FDA-Cleared IVD Comprehensive Genomic Profiling Panel
Available in 6-10 business days
Fast
FDA-Cleared (510k) test
Proven
Clear insights to therapy options
Actionable
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.
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.
What is OncoTarget®500?
20 Translocations
28 Amplifications
505 SNVs and Indels
507 Total genes whole exon
2 Genomic Signatures
cleared for all solid malignant neoplasms
Clinical Values of OncoTarget® 500
Available in 6-10 business days
- Turn-key, automated bioinformatics with machine learning
- Optimized workflow, processing begins immediately
FDA-cleared (510k) test
- 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
- 100% clinical biomarkers covered
- Includes comprehensive list of CDx, NCCN guideline-directed targeted genes
- 500 gene targeted whole-exome sequencin
6-10 Day Turnaround Time
Fast
Achieved by our streamlined lab process and AI-assisted bioinformatics pipeline
Day 4
Next-Generation Sequencing
Day 5
Automated Bioinformatics
Day 6-10
Actionable Report
Hybrid-capture
Library prep
DNA Extraction
Day 3
Day 2
Day 1
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.
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.
First FDA-Cleared IVD Comprehensive
Genomic Profiling Panel
Genomic Profiling Panel
First FDA cleared CE-IVD marked comprehensive kitted solution with bioinformatics
30+ validation studies
Streamlined workflow fast and reliable
Excellent Sensitivity and Specificity
cleared for all solid malignant neoplasms
Excellent results by a large prospective study with leading academic center
proven
Actionable
Genes with FDA-Cleared common malignancies
BIOMARKER:
Keytruda® (pembrolizumab)
- NTRK 1, NTRK 2, NTRK 3
- *MSIHIGH
- ^TMBHIGH
Keytruda® (pembrolizumab)
BIOMARKER:
Mitomycin-C, Gemcitabine (Gemzar), Docetaxel (Taxotere), and Valrubicin (Valstar), Mitomycin (Jelmyto)
- FGFR2, FGFR3 fusions and mutations
Mitomycin-C, Gemcitabine (Gemzar), Docetaxel (Taxotere), and Valrubicin (Valstar), Mitomycin (Jelmyto)
BIOMARKER:
Herceptin® (trastuzumab), Kadcyla® (ado-trastuzumab-emtansine), or Perjeta® (pertuzumab)
BIOMARKER:
Piqray® (alpelisib)
- ERBB2 Amp
Herceptin® (trastuzumab), Kadcyla® (ado-trastuzumab-emtansine), or Perjeta® (pertuzumab)
BIOMARKER:
- PIK3CA mutations
Piqray® (alpelisib)
BIOMARKER:
Pemazyre® (pemigatinib) or TruseltiqTM (infigratinib)
- FGFR2 fusions and select rearrangements
Pemazyre® (pemigatinib) or TruseltiqTM (infigratinib)
BIOMARKER:
Erbitux® (cetuximab)
BIOMARKER:
BRAF Inhibitors approved by FDA
BIOMARKER:
Vectibix® (panitumumab)
- KRAS(wildtype)
Erbitux® (cetuximab)
BIOMARKER:
- BRAF V600E
BRAF Inhibitors approved by FDA
BIOMARKER:
- NRAS
Vectibix® (panitumumab)
BIOMARKER:
Keytruda (Pembrolizumab), Nivolumab, Opdivo (Nivolumab), Pembrolizumab
- *MSIHIGH
Keytruda (Pembrolizumab), Nivolumab, Opdivo (Nivolumab), Pembrolizumab
BIOMARKER:
Avapritinib, Ayvakit (Avapritinib), Gleevec (Imatinib Mesylate), Imatinib Mesylate, Qinlock (Ripretinib), Regorafenib, Ripretinib, Stivarga (Regorafenib), Sunitinib Malate, Sutent (Sunitinib Malate)
- KIT
- KIT
Avapritinib, Ayvakit (Avapritinib), Gleevec (Imatinib Mesylate), Imatinib Mesylate, Qinlock (Ripretinib), Regorafenib, Ripretinib, Stivarga (Regorafenib), Sunitinib Malate, Sutent (Sunitinib Malate)
BIOMARKER:
Tafinlar® (dabrafenib) or Zelboraf® (vemurafenib)
BIOMARKER:
Mekinist® (trametinib) or Cotellic® (cobimetinib) in combination with Zelboraf® (vemurafenib)
- BRAF V600E
Tafinlar® (dabrafenib) or Zelboraf® (vemurafenib)
BIOMARKER:
- BRAF V600E/K
- BRAF V600
Mekinist® (trametinib) or Cotellic® (cobimetinib) in combination with Zelboraf® (vemurafenib)
BIOMARKER:
Selumetinib (KOSELUGO, AstraZeneca)
- NF1
Selumetinib (KOSELUGO, AstraZeneca)
BIOMARKER:
Lynparza® (olaparib) or Rubraca® (rucaparib)
- BRCA1, BRCA2
Lynparza® (olaparib) or Rubraca® (rucaparib)
BIOMARKER:
Lynparza® (olaparib)
- ATM, BARD1, BRIP1, CDK12, CHEK1, CHEK2, FANCL, PALB2, RAD51B, RAD51C, RAD51D, RAD54L
- BRCA1, BRCA2
Lynparza® (olaparib)
BIOMARKER:
- 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)
BIOMARKER:
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
- BRAF v600E (anaplastic)
- RET (Medullary)
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
Additional testing available
- Three different tests to determine cancer risk – PROSTATENOW™ – Germline test for prostate cancer, BRCANOW® – Hereditary test for breast and ovarian cancer -LYNCHNOW® – Screening to detect lynch syndrome.
- GoPath® LabsTesting for a diagnosis, therapy and monitoring of certain blood disorders including leukemia and lymphoma.
- OncoTracking™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.
- OncoTarget®Delivering the broadest, FDA-cleared Comprehensive Genomic Profiling for solid tumors.