OncoTarget® 500
First FDA-Cleared IVD Comprehensive Genomic Profiling Panel
Fast
Available in 6-7 business days
Proven
FDA-Cleared (510k) test
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 will be performed with a wide range of monoclonal antibodies. Results for microsatellite instability and tumor mutational burden will help inform immunotherapy decisions, as well as many other actionable mutations.

FFPE samples will be stained with H&E and reviewed by board-certified pathologists for tumor areas. A macro-dissection will be 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.
507 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
Available in 6-10 business days
Fast
  • Turn-key, automated bioinformatics with machine learning
  • Optimized workflow, processing begins immediately
FDA-cleared (510k) test
Proven
  • Assay developed from 30+ validation studies
  • FDA cleared for all solid tumors
  • Clinical pass rate of 92.9%
  • Guidance for immune therapy
Clear insights to therapy options
Actionable
  • 100% clinical biomarkers covered
  • Includes comprehensive list of CDx, NCCN guideline-directed targeted genes
  • 500 gene targeted whole-exome sequencin
6-7 Day Turnaround Time
Achieved by our streamlined lab process and AI-assisted bioinformatics pipeline
Library prep
Hybrid-capture
Next-Generation Sequencing
Automated Bioinformatics
Actionable Report
DNA Extraction
Day 1
Day 2
Day 3
Day 4
Day 5
Day 6-7
First FDA-Cleared IVD Comprehensive
Genomic Profiling Panel
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
OncoTarget 500 is tissue-based, clinically, and analytically validated for all solid malignant neoplasms.

This panel provides tumor mutation profiling information on somatic alterations (SNVs, small insertions and deletions, one amplification and four translocations), microsatellite instability (MSI) and tumor mutation burden (TMB) for use by qualified healthcare professionals in accordance with professional guidelines in oncology for previously diagnosed cancer patients.
Genes with FDA-Cleared common malignancies
All solid
BIOMARKER:
  • NTRK 1, NTRK 2, NTRK 3
  • *MSIHIGH
  • ^TMBHIGH
FDA-APPROVED THERAPY:
  • Keytruda® (pembrolizumab)
Bladder
BIOMARKER:
  • FGFR2, FGFR3 fusions and mutations
FDA-APPROVED THERAPY:
  • Mitomycin-CGemcitabine (Gemzar), Docetaxel (Taxotere), and Valrubicin (Valstar), Mitomycin (Jelmyto)
Breast
BIOMARKER:
  • ERBB2 Amp
FDA-APPROVED THERAPY:
Herceptin® (trastuzumab), Kadcyla® (ado-trastuzumab-emtansine), or Perjeta® (pertuzumab)

BIOMARKER:
  • PIK3CA mutations
FDA-APPROVED THERAPY:
  • Piqray® (alpelisib)
Cholangiocarcinoma
BIOMARKER:
  • FGFR2 fusions and select rearrangements
FDA-APPROVED THERAPY:
  • Pemazyre® (pemigatinib) or TruseltiqTM (infigratinib)
Colorectal
BIOMARKER:
  • KRAS(wildtype)
FDA-APPROVED THERAPY:
Erbitux® (cetuximab)

BIOMARKER:
  • BRAF V600E
FDA-APPROVED THERAPY:
BRAF Inhibitors approved by FDA

BIOMARKER:
  • NRAS
FDA-APPROVED THERAPY:
Vectibix® (panitumumab)
Esophagogastric
BIOMARKER:
  • *MSIHIGH
FDA-APPROVED THERAPY:
Keytruda (Pembrolizumab), Nivolumab, Opdivo (Nivolumab), Pembrolizumab
Gastrointestinal stromal tumor "Gist"
BIOMARKER:
  • KIT
  • KIT
FDA-APPROVED THERAPY:
AvapritinibAyvakit (Avapritinib), Gleevec (Imatinib Mesylate), Imatinib Mesylate, Qinlock (Ripretinib), RegorafenibRipretinibStivarga (Regorafenib), Sunitinib MalateSutent (Sunitinib Malate)
Melanoma
BIOMARKER:
  • BRAF V600E
FDA-APPROVED THERAPY:
Tafinlar® (dabrafenib) or Zelboraf® (vemurafenib)

BIOMARKER:
  • BRAF V600E/K
  • BRAF V600
FDA-APPROVED THERAPY:
Mekinist® (trametinib) or Cotellic® (cobimetinib) in combination with Zelboraf® (vemurafenib)
Neurofibroma
BIOMARKER:
  • NF1
FDA-APPROVED THERAPY:
Selumetinib (KOSELUGO, AstraZeneca)
Ovarian


BIOMARKER:

  • BRCA1, BRCA2

FDA-APPROVED THERAPY:

Lynparza® (olaparib) or Rubraca® (rucaparib)

Prostate
BIOMARKER:
  • ATM, BARD1, BRIP1, CDK12, CHEK1, CHEK2, FANCL, PALB2, RAD51B, RAD51C, RAD51D, RAD54L
  • BRCA1, BRCA2
FDA-APPROVED THERAPY:
Lynparza® (olaparib)
Sarcoma
BIOMARKER:
  • SMARCB1 (epithelioid)
  • COL1A1-PDGFB fusion (dermatofibrosarcoma protuberans)

FDA-APPROVED THERAPY:

Cosmegen (Dactinomycin), DactinomycinDoxorubicin HydrochlorideEribulin MesylateGleevec (Imatinib Mesylate), Halaven (Eribulin Mesylate), Imatinib MesylatePazopanib HydrochlorideTazemetostat HydrobromideTazverik (Tazemetostat Hydrobromide), TrabectedinVotrient (Pazopanib Hydrochloride), Yondelis (Trabectedin)

Thyroid
BIOMARKER:
  • BRAF v600E (anaplastic)
  • RET (Medullary)
FDA-APPROVED THERAPY:
Cabozantinib-S-MalateCaprelsa (Vandetanib), Cometriq (Cabozantinib-S-Malate), Dabrafenib MesylateDoxorubicin HydrochlorideGavreto (Pralsetinib), Lenvatinib MesylateLenvima (Lenvatinib Mesylate), Mekinist (Trametinib Dimethyl Sulfoxide), Nexavar (Sorafenib Tosylate), PralsetinibRetevmo (Selpercatinib), SelpercatinibSorafenib TosylateTafinlar (Dabrafenib Mesylate), Trametinib Dimethyl SulfoxideVandetanib
OncoTarget®500 Sample report of Colon cancer
View report
OncoTarget®500 Sample report of Lung cancer
View report
Sample reports
OncoTarget®500 Sample report of Breast cancer
View report
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Whether a patient is in remission or is currently undergoing treatment, the sooner cancer recurrence or metastasis is found, the sooner the patient can receive appropriate therapy and treatment.
OncoTracking™
Delivering the broadest, FDA-cleared Comprehensive Genomic Profiling for solid tumors.
OncoTarget®
Begin your journey- our team is ready to get you started.
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Email: contact@gopathlabs.com

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