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1year
The genomic landscape of TERT alterations in bladder cancer. (ASCO-GU 2023)
The Oncomap ExTra assay allowed identification of both commonly observed and rare TERT promoter mutations, including a fusion, in 78.9% of bladder cancer patients. Such assays are useful to identify both TERT alterations prognostic for progression and patients eligible for clinical trials evaluating TERT-directed therapies. In addition, TERT mutations may be associated with FGFR3 mutations and high TMB, which have matched therapies, though these associations need to be validated in an independent cohort.
Tumor mutational burden • BRCA Biomarker
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TMB (Tumor Mutational Burden) • BRCA2 (Breast cancer 2, early onset) • MSI (Microsatellite instability) • FGFR3 (Fibroblast growth factor receptor 3) • TERT (Telomerase Reverse Transcriptase)
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TMB-H • FGFR3 mutation • FGFR3 fusion • TERT mutation • TERT promoter mutation
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Oncomap™ ExTra test
1year
Erythroblast transformation-specific transcription factor fusions in prostate cancer. (ASCO-GU 2023)
In addition to TMPRSS2:ERG, the Oncomap ExTra assay identified several low frequency ETS fusions, all of which could be used to assist patients and physicians to select appropriate treatments. The identification of ETS fusions appears to be limited when using only DNA sequencing. Oncomap ExTra RNA analysis identified 66 additional fusions, representing almost 30% of those present, not identified by whole-exome DNA sequencing, suggesting RNA plus DNA assays detect fusions more reliably than DNA-only assays.
ERG (ETS Transcription Factor ERG) • ETV1 (ETS Variant Transcription Factor 1) • SLC45A3 (Solute Carrier Family 45 Member 3)
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TMPRSS2-ERG fusion
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Oncomap™ ExTra test
1year
Molecular Characterization of Well Differentiated Squamous Cell Carcinoma with Verrucoid Features, So-Called Barnaculate Carcinoma: Identification of Mutations in Promoter Region of Telomerase Reverse Transcriptase (TERT) And HRAS gene (USCAP 2023)
Although the findings are preliminary due to limited case numbers, the identification of these mutations may be a useful adjunct to the diagnosis of barnaculate carcinoma. Additional studies including more cases will be needed to validate the study results and identify tumorigenic roles and clinical significance of these mutations.
HRAS (Harvey rat sarcoma viral oncogene homolog) • TERT (Telomerase Reverse Transcriptase)
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TERT mutation • TERT promoter mutation • TERT 124C>T
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Oncomap™ ExTra test
over1year
Clinical • Minimal residual disease • Circulating tumor DNA
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Oncomap™ ExTra test • Oncotype DX® Colon Recurrence Score test
over1year
ONCX-NAV-G201: A phase 2 basket study of navicixizumab monotherapy or in combination with chemotherapy in patients with select advanced solid tumors—Colorectal Cancer Cohort (trial in progress). (ASCO-GI 2023)
Up to 30 patients will be enrolled to each CRC cohort from approximately 8 sites in the US and will receive 3 mg/kg navicixizumab alone (Cohort A1) or in combination with irinotecan (180 mg/m2 on Days 1 and 15 of a 28-day cycle, Cohort A2). Secondary efficacy endpoints include overall survival, time to response, disease control rate, duration of response, and the relationship between antitumor activity of navicixizumab and Xerna TME Panel biomarker subtypes. Clinical trial information: NCT05453825.
Combination therapy • P2 data • Clinical • Pan tumor • Metastases
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Oncomap™ ExTra test • Xerna TME™ Panel
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irinotecan • navicixizumab (OMP-305B83)
over1year
The Wnt signaling pathway in gastrointestinal cancers. (ASCO-GI 2023)
Wnt signaling is activated in about half of all GI cancers, and APC alterations are the most frequently observed. Whole transcriptome profiling allowed us to identify RSPO2/3 fusions, which also contribute to activation of the Wnt pathway. Wnt activation appears to be a particularly important in CRC, with 81.1% of CRC having a Wnt pathway alteration.
RNF43 (Ring Finger Protein 43) • RSPO2 (R-Spondin 2)
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Oncomap™ ExTra test
over1year
Prevalence and genomic landscape of BRAF alterations across gastrointestinal cancers. (ASCO-GI 2023)
The combination of dabrafenib plus trametinib was recently FDA-approved for use in these BRAF V600E altered unresectable or metastatic cancers. Analysis of whole-exome and whole transcriptome sequencing data found actionable BRAF mutations in 4.4% of GI cancer patients, 37.6% of whom had BRAF mutations not at V600. Several biomarkers were significantly associated with BRAF alterations. Assays that are limited to DNA sequencing, or to targeted gene panels, may not detect mutations and fusions that could aid in therapy selection and prognosis.
