OncoTarget®500
Comprehensive Genomic Profiling Panel
Fast
Available in 7-10 business days
Proven
505 Total Genes Whole Exon
Actionable
Clear insights to therapy options
What is OncoTarget®500?
OncoTarget® 500 integrates the robust bioinformatics of PGDx Elio Tissue Complete and provides physicians and researchers with medically actionable analyses on hundreds of cancer-related genes to help determine the specific genomic profile of an individual tumor.
Based on the unique genomic profile of each patient's cancer, our test provides physicians with clinically actionable information to consider appropriate therapies for each patient and identify resistance to those therapies.
PD-L1 immunohistochemistry (IHC) testing is performed with a wide range of monoclonal antibodies. Results for microsatellite instability and tumor mutational burden are used to inform immunotherapy decisions, as well as many other actionable mutations.
FFPE samples are stained with H&E and reviewed by board-certified pathologists for tumor areas. A macro-dissection is performed to enrich the tumor content by no less than 20%.
Patients with qualifying Medicare or Medicare Advantage can receive OncoTarget® 500 across all solid tumors via Palmetto LCD.
PD-L1 immunohistochemistry (IHC) testing is performed with a wide range of monoclonal antibodies. Results for microsatellite instability and tumor mutational burden are used to inform immunotherapy decisions, as well as many other actionable mutations.
FFPE samples are stained with H&E and reviewed by board-certified pathologists for tumor areas. A macro-dissection is performed to enrich the tumor content by no less than 20%.
Patients with qualifying Medicare or Medicare Advantage can receive OncoTarget® 500 across all solid tumors via Palmetto LCD.
- 505 Total Genes Whole Exon
- 505 SNVs And Indels
- 28 Amplifications
- 20 Translocations
- 2 Genomic Signatures
- Cleared For All Solid Malignant Neoplasms
Clinical Values of OncoTarget® 500
- Fast. Available in 7-10
business days.- Turn-key, automated bioinformatics with machine learning
- Optimized workflow, processing begins immediately
1 - Proven. 505-genes tested.
- Assay developed from 30+ validation studies
- For all solid tumors
- Clinical pass rate of 92.9%
- Guidance for immune therapy
2 - Actionable. Clear insights
to therapy options.- 100% clinical biomarkers covered
- Includes a comprehensive list of CDx, NCCN guideline-directed targeted genes
- 505 gene targeted whole-exome sequencing
3
7-10 Day Turnaround Time
Achieved by our streamlined lab process and AI-assisted
bioinformatics pipeline
bioinformatics pipeline
1
Step 1
DNA Extraction
2
Step 2
Library prep
3
Step 3
Hybrid-capture
4
Step 4
Next-Generation Sequencing
5
Step 5
Automated Bioinformatics
6
Step 6
Pathologist review & sign out
7
Step 7
Actionable report delivered
First FDA-Cleared IVD Comprehensive
Genomic Profiling Panel
Genomic Profiling Panel
OncoTarget 500® is tissue-based, clinically, and analytically validated for all solid malignant neoplasms.
- First FDA Cleared CE-IVD Marked Comprehensive Kitted Solution with Bioinformatics
- Streamlined Workflow, Fast and Reliable
- Excellent Results By A Large Prospective Study with Leading Academic Center
- 30+ Validation Studies
- Excellent Sensitivity and Specificity
- Cleared For All Solid Malignant Neoplasms
Genes with FDA-Cleared Common Malignancies
All solid
Biomarkers
NTRK 1, NTRK 2, NTRK 3
*MSIHIGH
^TMBHIGH
FDA-APPROVED THERAPY:
Keytruda® (pembrolizumab)
Keytruda® (pembrolizumab)
Bladder
Biomarker
FGFR2, FGFR3 fusions and mutations
FDA-APPROVED THERAPY:
Mitomycin-C, Gemcitabine (Gemzar), Docetaxel (Taxotere), and Valrubicin (Valstar), Mitomycin (Jelmyto)
Mitomycin-C, Gemcitabine (Gemzar), Docetaxel (Taxotere), and Valrubicin (Valstar), Mitomycin (Jelmyto)
Breast
Biomarkers
ERBB2 Amp
PIK3CA mutations
