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TEST:
PGDx elio™ tissue complete assay

Company:
LabCorp
Type:
FDA Approved
Related tests:
Evidence

News

7ms
Comprehensive NGS profiling to enable detection of ALK gene rearrangements and MET amplifications in non-small cell lung cancer. (PubMed, Front Oncol)
"TMB was also assessed by the assay and correlated to the presence of NSCLC driver alterations and was found to be significantly lower in cases with NGS-confirmed canonical driver mutations compared with those without (p=0.0019). Overall, this study validates NGS as an accurate approach for detecting structural variants while also highlighting the need for further optimization to enable harmonization across methodologies for amplifications."
Journal
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ALK (Anaplastic lymphoma kinase) • MET (MET proto-oncogene, receptor tyrosine kinase)
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ALK positive • MET amplification • ALK rearrangement
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PGDx elio™ tissue complete assay
7ms
Laboratory Automation of PGDx elioâ„¢ Tissue Complete on the Biomek NGeniuS System Enables Accurate and Reproducible Comprehensive Genomic Profiling (AMP 2023)
Utilizing the newly developed automated workflow on the Biomek NGeniuS produced accurate and reproducible results and reduced user hands-on time and touchpoints. Variant detection across all variant classes was also highly concordant between the manual and automated workflows. Taken together, these data demonstrate the Biomek NGeniuS system can be successfully implemented to perform laboratory automation of PGDx ETC, maintaining analytical performance with reduced user intervention.
PGDx elio™ tissue complete assay
7ms
Tumor Diagnosis Re-Classification Based on Comprehensive Molecular Profiling Results Helps Guide Precision Medicine Strategy for Cancer Patients (AMP 2023)
Precision medicine relies on the ability to accurately identify cancer mutations through comprehensive diagnostic approaches including tumor genomic profiling. NGS not only facilitates this requisite but can also be applied to confirm cancer diagnoses or case re-evaluations where genomic findings are inconsistent with initial pathological review. This case series expands the value of CGP beyond biomarker detection for therapy selection, and highlights the justification of its use in diagnosis confirmation and tumor characterization.
Clinical • Tumor mutational burden
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TMB (Tumor Mutational Burden) • MSI (Microsatellite instability)
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PGDx elio™ tissue complete assay
9ms
Quantification and Analysis of CHIP/CCUS-Associated Mutations Identified in Solid Tumor Molecular Analyses (CAP 2023)
CHIP and CCUS play important roles as precursors to hematopoietic malignancies. Consequently, we characterized the population with solid tumor malignancies for mutations suspicious for CHIP/CCUS. Although <2% of our cohort demonstrated variants at time of diagnosis/recurrence, these may be significant in determining treatment options in the future.
DNMT3A (DNA methyltransferase 1) • SF3B1 (Splicing Factor 3b Subunit 1) • ASXL1 (ASXL Transcriptional Regulator 1) • TET2 (Tet Methylcytosine Dioxygenase 2) • BCOR (BCL6 Corepressor) • EP300 (E1A binding protein p300) • PTPRT (Protein tyrosine phosphatase receptor type T) • BCORL1 (BCL6 Corepressor Like 1)
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TET2 mutation
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PGDx elio™ tissue complete assay
10ms
Impact of baseline molecular alterations on the efficacy of tucatinib (TUC) plus trastuzumab (Tras) for HER2+, RAS WT metastatic CRC (mCRC) in MOUNTAINEER (ESMO 2023)
Conclusions This exploratory analysis of the MOUNTAINEER trial found generally consistent clinical efficacy of TUC + Tras to the primary analysis across subsets of pts w/ HER2+ RAS-WT mCRC and other clinically relevant genomic alterations. Table: 551O cORR DOR n % 95% CI n Months 95% CI Mutations Tissue NGS 45 46.7 31.7 – 62.1 21 15.3 8.9 – 25.5 ERBB2 6 66.7 22.3 – 95.7 - APC 36 44.4 27.9 – 61.9 16 16.6 6.1 – NE TP53 40 45.0 29.3 – 61.5 18 16.6 8.9 – NE ctDNA NGS 66 39.4 27.6 – 52.2 26 12.4 8.3 – 20.5 PIK3CA 7 28.6 3.7 – 71.0 - ERBB2 15 46.7 21.3 – 73.4 7 11.4 6.1 – NE APC 37 45.9 29.5 – 63.1 17 15.3 6.2 – NE Amplifications Tissue NGS 45 46.7 31.7 – 62.1 21 15.3 8.9 – 25.5 ERBB2 44 47.7 32.5 – 63.3 21 15.3 8.9 – 25.5 BRCA2 5 80.0 28.4 – 99.5 - ctDNA NGS 66 39.4 27.6 – 52.2 26 12.4 8.3 – 20.5 BRAF 7 14.3 0.4 – 57.9 - CCND1 7 14.3 0.4 – 57.9 - CDK6 10 30.0 6.7 – 65.2 - EGFR 19 36.8 16.3 – 61.6 7 12.5 4.2 – NE ERBB2 57 40.4 27.6 – 54.2 23 12.4 6.2 – 38.3 PIK3CA 5 40.0 5.3 – 85.3 - *cORR and DOR were not calculated for sample sizes <5.
