FDA Clears Thermo Scientific EliA SmD(P)-S Test For Use In U.S. New blood test is designed to reduce the number of false positive results and provide improved diagnostic guidance in Systemic Lupus Erythematosus PORTAGE, Mich., Aug. 26, 2021 /PRNewswire/ — Thermo Scientific EliA SmDP-S test has been cleared by the U.S. Food & Drug Administration (FDA) for... Read more
FDA Approves NGS-Based Companion Diagnostic for Previously Treated IDH1-Mutated Cholangiocarcinoma CDx approval expands clinical utility of Oncomine Dx Target Test to identify candidates for TIBSOVO CARLSBAD, Calif., Aug. 25, 2021 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) has granted pre-market approval to Thermo Fisher Scientific’s Oncomine Dx Target Test as a companion diagnostic (CDx) to... Read more
Cancer is the second leading cause of death worldwide, with nearly 10 million deaths annually.1, 2 In the U.S., approximately 1.9 million new cancer cases are expected to be diagnosed in 2021.1 Based on cancer biomarkers, the first-of-its-kind VENTANA MMR RxDx Panel helps determine which solid tumour patients may benefit from GSK immunotherapy. Roche/GSK collaboration... Read more
FDA Grants Emergency Use Authorization for Two Next-Generation COVID-19 Assays from Thermo Fisher Scientific CARLSBAD, Calif., Aug. 16, 2021 /PRNewswire/ — Thermo Fisher Scientific, the world leader in serving science, today announced that the U.S. Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for the TaqPath COVID-19 Fast PCR Combo Kit 2.0 and... Read more
Basel, 3 August 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for Tecentriq® (atezolizumab) as adjuvant treatment following surgery and platinum-based chemotherapy for people with non-small cell lung cancer (NSCLC) whose tumours... Read more
Across four phase III studies, approximately half of patients receiving faricimab could extend treatment time to every four months – the first time this level of durability has been achieved in phase III nAMD and DME studies If approved, faricimab would be the first and only medicine designed to target two distinct pathways that drive... Read more
Non-invasive sampling method makes it easier to use the highly sensitive molecular test manufactured by PerkinElmer WHAT: PerkinElmer, Inc., a global leader committed to innovating for a healthier world, today announced that the U.S. Food and Drug Administration (FDA) has authorized the PerkinElmer® New Coronavirus Nucleic Acid Detection Kit for an additional indication that permits... Read more
Every year in the US, approximately 10,000 people are diagnosed with myelodysplastic syndromes (MDS), and there remains a high unmet need for new treatment options1 The designation is based on interim results from the phase Ib M15-531 study investigating Venclexta/Venclyxto plus azacitidine in people with previously untreated higher-risk MDS This is the 11th Breakthrough Therapy... Read more
Immune repertoire assays offer high detection rates of malignant clones, empowering researchers to better assess blood cancers CARLSBAD, Calif., July 19, 2021 /PRNewswire/ — Thermo Fisher Scientific today announced a new suite of Ion Torrent Oncomine immune repertoire assays designed to detect potentially malignant clones of T-cells and B-cells, which play a key role in the immune... Read more