Tumor mutational burden • MSi-H Biomarker
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BRAF (B-raf proto-oncogene) • TMB (Tumor Mutational Burden) • MSI (Microsatellite instability)
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BRAF V600E • TMB-H • MSI-H/dMMR • BRAF fusion • BRAF K601E • BRAF K601
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Oncomap™ ExTra test
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Mekinist (trametinib) • Tafinlar (dabrafenib)
over1year
Exact Sciences highlights the impact of precision oncology portfolio on breast cancer treatment with 10 new data presentations at SABCS 2022 (Exact Sciences Press Release)
"Exact Sciences Corp...announced that new data presentations supporting the clinical value of its Precision Oncology portfolio will be shared in ten abstracts and three presentations at the 2022 San Antonio Breast Cancer Symposium (SABCS). The data presented highlight the Oncotype DX Breast Recurrence Score test, Oncomap ExTra test, a new investigational test to predict radiation therapy benefit, and an initial look at Exact Sciences' tumor-naive minimal residual disease (MRD) approach."
Clinical data
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Oncomap™ ExTra test • Oncotype DX Breast Recurrence Score®Test
over1year
ONCX-NAV-G201: A phase 2, basket study of navicixizumab monotherapy or in combination with chemotherapy in patients with select advanced solid tumors: Triple-negative breast cancer cohort (trial in progress) (SABCS 2022)
Eligible TNBC patients will have locally advanced or metastatic disease and have received at least 2 and no more than 4 prior lines of standard therapy for metastatic disease, including immunotherapy (for PD-L1 positive TNBC patients), and sacituzumab govitecan...Up to 30 patients will be enrolled to each TNBC cohort from approximately 8 sites in the US and will receive 3 mg/kg navicixizumab alone (Cohort C1) or in combination with paclitaxel (80 mg/m2 on Days 1, 8, and 15 of a 28-day cycle) (Cohort C2)...Cohort continuation and future evaluation decisions will be guided by the boundaries identified by a sequential monitoring procedure. Secondary efficacy endpoints include overall survival, time to response, disease control rate, duration of response, and the relationship between antitumor activity of navicixizumab and Xerna TME Panel™ biomarker subtypes.
Combination therapy • P2 data • Clinical • PD(L)-1 Biomarker • IO biomarker • Pan tumor
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HER-2 (Human epidermal growth factor receptor 2)
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PD-L1 expression • HER-2 negative
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Oncomap™ ExTra test • Xerna TME™ Panel
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paclitaxel • Trodelvy (sacituzumab govitecan-hziy) • navicixizumab (OMP-305B83)
over1year
ESR1-alterations in HR+HER2- breast cancer patients (SABCS 2022)
Table 1. Biomarkers that showed the highest association with ESR1 and other notable breast cancer biomarkers.
Clinical • Tumor mutational burden • MSi-H Biomarker
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HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • TMB (Tumor Mutational Burden) • MSI (Microsatellite instability) • AKT1 (V-akt murine thymoma viral oncogene homolog 1) • CCDC170(Coiled-Coil Domain Containing 170)
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MSI-H/dMMR • HER-2 negative • ER Y537S
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Oncomap™ ExTra test
almost2years
Exact Sciences showcases breadth of early detection and treatment guidance portfolio with multiple data presentations at ASCO 2022 (Exact Sciences Press Release)
"Exact Sciences Corp...announced new data supporting its cancer tests and treatment guidance tools will be showcased in nine poster presentations and five e-abstracts at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, being held June 3-7 in Chicago, Illinois...The analyses support use of Oncomap™ and Oncomap™ ExTra, comprehensive genomic profiling tests formerly known as the Oncotype Map™ Pan-Cancer Tissue and GEM ExTra® tests, respectively, to inform targeted therapy selection and clinical trial options for patients with advanced solid tumors."
Clinical data
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Oncomap™ ExTra test • Oncotype MAP™ Pan-Cancer Tissue Test
2years
Comprehensive genomic profiling to identify biomarkers predictive of response to immunotherapy (AACR 2022)
Our study found I-O sensitive BMs in common and in rare aggressive cancers. The GEM ExTra assay can stratify cancer patients for likely responsiveness to immunotherapy. >
Tumor mutational burden • PD(L)-1 Biomarker • MSi-H Biomarker • IO biomarker
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PD-L1 (Programmed death ligand 1) • KRAS (KRAS proto-oncogene GTPase) • TMB (Tumor Mutational Burden) • MSI (Microsatellite instability) • STK11 (Serine/threonine kinase 11) • JAK2 (Janus kinase 2) • POLE (DNA Polymerase Epsilon) • PBRM1 (Polybromo 1) • MLH1 (MutL homolog 1) • MSH2 (MutS Homolog 2) • B2M (Beta-2-microglobulin) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4) • JAK1 (Janus Kinase 1) • POLD1 (DNA Polymerase Delta 1) • IDO1 (Indoleamine 2,3-dioxygenase 1) • ARID2 (AT-Rich Interaction Domain 2) • PMS1 (PMS1 protein homolog 1)
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KRAS mutation • TMB-H • MSI-H/dMMR • STK11 mutation • PBRM1 mutation • MSH2 mutation • POLD1 mutation • PMS1 mutation
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Oncomap™ ExTra test
2years
Exact Sciences and OncXerna Announce Licensing Agreement to Help Predict Immunotherapy Response for More Patients (Exact Sciences Press Release)
"Exact Sciences...and OncXerna Therapeutics...announced today they have entered an exclusive license agreement to bring OncXerna's Xerna TME Panel lab services to more U.S. patients. The Xerna TME (tumor microenvironment) Panel is an innovative gene expression score that helps identify patients likely to respond to anti-angiogenic and immunotherapies. The agreement allows Exact Sciences to provide more critical answers to cancer patients and physicians facing difficult therapy selection decisions supporting biopharma partners in patient selection for their therapeutic programs."
