PGDx elio tissue complete enables you to confidently advise your oncologists and gain new research advantages with our sample-to-answer IVD kit that includes fully automated bioinformatics and dedicated customer support.
PGDx elio™ tissue complete
The first and only FDA-cleared marked tumor profiling kitted solution
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PGDx elio TISSUE COMPLETE
Product overview
Benefits of the PGDx pan solid tumor CGP test
Our test, your lab
Offer rapid comprehensive, scalable genomic testing and report on actionable findings with confidence with 5 day* turnaround from isolated nucleic acid to variant report.
Accelerate your path to test launch and reimbursement
FDA-cleared and CE-marked solution allows for verification, not validation. Professional services available with dedicated implementation project management with custom script development enables seamless integration. Go-live in 6 weeks.
Enable new opportunities
Activate new research opportunities and unlock new potential paths to reimbursement.
505
Gene panel with TMB and MSI
35
Solid tumor types
FDA-cleared
CE-marked
5
Days from isolated nucleic acid to variant report*
6
Weeks to go live
30M+
People covered for Medicare reimbursement
*Kitted workflow plus pipeline output. Not inclusive of DNA extraction and downstream processing
Backed by robust bioinformatics
TESTIMONIALS
Market leaders choose PGDx elio™ tissue complete
As an FDA-cleared IVD, PGDx elio tissue complete offers immense value to my lab as it requires only verification, instead of validation. This enables a clear path to reimbursement and eliminates the need to find another 3rd party for reporting, thus speeding up my lab’s testing capabilities.
The PGDx team provided excellent project management during the onboarding and implementation process, allowing for only 196 days from contract signed to first patient report.
The FDA-cleared IVD kit offered immense value to my lab as it enabled a verification instead of full validation, a straight path to reimbursement and eliminated the need of a third party vendor to generate reports.
TECHNICAL INFORMATION
PGDx elio tissue complete product specs
This test identifies somatic mutations with high accuracy and sensitivity, providing information on single nucleotide variants (SNVs), insertions/deletions (indels), amplifications, translocations, microsatellite instability (MSI) status and tumor mutation burden (TMB) for use by qualified professionals to guide treatment decisions.
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Patent Disclaimer
For In Vitro Diagnostic Use.
Personal Genome Diagnostics Inc. (PGDx) is a subsidiary of Laboratory Corporation of America Holdings, using the brand Labcorp.
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