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TEST:
OncoDEEP

Company:
OncoDNA
Type:
Laboratory Developed Test
Related tests:
2ms
CSFctDNA as a surrogate for tumor tissue DNA in BC pts with CNS metastases: First results from the Brainstorm program (Oncodistinct 006) (AACR 2024)
The use of CSFctDNA as a surrogate for tumor tissue DNA in CNS metastases appears to be a feasible and safe approach. Clinically actionable alterations have been identified in CSFctDNA of pts with BC. Further results will be presented at a later stage.Table 1: Pathogenic molecular alterations in matched tumor, plasma and CSF from pts with detectable CSFctDNA
Clinical
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 positive
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OncoDEEP • OncoFOLLOW
2ms
Comprehensive genomic profiling of solid tumor patients with the OncoDEEP assay for broad analysis in clinical diagnostics (AACR 2024)
All performance metrics passed the validation criteria. In conclusion, the OncoDEEP kit can be used for reliable diagnostic comprehensive profiling of solid tumors, but currently, extensive fusion analysis requires an additional screening method.
Clinical • Tumor mutational burden
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TMB (Tumor Mutational Burden) • MSI (Microsatellite instability) • HRD (Homologous Recombination Deficiency)
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HRD
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OncoDEEP • TruSight Oncology 500 Assay
3ms
Beyond traditional therapies: clinical significance of complex molecular profiling in patients with advanced solid tumours-results from a Turkish multi-centre study. (PubMed)
Our real-world findings highlight the significant impact of complex molecular profiling on the treatment decisions made by oncologists for a substantial portion of patients with advanced solid tumours. Regrettably, no significant advantage was detected in terms of treatment response or disease control rates.
Journal • Metastases
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OncoDEEP
9ms
Analytic validation and implementation of OncoDEEP: A pan-cancer comprehensive genomic profiling NGS assay for assessing homologous recombination deficiency (HRD) (ESMO 2023)
Conclusions Our results demonstrate that OncoDNA's OncoDEEP® kit provides an efficient pan-cancer solution for accurate comprehensive genomic profiling for biomarker-matched therapy selection, including HRD, TMB and MSI. The integrated software suite allows for clinical interpretation and reporting with robust analytical performance.
Tumor mutational burden • Next-generation sequencing • Pan tumor
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ALK (Anaplastic lymphoma kinase) • TMB (Tumor Mutational Burden) • MET (MET proto-oncogene, receptor tyrosine kinase) • MSI (Microsatellite instability) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • HRD (Homologous Recombination Deficiency)
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HRD • MET exon 14 mutation • ALK fusion
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OncoDEEP
over1year
Berkshire and Surrey Pathology Services & ONCODNA announce formation of a national tissue collection centre that will facilitate private NGS testing across the UK (OncoDNA Press Release)
"...this is an important first step in a collaboration that will make it much easier for public and privately practising oncologists to access biopsy tissue and request ONCODEEP for the purpose of routine next generation sequencing."
Licensing / partnership
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OncoDEEP
over1year
OncoDNA announces the operational launch of its OncoDEEP® kit for comprehensive genomic profiling of solid tumors (OncoDNA Press Release)
"ONCODNA...ANNOUNCED THE OFFICIAL LAUNCH OF THE ONCODEEP KIT DURING THE ESMO (EUROPEAN SOCIETY FOR MEDICAL ONCOLOGY) CONGRESS IN PARIS, FRANCE. THE KIT OFFERS A COMPLETE WORKFLOW SOLUTION TO ENABLE LABORATORIES WITH NGS CAPABILITIES TO SUPPORT ONCOLOGISTS IN FINDING THE MOST EFFECTIVE AND PERSONALIZED TREATMENTS FOR THEIR CANCER PATIENTS."
Launch Europe
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OncoDEEP
2years
OncoDNA and Synlab partner to facilitate access to comprehensive biomarker testing for cancer therapy selection in Germany (OncoDNA Press Release)
"OncoDNA...announced today a partnership with Synlab...integrating OncoDEEP in their portfolio, Synlab laboratories in Germany will perform comprehensive testing of solid tumors and deliver decision support for oncologists. The technology transfer is ongoing, with the objective of processing the first patient samples early Q2."