Licensing / partnership
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Oncomap™ ExTra test
2years
Characterization of aberrant alternative splicing landscape in patients with renal cell carcinoma (RCC). (ASCO-GU 2022)
In depth examination of this large cohort suggests that IR resulting from AS events occur frequently within RCC. Further efforts to investigate the association of AS events and clinical outcomes are underway.
Clinical
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Oncomap™ ExTra test
almost3years
Analytic validation and clinical utilization of the comprehensive genomic profiling test, GEM ExTra. (PubMed, Oncotarget)
GEM ExTra demonstrated analytic specificity (PPV) of > 99.9% and analytic sensitivity of 98.8%. Application of GEM ExTra to 1,435 patient samples revealed clinically actionable alterations in 83.9% of reports, including 31 (2.5%) where therapeutic recommendations were based on RNA fusion findings only.
Journal • Clinical • Tumor mutational burden
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EGFR (Epidermal growth factor receptor) • TMB (Tumor Mutational Burden) • MET (MET proto-oncogene, receptor tyrosine kinase) • MSI (Microsatellite instability)
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MET exon 14 mutation • AR splice variant 7
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Oncomap™ ExTra test
3years
[VIRTUAL] Comparison of whole exome sequencing and targeted sequencing in patients with advanced bladder cancer (AACR 2021)
Although the majority of GAs identified were concordant, each platform exclusively identified GAs with varying clinical significance. SOX4 and E2F3 mutation, shown to correlate with invasive potential in bladder cancer, were detected exclusively on WES. In contrast, RBM and CHEK2 (of known significance in melanoma and breast cancer) were found exclusively on TS.
Late-breaking abstract • Clinical
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HER-2 (Human epidermal growth factor receptor 2) • TP53 (Tumor protein P53) • KMT2D (Lysine Methyltransferase 2D) • CHEK2 (Checkpoint kinase 2) • MLL2 (Myeloid/lymphoid or mixed-lineage leukemia 2) • E2F3 (E2F transcription factor 3) • SOX4 (SRY-Box Transcription Factor 4)
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CHEK2 mutation
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FoundationOne® CDx • Oncomap™ ExTra test
3years
[VIRTUAL] Radiomic features of renal cell carcinoma primary and metastatic sites as predictors of TERT and BAP1 mutations. (ASCO-GU 2021)
By identifying a correlation between radiomic features of TERT mutation in primary tumors and BAP1 mutation in metastatic sites, our work may ultimately yield a non-invasive method of discerning mutational status in patents with mRCC. Efforts are ongoing to validate our findings within The Cancer Imaging Archive.
TERT (Telomerase Reverse Transcriptase) • BAP1 (BRCA1 Associated Protein 1)
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BAP1 mutation
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Oncomap™ ExTra test
3years
[VIRTUAL] Illustration of temporal evolution in patients with metastatic renal cell carcinoma (mRCC) using both circulating tumor DNA (ctDNA) and tissue-based genomic data. (ASCO-GU 2021)
Our study confirms that ctDNA and tissue-based genomic profiling continue to provide consistently high levels of agreement. Notably, the percentage of samples with ≥1 ctDNA alteration detected was significantly lower in both cohorts compared to previous studies in RCC. More shared alterations were found on ctDNA when both ctDNA and tissue-based assessment were obtained at closer intervals.
Clinical
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Guardant360® CDx • Oncomap™ ExTra test
3years
[VIRTUAL] Illustration of temporal evolution in patients with metastatic renal cell carcinoma (mRCC) using both circulating tumor DNA (ctDNA) and tissue-based genomic data. (ASCO-GU 2021)
Our study confirms that ctDNA and tissue-based genomic profiling continue to provide consistently high levels of agreement. Notably, the percentage of samples with ≥1 ctDNA alteration detected was significantly lower in both cohorts compared to previous studies in RCC. More shared alterations were found on ctDNA when both ctDNA and tissue-based assessment were obtained at closer intervals.
Clinical
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Guardant360® CDx • Oncomap™ ExTra test