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 […]
Roche
Roche, Diabeloop partner on insulin pump management
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 […]
Which COVID-19 diagnostics are most sensitive?
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 […]
Qiagen readies portable digital COVID-19 antigen test
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 […]
Imbio, Genentech partner on AI for lung imaging
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 […]
Roche test for both COVID-19 and influenza receives EUA
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, […]
Roche to compete against Abbott with fast COVID-19 antigen tests
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 […]
What kinds of COVID-19 tests are out there?
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 […]
Abbott: ID NOW COVID-19 results more accurate with earlier testing
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 […]
5 companies on the front lines of the coronavirus fight
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, […]
Roche secures emergency use authorization for coronavirus test
Roche (SWX: RO, ROG) announced today that its Cobas SARS-CoV-2 test is the first commercially distributed diagnostic test to receive an FDA emergency use authorization during the coronavirus pandemic. The tests are also now available in countries accepting the EU’s CE Mark. FDA didn’t object to Roche pre-positioning its test, so labs are now able to initiate testing […]
