GENE-TECH LABORATORIES

Name Oncotype DX
Description Oncotype DX® is a diagnostic assay that quantifies the likelihood of breast cancer recurrence in women with newly diagnosed, early stage breast cancer. In addition to predicting distant disease recurrence, Oncotype DX® also assesses the benefit from certain types of chemotherapy. Test analyses the expression of a panel of 21 genes and the results are provided as a Recurrence Score™ (0-100). The gene panel was selected and the Recurrence Score calculation was derived through extensive laboratory testing and multiple independent clinical development studies.
Specimen The assay-performed using formalin-fixed, paraffin-embedded tumor tissue
TAT 10 Working Days
Regulatory Status CLIA- Certified (Clinical Laboratory Improvement Amendments of 1988) CAP-accredited reference laboratory
Business Partner Genomic Health, Inc.-Newbrigde Pharmaceuticals
Name Guardant360
Description Guardant360® assay is a liquid biopsy that provides fast, accurate and comprehensive genomic results from a simple blood draw. Test results are available in approximately seven days upon receipt in the US laboratory. The test is done using circulating tumor DNA (ctDNA), which is produced when tumors shed small pieces or their genetic material into the bloodstream. Guardant360® assay examines a panel of 74 genes (specifications) to identify any alterations in the tumor DNA. Since its launch in 2014, Guardant360® assay has been ordered by more than 6,000 oncologists over 100,000 times for patients with advanced cancer to help select treatment.
Use and indication • Advanced stage – solid tumor -cancer patient with a solid tumor, whose tissue biopsy is insufficient for genetic testing. • Advanced stage cancer patient who wants to identify targeted therapy options while avoiding an invasive repeated tissue biopsy.
TAT 7 Working Days
FDA Approval First FDA approved Liquid biopsy based NGS test
Specimen 20 ml Blood
Business Partner Guardant Health-Newbridge Pharmaceuticals

OncoDNA develops and improves Theranostic solutions to offer the best options for treating cancer patients. They launched their first solution in 2014, with the innovative approach of combining Next-Generation Sequencing (NGS) with Immunohistochemistry (IHC).This gives a comprehensive view of the tumor profile, at both DNA and protein levels and opens more therapeutic options for the patient.In 2016, we included liquid biopsy analyses in our solution portfolio, either in combination with solid biopsy analysis or as a stand-alone analysis for diagnostic or monitoring purposes.

 3 Theranostic solutions to offer the best options for treating cancer patients

Name OncoDEEP
Description OncoDEEP offers the most complete and comprehensive combination of DNA/RNA/proteins tests. OncoDEEP analyses solid biopsies by combining next-generation sequencing (313 genes), IHCs to study protein expression and additional tests. This complete tumor profiling allows to predict patient response to approved or experimental hormonal therapies, targeted drugs, immunotherapies and chemotherapies. The NGS panel is accurately designed according to oncologists’ needs in their current practice. Importantly, it includes an accurate determination of MSI, TMB and LOH. The NGS panel is regularly updated based on new findings reported in the literature in order to provide patients with the most cost-effective solution.
Recommended for All solid tumors (stage III or IV) in adults Glioblastoma in children
Gene Panel 313 genes
Specimen 1 block or 25 slides (5 μm on Super Frost Plus)
TAT 10 Working Days
Name OncoSTRAT&GO
Description This solution is an integrated approach that combines the analyses of a solid biopsy (by next-generation sequencing (313 genes), IHCs and additional tests) with the analysis of a blood biopsy. The blood profiling focuses either on the circulating tumor DNA (for deciphering tumor heterogeneity) or in DNA from blood cells (for studying specific germline gene alterations related to BRCAness phenotype that are challenging to detect in FFPE samples). OncoSTRAT&GO establishes a complete genetic profile of the tumor, which can be used to identify sensitivity or resistance to targeted therapies, hormonal therapies, chemotherapies and immunotherapies.
Recommended for The following stage IV solid tumors in adults: Non-small cell lung cancer, HR+, HER2+ and triple-negative breast cancer, Colorectal cancer, Cancer of unknown primary, Ovarian cancer, Pancreatic cancer, Prostate cancer
Specimen 1 block or 25 slides (5 μm on SuperFrost Plus) blood sample (1x10 ml Streck tube or 1x10 ml EDTA tube)
Gene Panel 313 genes for the solid biopsy variable number of genes for the liquid biopsy depending on the cancer type
TAT 15 Working Days
Name OncoSELECT
Description OncoSELECT is a fast and minimally invasive analysis of circulating tumor DNA from a blood sample for lung (NSCLC), colorectal and breast (HR+ or HER2+) cancer patients. It is the perfect solution to identify therapeutic options for cancer patients not able to have their tumor biopsied or whose biopsy is too old. It can be used as a tool to detect treatment resistance to targeted therapies (before first-line to check the heterogeneity of the disease, or during/after treatment to check for acquired resistance mutations), as well as for monitoring cancer progression.
Recommended for The following stage IV solid tumors in adults: Non-small cell lung cancer Breast (HR+ and HER2+) cancer Colorectal cancer
Specimen 2 blood samples (2x10ml Streck tubes)
Gene Panel From 7-12 according to cancer type
TAT 10 working Days
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