinformatics pipeline. Lab provides the assay.
03
Sponsor-funded companion diagnostic channel
Companion diagnostic testing channel activates for matched Atumnus-registered studies. Sponsor-direct compensation outside Medicare billing. Lab participation agreement governs payment structure.
Panel specifications
104-gene ctDNA panel.
Genes
104-gene ctDNA
Indications
Prostate · Bladder · RCC
Sensitivity
0.1% VAF
Sample type
Blood draw only
Billing
Standard NGS CPT codes
Certification
Existing CLIA
FAQ
Lab partnership questions.
Does Medicare cover the panel?
The pharma sponsor channel operates outside Medicare billing. The panel may be billed through standard NGS CPT codes depending on clinical indication. Atumnus provides a billing framework as part of the partnership.
What is the lab participation agreement?
Revenue participation terms are established in the signed lab participation agreement. Companion diagnostic compensation is governed by a separate sponsor agreement instrument. Terms provided upon application.
What CLIA requirements apply?
Labs must hold existing CLIA certification for NGS-based oncology testing. No new certification required. The lab runs the assay under its existing CLIA number.
What is the timeline to first panel revenue?
60–90 days from signed partnership agreement to first panel revenue. Bioinformatics integration, ordering framework deployment, and physician communication infrastructure. Pharma sponsor channel activation runs in parallel.
Apply
Lab partnership application
Applications reviewed within 5 business days. Labs with existing NGS oncology certification are reviewed first.