Roche has announced that its Ventana PTEN (SP218) RxDx assay is the first immunohistochemistry (IHC) companion diagnostic test to receive FDA approval in the United States for identifying PTEN protein loss, also known as PTEN deficiency, in tumors of patients with prostate cancer.
'In prostate cancer, the loss of the PTEN protein is associated with faster disease progression and reduced benefits from current standard treatments,' the Swiss healthcare group stated.
The new Roche test addresses an unmet medical need by helping clinicians identify patients with PTEN protein loss who may benefit from combination treatment with AstraZeneca's targeted therapy, TRUQAP (capivasertib).
TRUQAP offers a new first-line treatment option for patients with PTEN-deficient metastatic castration-sensitive prostate cancer (mCSPC), formerly known as metastatic hormone-sensitive prostate cancer (mHSPC), following androgen pathway modulation.
According to the Swiss pharmaceutical laboratory, this FDA approval reinforces its leadership in the field of companion diagnostics and its ongoing commitment to expanding personalized care to improve patient outcomes.
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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