Clinical • BRCA Biomarker • Metastases
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EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • BRAF (B-raf proto-oncogene) • TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • BRCA2 (Breast cancer 2, early onset) • CCND1 (Cyclin D1) • RAS (Rat Sarcoma Virus) • CDK6 (Cyclin-dependent kinase 6)
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TP53 mutation • HER-2 amplification • PIK3CA mutation • RAS wild-type
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Guardant360® CDx • PGDx elio™ tissue complete assay
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Herceptin (trastuzumab) • Tukysa (tucatinib)
2years
Comprehensive genomic profiling: Insights into diagnostic value and treatment strategy. (ASCO 2022)
NGS can be broadly applied throughout the cancer care continuum, with a new perspective on its potential value diagnostically. In these cases, re-evaluation and subsequent re-classification led to treatment strategy shifts that are more specific to the patient’s tumor type. These findings provide critical real-world evidence that supports the value of broad genomic profiling in complex cancer cases, especially when the genomic findings are inconsistent with the initial diagnosis, or the diagnosis is unclear.
PGDx elio™ tissue complete assay
2years
Prognostic value of post-surgery liquid biopsy cell-free circulating tumor DNA in stage III colon cancer patients - PLCRC-PROVENC3 study (AACR 2022)
Once sequencing data is obtained, multivariate Cox regression analysis will be used to assess the association between post-surgery ctDNA detection and progression-free and overall survival. Ultimately, the results of this study will be used to design an ethically acceptable and cost-effective ctDNA-guided interventional trial in stage III colon cancer patients, in order to improve the risk stratification and reduce futile ACT and its associated side-effects.
Clinical • Liquid biopsy • Circulating tumor DNA
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PGDx elio™ plasma resolve assay • PGDx elio™ tissue complete assay
over2years
PGDx announces an updated Medicare reimbursement rate for the elio™ tissue complete Test (Personal Genome Diagnostics Press Release)
"Personal Genome Diagnostics Inc...today announced an update to the Proprietary Laboratory Analyses (PLA) code for its comprehensive genomic profiling test, PGDx elio™ tissue complete. The Centers for Medicare & Medicaid Services (CMS) finalized a national reimbursement rate of $2,919.60 for the PLA code (0250U) that PGDx obtained for the test...The new Medicare payment rate went into effect on January 1, 2022."
Reimbursement
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PGDx elio™ tissue complete assay
almost3years
Next-Generation Sequencing Concordance Analysis of Comprehensive Solid Tumor Profiling between a Centralized Specialty Laboratory and the Decentralized PGDx Elio Tissue Complete Kitted solution. (PubMed, J Mol Diagn)
Both copy number alterations and gene translocations showed 80-83% PPA, while tumor mutation burden (TMB) and microsatellite status showed a high level of concordance across a range of mutation loads and tumor types. The PGDx eliotissue complete assay is comparable to the FoundationOne test and will allow more laboratories to offer a diagnostic NGS assay in-house, which will ultimately reduce time to result and increase the number of patients receiving molecular genomic profiling and personalized treatment.
