September 8, 2020 Acad, Gov/Utilities Microscopy PR/Corporate

Roche receives FDA clearance for BK virus quantitative test on cobas 6800/8800 Systems to support better care for transplant patients

Immunocompromised transplant patients are at risk of major complications when infected with BK virus cobas BKV test addresses critical need for hospitals and laboratories to have standardised and comparable results across institutions New Breakthrough Device test expands Roche molecular test menu for transplant patients, enabling simultaneous testing of BK virus with Cytomegalovirus and Epstein-Barr virus... Read more

September 7, 2020 Acad, Gov/Utilities Bio/Pharma/CRO

Roche announces FDA approval of Gavreto (pralsetinib) for the treatment of adults with metastatic RET fusion-positive non-small cell lung cancer

Gavreto is a once-daily, oral precision therapy that selectively inhibits RET-altered cancers Genentech and Blueprint Medicines will co-commercialise Gavreto in the United States FDA also granted Priority Review to Gavreto for the treatment of people with advanced or metastatic RET-mutant medullary thyroid cancer and RET fusion-positive thyroid cancer              Basel, 7 September 2020 – Roche (SIX:... Read more

September 4, 2020 Acad, Gov/Utilities Liq. Handling & Robotics Microscopy PR/Corporate

Roche receives FDA Emergency Use Authorization for the cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas 6800/8800 Systems

First commercial test for fully automated high throughput systems to detect and differentiate SARS-CoV-2, influenza A virus and/or influenza B virus with a single sample As COVID-19 and influenza infections can hardly be differentiated based on symptoms, healthcare professionals can confidently provide the right diagnosis and best course of treatment for patients Test for use... Read more

September 1, 2020 Acad, Gov/Utilities Bio/Pharma/CRO Microscopy PR/Corporate

Roche receives FDA approval for first HIV-1/HIV-2 Qualitative Test on the cobas 6800/8800 Systems in the fight against HIV/AIDS

Detects, confirms and differentiates HIV-1 and HIV-2 infections providing clinicians with critical diagnostic data for personalised management of patients with HIV – from appropriate counseling on disease differences to targeted therapy Supports rapid molecular detection of acute HIV infection, which is critical in curbing further disease transmission Combines confirmatory HIV testing and HIV-1/HIV-2 differentiation into... Read more

August 28, 2020 Acad, Gov/Utilities Bio/Pharma/CRO

Roche announces FDA approval of FoundationOne Liquid CDx, a comprehensive pan-tumour liquid biopsy test

FoundationOne Liquid CDx analyses more than 300 cancer-related genes and multiple genomic signatures to help inform treatment decisions for all solid tumour cancers Using a simple blood draw, the test allows more patients with advanced cancer to benefit from the insights of comprehensive genomic profiling, for example when a tissue biopsy is not possible or... Read more

August 24, 2020 Acad, Gov/Utilities

QIAGEN to launch easy-to-use digital test in the U.S. for rapid detection of SARS-CoV-2 antibodies following FDA emergency use authorization

Germantown, Maryland, and Hilden, Germany, August 24, 2020 – QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the U.S. launch of the new Access Anti-SARS-CoV-2 Total test, an easy-to-use digital test done on a portable device that provides results in about 10 minutes to detect antibodies in people exposed to the SARS-CoV-2 virus,... Read more

August 19, 2020 Acad, Gov/Utilities Clinical Research/Diagn. Lab Top-10 Microscopy

Thermo Fisher Scientific Introduces Hematology-Oncology Portfolio for Ion Torrent Genexus System*

Thermo Fisher Scientific Introduces Hematology-Oncology Portfolio for Ion Torrent Genexus System* CARLSBAD, Calif., Aug. 19, 2020 /PRNewswire/ — In hematology oncology, it is critically important to understand the genetics driving acute malignancies to quickly determine how best to address the disease. Today, Thermo Fisher Scientific announces a new portfolio of hematology-oncology assays for the Ion... Read more

August 12, 2020 Acad, Gov/Utilities Lab Top-10

Thermo Fisher Scientific Supports COVID-19 Testing at Historically Black Colleges and Universities Seeking to Provide a Safe Return to Campus

Thermo Fisher Scientific Supports COVID-19 Testing at Historically Black Colleges and Universities Seeking to Provide a Safe Return to Campus WALTHAM, Mass., Aug. 12, 2020 /PRNewswire/ — Thermo Fisher Scientific Inc. (NYSE:TMO), the world leader in serving science, has committed to supporting the efforts of historically black colleges and universities (HBCUs) in the U.S. to... Read more

August 10, 2020 Acad, Gov/Utilities Licensing, IP, and Legal

FDA approves Roche’s Evrysdi (risdiplam) for treatment of spinal muscular atrophy (SMA) in adults and children 2 months and older

Basel, 10 August 2020 In two clinical trials, Evrysdi improved motor function in people living with SMA over a broad spectrum of ages and levels of disease severity, including Types 1, 2, and 3 SMA Evrysdi helped infants survive without permanent ventilation and achieve the ability to sit without support, a key motor milestone not... Read more