Shots: The US FDA has approved the new VENTANA HER2 Dual ISH DNA Probe Cocktail assay to detect HER2 biomarker in BC and as a CDx for Herceptin (trastuzumab) therapy. The assay was launched as a CE IVD in Apr’2019 The assay is designed to be completed within the same day, enabling clinicians to get […]Read More
Shots: QIAGEN launches its therascreen BRAF V600E RGQ PCR Kit as a CDx to Pfizer’s Braftovi (encorafenib) in combination with Lilly’s Erbitux (cetuximab) for the treatment of patients with m-CRC with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy The therascreen BRAF V600E kit runs on QIAGEN’s Rotor-Gene Q MDx […]Read More
Shots: The alliance will validate multiple biomarkers to be used in Thermo Fisher’s Oncomine Dx Target Test, which will be used to identify variant-positive patients for enrollment into clinical studies focusing NSCLC and may follow other cancer indications The ability of the Oncomine Dx Target test to rapidly detect variants from small quantities of DNA/ […]Read More
Shots: Promega and Merck collaborated to develop Promega’s microsatellite instability (MSI) technology as an on-label solid tumor CDx for use with Merck’s Keytruda (pembrolizumab) Promega’s Microsatellite Instability technology measures the genomic accumulation of insertion or deletion (INDEL) errors caused by a deficient mismatch-repair system (dMMR) occurring in a solid-tumors, used to characterize tumors and guide […]Read More
Shots: The companies collaborated to develop companion diagnostic utilizing Thermo Fisher’s Oncomine Dx Target Test for the identification of RET-altered NSCLC and thyroid cancer patients who may be treated with Lilly’s LOXO-292 Thermo Fisher will retain rights to commercialize its test in all markets including the US, EU and Japan. Post validation, Thermo Fisher will […]Read More
Shots: The US FDA approved FoundationOne CDx as a CDx for Lynparza (co-developed & co-commercialized by Merck & AstraZeneca) for 1L maintenance therapy in BRCA-mutated advanced ovarian cancer The test detects both germline and somatic mutations in BRCA1 and BRCA2 tumors and identify more patients to get benefit from Lynparza in comparison to other testing […]Read More
Shots: Janssen and Resolution Bioscience develops Resolution’s HRD liquid biopsy test as a companion diagnostic for Janssen’s Niraparib, being investigated for the treatment of metastatic castration-resistant prostate cancer The Resolution HRD assay will allow Janssen to identify patients with prostate cancer who may benefit from Niraparib therapy. In 2016, Janssen got exclusive WW license from […]Read More
Shots: Roche’s Ventana HER2 Dual ISH DNA Probe Cocktail assay is used to detect HER2 biomarker in breast and gastric cancer patients receiving Herceptin (trastuzumab) The approval of Ventana HER2 Dual ISH assay supports Roche’s personalized healthcare sector by providing techniques to diagnose breast and gastric cancer The Ventana HER2 assay is fully automated on […]Read More
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