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Roche

What are the most effective COVID-19 antibody tests?

December 14, 2020 By Sean Whooley

The FDA released a list of emergency use authorized COVID-19 antibodies to offer comparisons over the sensitivity of the diagnostics. Among the larger companies on the list with larger sample sizes, antibody tests made by Roche and Siemens were some of the highest-ranking diagnostics, according to the FDA comparison. Tests are in part described by […]

Filed Under: Diagnostics, Featured, Food & Drug Administration (FDA), Genomics/Molecular Diagnostics, Regulatory/Compliance Tagged With: Abbott, coronavirus, COVID-19, FDA, Roche, Siemens

Roche launches high-volume antigen test in Europe

December 11, 2020 By Sean Whooley

Roche (SWX: RO, ROG) announced today that it launched a high-throughput SARS-CoV-2 antigen test on the European market. Basel, Switzerland-based Roche said in a news release that the antigen test is designed as an aid in the diagnosis of SARS-CoV-2, the virus causing COVID-19, in markets accepting the CE Mark. Roche has also filed for FDA emergency […]

Filed Under: Business/Financial News, Diagnostics, Featured, Genomics/Molecular Diagnostics Tagged With: coronavirus, COVID-19, Roche

Roche, Diabeloop partner on insulin pump management

December 11, 2020 By Sean Whooley

Roche (SWX: RO,  ROG) announced today that it is partnering with Diabeloop to advance insulin pump therapy management. Basel, Switzerland-based Roche said in a news release that the partnership will create new opportunities to lower the burden of constant insulin dose adjustment for those with diabetes while also improving therapy outcomes. Get the full story at our sister […]

Filed Under: Business/Financial News, Diabetes, Patient Monitoring Tagged With: Diabeloop, Roche

Which COVID-19 diagnostics are most sensitive?

December 4, 2020 By Sean Whooley

The FDA SARS-CoV-2 Reference Panel released a comparison pitting COVID-19 diagnostics against each other for superior sensitivity. Developers of the diagnostics are asked to perform a range-finding limit of detection (LoD) for detectable units per mL, according to the FDA release. The PerkinElmer New Coronavirus Nucleic Acid Detection Kit and the Viracor SARS-CoV-2 assay led […]

Filed Under: Diagnostics, Featured, Food & Drug Administration (FDA), Genomics/Molecular Diagnostics, Regulatory/Compliance Tagged With: Abbott, coronavirus, COVID-19, Hologic, PerkinElmer Inc., Roche, Zymo

Qiagen readies portable digital COVID-19 antigen test

November 12, 2020 By Brian Buntz

Qiagen (NYSE: QGEN) and its partner Ellume are gearing up for the launch of the QIAreach SARS-CoV-2 antigen test, which can reportedly process samples in 2–15 minutes. Qiagen notes that the test can process up to 30 swab samples per hour while supporting parallel processing of antibody tests. The companies have submitted the test for […]

Filed Under: Business/Financial News, Diagnostics Tagged With: Abbott, antigen test, coronavirus, COVID-19, Qiagen N.V., Roche

Imbio, Genentech partner on AI for lung imaging

October 7, 2020 By Chris Newmarker

Imaging AI company Imbio has partnered with the Roche Group’s Genentech business to develop quantitative imaging diagnostics for lung diseases. The multi-year agreement, announced yesterday, leverages Minneapolis-based Imbio’s expertise to build and deploy medical imaging AI technology for use in research, clinical trials and clinical practice. “We are excited to partner with Genentech and we […]

Filed Under: Diagnostics, Health Technology, Imaging, Software / IT Tagged With: AI, artificial intelligence, Genentech, Imbio, Roche

Roche test for both COVID-19 and influenza receives EUA

September 4, 2020 By Chris Newmarker

Roche (SWX: RO,  ROG) announced today that the FDA has granted an EUA for its Cobas SARS-CoV-2 and Influenza A/B Test for use on Cobas 6800 and 8800 systems. The test is also available in nations accepting the European Union’s CE Mark. The new Roche test can provide simultaneous qualitative detection and differentiation of SARS-CoV-2, […]

Filed Under: Diagnostics, Featured, Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: coronavirus, COVID-19, Roche

Roche to compete against Abbott with fast COVID-19 antigen tests

September 2, 2020 By Chris Newmarker

Roche (SWX: RO,  ROG) plans to launch a SARS-CoV-2 rapid antigen test that doesn’t need lab equipment to process results — similar to the test that Abbott (NYSE:ABT) recently launched. Roche’s test will launch late this month in Europe, initially making 40 million tests available per month. The Swiss pharma and diagnostics giant plans to also […]

Filed Under: Diagnostics, Featured Tagged With: Abbott, coronavirus, COVID-19, Roche, Roche Diagnostics

What kinds of COVID-19 tests are out there?

July 10, 2020 By Nancy Crotti

Months into the pandemic, the FDA continues to grant emergency use approval (EUA) to new tests to detect the virus that causes COVID-19 and the antibodies that indicate a person has had it. To date, the FDA has granted EUAs for 171 tests —142 molecular tests, 27 antibody tests, and 2 antigen tests. Given the ever-changing […]

Filed Under: Diagnostics, Featured, Genomics/Molecular Diagnostics, Research & Development Tagged With: Abbott, coronavirus, COVID-19, DiaSorin, FDA, Mayo Clinic, Roche

Abbott: ID NOW COVID-19 results more accurate with earlier testing

May 21, 2020 By Nancy Crotti

Abbott (NYSE:ABT) said today that its ID NOW COVID-19 test works better on specimens collected soon after patients begin showing symptoms. The test’s performance has drawn fire from federal officials in recent weeks, including a recent FDA warning that the ID NOW test may return false-negative results. The agency granted the test an emergency use authorization […]

Filed Under: Business/Financial News, Diagnostics, Featured, Food & Drug Administration (FDA), Genomics/Molecular Diagnostics, Research & Development, Wall Street Beat Tagged With: Abbott, coronavirus, COVID-19, Everett Clinic, FDA, Johns Hopkins, Roche, U.S. Centers for Disease Control and Prevention

5 companies on the front lines of the coronavirus fight

March 23, 2020 By Nancy Crotti

Nancy Crotti, Managing Editor and Danielle Kirsh, Senior Editor Amid the stock market roller-coaster ride that began last month, medtech companies that make devices and diagnostic tests vital to fighting COVID-19 may ultimately fare better than others, but it’s hard to tell until the virus peaks and people get back to work. At midafternoon today, […]

Filed Under: Business/Financial News, Cardiovascular, Diagnostics, Featured, Hospital Care, Orthopedics, Respiratory, Spine, Wall Street Beat Tagged With: 3m, Abbott, Baxter, becton dickinson, coronavirus, Danaher Corp., Johnson & Johnson, Medtronic, Philips, Roche, Thermo Fisher Scientific

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