FDA Further Expands EUA for Thermo Fisher Scientific's COVID-19 Diagnostic Tests

Authorization brings more instruments on line, enables workflow flexibility and simplifies methods to increase throughput and allow more labs to run tests WALTHAM, Mass., May 12, 2020 /PRNewswire/ — Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, today announced that the U.S. Food and Drug Administration (FDA) has further expanded emergency... Read more

FDA Provides Emergency Use Authorization to PerkinElmer for Serological Test to Identify COVID-19 Antibodies

WALTHAM, Mass.–(BUSINESS WIRE)–May 5, 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 EUROIMMUN’s (a PerkinElmer company) Anti-SARS-CoV-2 ELISA (IgG) serology test. Clinical laboratories certified to perform high complexity tests under Clinical... Read more

Roche’s COVID-19 antibody test receives FDA Emergency Use Authorization and is available in markets accepting the CE mark

The serology test has a specificity greater than 99.8% and sensitivity of 100% (14 Days post-PCR confirmation) The high specificity of the test is crucial to determine reliably if a person has been exposed to the virus and if the patient has developed antibodies Roche will provide high double-digit millions of tests already in May... Read more

Microscopy Techniques for Energy Materials

WILEY ebook provides an overview of how microscopy can be applied in energy materials research. Download the ebook and read about: Microscopy techniques & their benefits for energy materials research Microscopy-enabled accomplishments in energy materials research (11 short versions of selected peer-reviewed articles from various WILEY journals) Current challenges & future developments in microscopy applications for energy materials (Interview with... Read more

Roche receives FDA approval for cobas HPV test for use on the cobas 6800/8800 Systems to identify women at risk for cervical cancer

More than 99 percent of cervical cancers are caused by persistent high-risk HPV infection1 Cervical cancer is nearly 100 percent preventable with proper HPV vaccination, screening and treatment; expanding access helps reach more women2,3 cobas 6800/8800 Systems deliver full automation, helping laboratories meet the throughput and efficiencies that high-volume, HPV DNA screening programs require              Basel,... Read more

US FDA and EMA accept applications for Roche’s OCREVUS (ocrelizumab) shorter 2-hour infusion time

Reduces infusion time to 2 hours from the current 3.5 hours for patients with relapsing or primary progressive multiple sclerosis, if approved Applications are based on data from the randomised, double-blind ENSEMBLE PLUS study, showing consistent safety to the currently approved OCREVUS dosing regimen              Basel, 20 April 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY)... Read more

Luminex Receives FDA Emergency Use Authorization for ARIES® SARS-CoV-2 Assay to Detect Virus Responsible for COVID-19 Disease

AUSTIN, Texas, April 6, 2020 /PRNewswire/ — Luminex Corporation (NASDAQ: LMNX) today announced that the Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for its ARIES® SARS-CoV-2 Assay for rapid detection of the virus that causes COVID-19. The assay runs on the ARIES® System, an FDA-cleared, sample-to-answer, automated, on-demand molecular diagnostic platform.... Read more

QIAGEN receives U.S. FDA EUA for QIAstat-Dx test kit, first and only syndromic solution integrating detection of SARS-CoV-2 coronavirus

Germantown, Maryland, and Hilden, Germany, March 31, 2020 –QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that it has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its newly developed QIAstat-Dx Respiratory SARS-CoV-2 Panel test for use in diagnosing patients infected with the novel COVID-19 coronavirus. The QIAstat-Dx... Read more

Luminex Receives FDA Emergency Use Authorization for NxTAG® CoV Extended Panel to Detect the SARS-CoV-2 Virus that Causes COVID-19 Disease

AUSTIN, Texas, March 27, 2020 /PRNewswire/ — Luminex Corporation (NASDAQ: LMNX) today announced that the Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for its NxTAG® CoV Extended Panel. The intended use of this multiplex test is the detection of the SARS-CoV-2 virus. High complexity molecular laboratories can now use the NxTAG test... Read more