Licensing / partnership
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OncoDEEP
2years
OncoDNA launches OncoDEEP® kit for comprehensive biomarker testing of solid tumors (OncoDNA Press Release)
"OncoDNA...announced today the launch of the OncoDEEP kit. The kit offers a complete workflow solution which enables laboratories with NGS capabilities to perform comprehensive biomarker testing, provide powerful data analysis and support oncologists in the most effective and personalized treatments for their cancer patients. The OncoDEEP kit integrates both reagents and quality control standards for the sequencing of over 600 cancer biomarkers. the offer will come in combination with OncoDNA’s data analysis and clinical interpretation tools for the rapid analysis and reporting of a patient’s tumor molecular profile. OncoDEEP kit is available for early access and will be commercially available by the end of Q2 2022."
Launch
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OncoDEEP
over2years
OncoDNA and Bergonié Institute to test the clinical utility of blood-and tissue-based biomarker tests in oncology (OncoDNA Press Release)
"OncoDNA...and Bergonié Institute...announced a new clinical trial to evaluate the use of comprehensive biomarker testing and liquid biopsy in 700 patients diagnosed with an advanced metastatic cancer. The Appolo study will recruit patients from 6 participating sites across the French Aquitaine region to be offered OncoDEEP® and OncoFOLLOW™ biomarker tests."
New trial
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OncoDEEP • OncoFOLLOW
3years
[VIRTUAL] Analysis of prognostic and predictive factors of response in squamous cell carcinoma using NGS techniques (ELCC 2021)
The samples were analyzed by NGS with the OncoDEEP (OncoDNA) panel covering 313 genes.ResultsOnly one of the cases was not evaluable due to the low cellularity of the tumor block. Of the 12 evaluable cases, molecular alterations were identified in 6 of them, as detailed below: in case number 1 (lung cancer) variant of TP53 cDNA c.595G> T-AA p. G199, in case number 2 (lung cancer) mutation in TP53 cDNA c.488a> G-AAp.Y163C and mutation in FANCA cDNA: c.3263C> T-AA: p.S1088F, in case number 3 (lung cancer) variant de TP53 c.DNA: c.455del-Aap.P152Rfs * 18, alteration in MRE11A cDNA: c.1688C> G-AA: p.S563 * and alteration KEAP1 cDNAc.224dup-Aap.L76Afs * 3, in case number 4 (lung cancer) AKT amplification and alteration in BRCA2 cDNA c.2701del-Aap.A902Lfs * 2, in case number 5 (lung cancer) mutation in PI3KCA E545 K, amplification in MDM2 and mutation in TP53 cDNA c.871AA> T-AA p.K291 *, in case number 6 (bladder cancer) amplification of JAK1 and in case number 7 (head and neck cancer) mutation of PI3KCA E545, mutation of TPMT Y240C and mutation in TPMT A154 T.Conclusions This review presents as its objective the analysis of these molecular alterations and their impact on the prognosis, and therapeutic evolution of patients with the aim of integrating clinical and molecular information in a translational oncology study
BRCA Biomarker • IO biomarker • Next-generation sequencing
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TP53 (Tumor protein P53) • BRCA2 (Breast cancer 2, early onset) • KEAP1 (Kelch Like ECH Associated Protein 1) • MDM2 (E3 ubiquitin protein ligase) • JAK1 (Janus Kinase 1) • FANCA (FA Complementation Group A) • MRE11A (MRE11 homolog, double strand break repair nuclease)
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TP53 mutation • KEAP1 mutation • FANCA mutation • MDM2 mutation • MRE11A mutation
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OncoDEEP
3years
ARID1A genomic alterations driving microsatellite instability through somatic MLH1 methylation with response to immunotherapy in metastatic lung adenocarcinoma: a case report. (PubMed, J Med Case Rep)
"In this particular case, we show that ARID1A gene mutations with sporadic MSI due to somatic MLH1 gene promoter methylation and MLH1 gene mutation could change the prognosis and define the response to immunotherapy in a patient with lung adenocarcinoma. Comprehensive solid and liquid biopsy tests are useful to find out resistance mechanisms to immune checkpoint inhibitors. Our data encourages the development of new therapies against ARID1A mutations and epigenomic methylation when involved in MSI neoplasms."
Journal • Clinical
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EGFR (Epidermal growth factor receptor) • TMB (Tumor Mutational Burden) • MSI (Microsatellite instability) • RET (Ret Proto-Oncogene) • CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • ARID1A (AT-rich interaction domain 1A) • CD8 (cluster of differentiation 8) • MLH1 (MutL homolog 1) • BRCA (Breast cancer early onset)
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PD-L1 expression • EGFR mutation • RET fusion • ARID1A mutation • CDKN2A mutation • MLH1 mutation • BRCA mutation • EGFR R776H • EGFR fusion
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OncoDEEP