Journal • Tumor mutational burden • IO biomarker • Next-generation sequencing
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TMB (Tumor Mutational Burden)
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FoundationOne® CDx • PGDx elio™ tissue complete assay
almost3years
Personal Genome Diagnostics Enters Collaborative Partnership with Clinical Molecular Diagnostics Laboratory of Major University Health System (Personal Genome Diagnostics Press Release)
"Personal Genome Diagnostics Inc...today announced a collaborative partnership with the Duke University Health System (DUHS) Clinical Molecular Diagnostics Laboratory. As part of the collaborative partnership, PGDx’s elio™ tissue complete will be the primary technology platform for the laboratory’s clinical oncology genomic testing initiatives. The laboratory will also collaborate with PGDx on the development of next-generation data integration solutions aimed at optimizing clinical usability of genomic data and insights across the cancer care continuum."
Licensing / partnership
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PGDx elio™ tissue complete assay
over3years
Personal Genome Diagnostics and QIAGEN collaborate to offer integrated genomic testing and interpretation support (Personal Genome Diagnostics Press Release)
"Personal Genome Diagnostics Inc. (PGDx)...announced today that it has entered into a collaboration with QIAGEN to provide comprehensive genomic profiling tests and clinical decision support to molecular labs. Under the non-exclusive agreement, PGDx will be responsible for the distribution of the PGDx elio™ oncology products and kitted solutions. Laboratories that purchase the PGDx elio products will have an option to receive from QIAGEN standardized reporting, driven by professional guidelines for streamlined case review and sign-out. In addition, laboratories will receive access to QIAGEN’s QCI Interpret One for rapid, evidence-based reporting for next-generation sequencing (NGS) oncology tests at scale."
Licensing / partnership
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PGDx elio™ tissue complete assay
over3years
Personal Genome Diagnostics and Almac Diagnostic Services Enter Strategic Collaboration to Enhance Patient Care in Oncology (Businesswire)
"PGDx and Almac Diagnostic Services will focus on providing access to tumor profiling assays for both tissue and plasma samples, specifically, PGDx elio™ tissue complete and PGDx elio™ plasma resolve. This collaboration will combine Almac’s world-class genomics services and expertise in development and delivery of molecular diagnostics with PGDx’s leadership in cancer genomics to accelerate solutions that will deliver precision medicine to more patients."
Licensing / partnership
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PGDx elio™ tissue complete assay
over3years
P1 data • Clinical
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FGFR2 (Fibroblast growth factor receptor 2) • CCDC6 (Coiled-Coil Domain Containing 6) • BICC1 (BicC Family RNA Binding Protein 1)
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FGFR2 mutation • FGFR2 fusion • FGFR2 amplification
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PGDx elio™ tissue complete assay
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tasurgratinib (E7090)
over3years
Genosity announces strategic software collaboration with PGDx to support distribution of PGDx elio™ tissue complete to laboratories (Businesswire)
"Genosity, Inc…announced today that it has entered into a strategic collaboration with Personal Genome Diagnostics Inc. (PGDx)…that recently received market clearance from the U.S. Food and Drug Administration (FDA) for PGDx elio™ tissue complete, a comprehensive diagnostic kit for genomic profiling of cancer…As part of the agreement, Genosity will incorporate the PGDx elio™ tissue complete assay into its software platform and professional consulting services."
Licensing / partnership
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PGDx elio™ tissue complete assay
over3years
Personal Genome Diagnostics Announces Medicare Coverage of PGDx elio tissue complete Assay for Patients with Advanced Cancer (Businesswire)
"Personal Genome Diagnostics Inc...announced...that the CMS Molecular Diagnostics Program (MolDX) has issued a local coverage determination (LCD) for the FDA-cleared PGDx elio™ tissue complete assay. The MolDX coverage determination establishes reimbursement for laboratory facilities across the 28-state MolDx jurisdiction, extending Medicare benefits for this comprehensive genomic test to patients living with advanced cancers."
Reimbursement
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PGDx elio™ tissue complete assay