In the field of Personalized Cancer Medicine, we developed assays (ONCOASSAY) based on molecular profiling of tumor, which enable and support patients and their physicians to plan a personalized treatment for cancer patient and monitor their treatment successes.
Personalized diagnostics of breast Cancer
These assays are categorized based their clinical phases:
ONCOASSAY BREAST A (PREVENTION)
ONCOASSAY BREAST A (PREVENTION)
ONCOASSAY BREAST B
The ONCOASSAY breast B is a hybrid immunohistochemical and genomic test for more accurate characterization of breast cancer. ONCOASSAY breast prI combines the specific advantages of immunohistochemistry with that of the genetic approach by qPCR-based gene expression profiling. The immunhohistochemical assessment of prognostic biomarkers is limited to some extent by the semi-quantitative nature of the technology. The ability to exactly define the cellular source of the signals in an often heterogeneous cellular environment of the tumor tissue makes up for that disadvantage. An enormous advantage of the immunohistochemical component of the ONCOASSAY breast prI hybrid system is the fact that these biomarkers had been assessed prospectively. ONCOASSAY breast prI considers not only the activity of a group of proliferation, apoptosis and estrogen hormone receptor associated genes, but also tumor size and lymph node involvement. The ONCOASSAY breast prI algorithm is based on a total of 30 molecular biomarkers complemented by two clinical prognosticators, namely tumor size (pT) and axillary lymph node status (pN). In a two-stage process our computation model first determines the intrinsic phenotype of the individual tumor (Luminal A, Luminal B, HER2/neu, Triple-negative/Basal-like). Subsequently, the risk of recurrence of breast cancer for that specific phenotype is determined which forms the basis for development of a personalized therapy strategy. All these information are summarized in the OA Score (ONCOASSAY Score).
Based on the above basic version of ONCOASSAY breast, complementary tests (ONCOASSAY advanced I-III) will be offered. Depending on OA Score and the individual breast cancer subtype (intrinsic phenotype) the complementary tests offer valuable additional information on the optimal individual treatment strategy. The selective estrogen receptor modulator tamoxifen is routinely used for treatment and prevention of estrogen receptor positive breast cancer. Studies of tamoxifen adherence suggest that over half of patients discontinue treatment before the recommended 5 years. Tamoxifen is metabolized to its more active form by cytochrome P450 2D6 (CYP2D6); decreases in CYP2D6 activity, either by inactivating polymorphisms or drug interactions, can reduce concentrations of tamoxifen’s active metabolites. ONCOASSAY BREAST ADVANCED I (ONCOASSAY TAMOX) can be used to identify patients who should receive tamoxifen therapy and personalized therefore tamoxifen therapy. ONCOASSAY BREAST ADVANCED II is designed for HER2+ patients to analyze the human growth factor receptor 2 pathways and ONCOASSAY BREAST ADVANCED III determines response to different chemotherapeutic agents.
ONCOASSAY BREAST C
ONCOASSAY C is designed to monitor treatment processes and post-treatment care by Liquid biopsies are non-invasive blood tests that detect circulating tumor cells (CTCs) and fragments of tumor DNA that are shed into the blood from the primary tumor and from metastatic sites. Liquid biopsies have grown in importance because; the genetic profile of tumors can affect how well they respond to a certain treatment. . Liquid biopsies have the potential to help clinicians screen for disease, stratify patients to the best treatment and monitor treatment response and resistance mechanisms in the tumor. A liquid biopsy can be used for molecular characterization of the tumor and its non-invasive nature allows repeat sampling to monitor genetic changes over time without the need for a tissue biopsy. ONCOASSAY BREAST C is an assay based on circulating tumor cells for monitoring of breast cancer patient during and after treatment.
ONCOASSAY BREAST D
ONCOASSAY BREAST D is a personalized assay designed for patients with metastatic breast cancer. In this assay, molecular profiling of metastatic tumors is compared to the primary original tumor to determine the personalized treatment option for the patients with metastatic breast cancer. In addition, as 5-FU is a widely used chemotherapeutic agent for metastatic cancer, personalized molecular profiling associated with the 5-FU toxicity is analyzed by ONCOASSAY BREAST D.