Roche announced that the VENTANA PTEN (SP218) RxDx Assay is the first immunohistochemistry (IHC) companion diagnostic test to receive U.S. Food and Drug Administration (FDA) approval for determining PTEN protein loss, also known as PTEN deficiency, in tumours of patients with prostate adenocarcinoma. These patients may now be eligible for treatment with AstraZeneca?s targeted therapy TRUQAP (capivasertib). PTEN is a tumour suppressor protein and loss of PTEN is commonly observed in a variety of cancers.2 Roche?s test enables patients with PTEN-deficient prostate cancer to potentially benefit from a combination treatment with TRUQAP.
TRUQAP provides a new, first-line treatment option for patients with PTEN-deficient metastatic androgen pathway modulation-naïve or sensitive (mAPMN/S) prostate cancer, previously referred to as metastatic hormone-sensitive prostate cancer (mHSPC). Metastatic hormone-sensitive prostate cancer is an aggressive form of prostate cancer and treatments specifically targeting the PTEN protein loss biology were previously not available. The average length of survival after new, metastatic prostate cancer diagnosis is about 5 to 6 years.4 About 25% of patients with metastatic hormone-sensitive prostate cancer have PTEN-deficient tumors as evaluated by immunohistochemistry (IHC).
Foundation Medicine, an independent affiliate of the Roche Group, is one laboratory using the VENTANA PTEN (SP218) RxDx Assay companion diagnostic kit to help healthcare providers identify patients with PTEN protein loss.
Roche Holding AG (Roche) is a research-based healthcare company. The Company's operating businesses are organized into two divisions: Pharmaceuticals and Diagnostics. The Pharmaceuticals Division consists of two business segments: Roche Pharmaceuticals and Chugai. The Diagnostics Division consists of four business areas: Diabetes Care, Molecular Diagnostics, Professional Diagnostics and Tissue Diagnostics. The Company develops medicines for various disease areas, including oncology, immunology, infectious diseases, ophthalmology and neuroscience. Its pharmaceutical products include Anaprox, Avastin, Bactrim, Bondronat, CellCept, Cotellic, Dilatrend, Dormicum, Invirase, Kadcyla, Kytril (Kevatril), Lariam, MabThera, Madopar, Neupogen, Pegasys, Perjeta, Pulmozyme, Rocaltrol, Rocephin and Roferon-A. The Company offers products for researchers, including cell analysis, gene expression, genome sequencing and nucleic acid purification.
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