March 24, 2020 Acad, Gov/Utilities Lab Top-10 PAI Top-10

FDA Provides Emergency Use Authorization to PerkinElmer for COVID-19 Testing

WALTHAM, Mass.–(BUSINESS WIRE)–Mar. 24, 2020– PerkinElmer, Inc. (NYSE: PKI), a global leader committed to innovating for a healthier world, announced today that the U.S. Food and Drug Administration (FDA) has provided Emergency Use Authorization (EUA) for the Company’s New Coronavirus RT-PCR test. Clinical laboratories certified under Clinical Laboratory Improvement Amendments (CLIA) can immediately begin using... Read more

March 24, 2020 Acad, Gov/Utilities Liq. Handling & Robotics Product Launch

QIAGEN releases QIAstat-Dx test kit to the U.S. as first syndromic test for detection of SARS-CoV-2 coronavirus under new FDA Policy

Germantown, Maryland, and Hilden, Germany, March 24, 2020 – QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that it has begun shipments to the United States of its new QIAstat-Dx Respiratory SARS-CoV-2 Panel test to aid in diagnosing patients infected with the novel COVID-19 coronavirus under a new Policy of the U.S. Food and... Read more

March 14, 2020 Acad, Gov/Utilities Clinical Research/Diagn. Lab Top-10

FDA Issues Emergency Use Authorization to Thermo Fisher Scientific for Diagnostic Test Used to Detect COVID-19

FDA Issues Emergency Use Authorization to Thermo Fisher Scientific for Diagnostic Test Used to Detect COVID-19 WALTHAM, Mass., March 13, 2020 /PRNewswire/ — Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, announced today that the U.S. Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for its diagnostic test that... Read more

March 13, 2020 Acad, Gov/Utilities PR/Corporate

Roche’s cobas SARS-CoV-2 Test to detect novel coronavirus receives FDA Emergency Use Authorization and is available in markets accepting the CE mark

First commercial test for SARS-CoV-2 will enable expedited coronavirus testing to meet urgent medical needs Testing on widely available, high-volume cobas 6800/8800 will significantly increase available testing capacity Roche expedites test development to support urgent need for patient testing during pandemic outbreak to avoid a further spread of the virus at an early stage of... Read more

March 11, 2020 Acad, Gov/Utilities Bio/Pharma/CRO PR/Corporate

Roche receives FDA approval for CINtec PLUS Cytology test to aid clinicians in improving cervical cancer prevention

Next-generation cytology test provides additional information for HPV-positive women who may have cervical pre-cancer More sensitive than Pap cytology testing when used as triage test for HPV-positive screening results, helping to improve the detection of cervical pre-cancer The first biomarker-based test specifically approved by the FDA to triage women with HPV-positive / Pap cytology-negative co-testing... Read more

March 4, 2020 Acad, Gov/Utilities Atomic Spectroscopy

FDA grants Breakthrough Device Designation for Roche's Elecsys GALAD score to support earlier diagnosis of hepatocellular carcinoma

The Elecsys GALAD score aims to support clinicians in diagnosing hepatocellular carcinoma by giving them more timely and accurate information to make earlier interventions When hepatocellular carcinoma is detected and managed at the very earliest, patient’s 5-year survival rates can increase to over 70%1 Utilizing blood-based biomarkers, as part of the Elecsys GALAD score, is... Read more

February 25, 2020 Acad, Gov/Utilities

FDA accepts Roche’s Biologics License Application for fixed-dose subcutaneous combination of Perjeta and Herceptin for HER2-positive breast cancer

Fixed-dose combination administered under the skin in just minutes, compared to hours with intravenous administration, significantly reducing time spent receiving treatment US Food Drug and Administration is expected to decide on approval by 18 October 2020 Basel, 25 February 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug... Read more

February 24, 2020 Acad, Gov/Utilities Lab Top-10 Liq. Handling & Robotics PAI Top-10

Luminex Corporation Submits VERIGENE® II Respiratory Flex Assay for FDA Clearance

AUSTIN, Texas, Feb. 24, 2020 /PRNewswire/ — Luminex Corporation (NASDAQ: LMNX) today announced that the company has submitted an application to the U.S. Food and Drug Administration (FDA) for 510(k) clearance of the VERIGENE® II Respiratory Flex Assay, the second VERIGENE II assay to be submitted to the agency. The VERIGENE® II Respiratory Flex (RSP Flex) Assay... Read more

February 19, 2020 Acad, Gov/Utilities

FDA grants priority review to Roche’s Tecentriq monotherapy as first-line treatment of certain people with advanced non-small cell lung cancer

Basel, 19 February 2020 – 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 a first-line (initial) monotherapy for people with advanced non-squamous and squamous non-small cell lung cancer (NSCLC) without... Read more