PIK3CA mutations
FDA-APPROVED THERAPY:
For ERBB2 Amp: Herceptin® (trastuzumab), Kadcyla® (ado-trastuzumab-emtansine), or Perjeta® (pertuzumab)
For PIK3CA mutations: Piqray® (alpelisib)
For ERBB2 Amp: Herceptin® (trastuzumab), Kadcyla® (ado-trastuzumab-emtansine), or Perjeta® (pertuzumab)
For PIK3CA mutations: Piqray® (alpelisib)
Cholangiocarcinoma
Biomarker
FGFR2 fusions and select rearrangements
FDA-APPROVED THERAPY:
Pemazyre® (pemigatinib) or TruseltiqTM (infigratinib)
Pemazyre® (pemigatinib) or TruseltiqTM (infigratinib)
Colorectal
Biomarkers
KRAS(wildtype)
BRAF V600E
NRAS
FDA-APPROVED THERAPY:
For KRAS: Erbitux® (cetuximab)
For BRAF: BRAF Inhibitors approved by FDA
For NRAS: Vectibix® (panitumumab)
For KRAS: Erbitux® (cetuximab)
For BRAF: BRAF Inhibitors approved by FDA
For NRAS: Vectibix® (panitumumab)
Esophagogastric
Biomarker
*MSIHIGH
FDA-APPROVED THERAPY:
Keytruda (Pembrolizumab), Nivolumab, Opdivo (Nivolumab), Pembrolizumab
Keytruda (Pembrolizumab), Nivolumab, Opdivo (Nivolumab), Pembrolizumab
Gastrointestinal stromal tumor "Gist"
Biomarkers
KIT
KIT
FDA-APPROVED THERAPY:
Avapritinib, Ayvakit (Avapritinib), Gleevec (Imatinib Mesylate), Imatinib Mesylate, Qinlock (Ripretinib), Regorafenib, Ripretinib, Stivarga (Regorafenib), Sunitinib Malate, Sutent (Sunitinib Malate)
Avapritinib, Ayvakit (Avapritinib), Gleevec (Imatinib Mesylate), Imatinib Mesylate, Qinlock (Ripretinib), Regorafenib, Ripretinib, Stivarga (Regorafenib), Sunitinib Malate, Sutent (Sunitinib Malate)
Melanoma
Biomarkers
BRAF V600E
BRAF V600E/K
BRAF V600
FDA-APPROVED THERAPY:
For BRAF V600E: Tafinlar® (dabrafenib) or Zelboraf® (vemurafenib)
For BRAF V600E/K and BRAF V600: Mekinist® (trametinib) or Cotellic® (cobimetinib) in combination with Zelboraf® (vemurafenib)
For BRAF V600E: Tafinlar® (dabrafenib) or Zelboraf® (vemurafenib)
For BRAF V600E/K and BRAF V600: Mekinist® (trametinib) or Cotellic® (cobimetinib) in combination with Zelboraf® (vemurafenib)
Neurofibroma
Biomarker
NF1
FDA-APPROVED THERAPY:
Selumetinib (KOSELUGO, AstraZeneca)
Selumetinib (KOSELUGO, AstraZeneca)
Ovarian
Biomarkers
BRCA1, BRCA2
FDA-APPROVED THERAPY:
Lynparza® (olaparib) or Rubraca® (rucaparib)
Prostate
Biomarkers
ATM, BARD1, BRIP1, CDK12, CHEK1, CHEK2, FANCL, PALB2, RAD51B, RAD51C, RAD51D, RAD54L
BRCA1, BRCA2
FDA-APPROVED THERAPY:
Lynparza® (olaparib)
Lynparza® (olaparib)
Sarcoma
Biomarkers
SMARCB1 (epithelioid)
COL1A1-PDGFB fusion (dermatofibrosarcoma protuberans)
FDA-APPROVED THERAPY:
Cosmegen (Dactinomycin), Dactinomycin, Doxorubicin Hydrochloride, Eribulin Mesylate, Gleevec (Imatinib Mesylate), Halaven (Eribulin Mesylate), Imatinib Mesylate, Pazopanib Hydrochloride, Tazemetostat Hydrobromide, Tazverik (Tazemetostat Hydrobromide), Trabectedin, Votrient (Pazopanib Hydrochloride), Yondelis (Trabectedin)
Thyroid
Biomarkers
BRAF v600E (anaplastic)
RET (Medullary)
FDA-APPROVED THERAPY:
Cabozantinib-S-Malate, Caprelsa (Vandetanib), Cometriq (Cabozantinib-S-Malate), Dabrafenib Mesylate, Doxorubicin Hydrochloride, Gavreto (Pralsetinib), Lenvatinib Mesylate, Lenvima (Lenvatinib Mesylate), Mekinist (Trametinib Dimethyl Sulfoxide), Nexavar (Sorafenib Tosylate), Pralsetinib, Retevmo (Selpercatinib), Selpercatinib, Sorafenib Tosylate, Tafinlar (Dabrafenib Mesylate), Trametinib Dimethyl Sulfoxide, Vandetanib
Cabozantinib-S-Malate, Caprelsa (Vandetanib), Cometriq (Cabozantinib-S-Malate), Dabrafenib Mesylate, Doxorubicin Hydrochloride, Gavreto (Pralsetinib), Lenvatinib Mesylate, Lenvima (Lenvatinib Mesylate), Mekinist (Trametinib Dimethyl Sulfoxide), Nexavar (Sorafenib Tosylate), Pralsetinib, Retevmo (Selpercatinib), Selpercatinib, Sorafenib Tosylate, Tafinlar (Dabrafenib Mesylate), Trametinib Dimethyl Sulfoxide, Vandetanib
Sample reports
- Sample Report of Breast Cancer
- Sample Report of Colon Cancer
- Sample Report of Lung Cancer
- Sample Report of Prostate Cancer
