Roche (OTCQX:RHHBY) announced today that it appointed Brad Moore as president and CEO of Roche Diagnostics North America. Indianapolis-based Roche Diagnostics North America said Moore’s appointment becomes effective Jan. 1, 2023. He currently serves as SVP of core lab and point of care within Roche Diagnostics North America. He succeeds and reports to Matt Sause, whom […]
Roche Diagnostics
Roche Diagnostics promotes from within to fill corner office
Roche (OTCQX:RHHBY) announced that it promoted Matt Sause to CEO of Roche Diagnostics. Sause, 45, currently heads up Roche Diagnostics’ North America Region. His move to the corner office and to the company’s executive committee becomes effective Jan. 1, 2023. The Basel, Switzerland-based company appointed current Roche Diagnostics CEO Thomas Schinecker to CEO, effective March […]
New authorized Roche COVID-19 test can also detect viral loads
Roche announced today that it received FDA emergency use authorization (EUA) for its cobas SARS-CoV-2 Duo diagnostic. Authorization covers the cobas SARS-CoV-2 Duo on the fully automated cobas 6800/8800 systems, expanding Roche’s COVID-19 portfolio and representing the first automated, RT-PCR assay for the in vitro qualitative and quantitative detection of SARS-CoV-2 RNA in nasal and […]
Roche says its research-only COVID-19 tests can detect a range of variants, subvariants
Roche announced today that its TIB Molbiol subsidiary has made available testing solutions that can identify a number of COVID-19 variants. Basel, Switzerland-based Roche’s testing offerings can identify the SARS-CoV-2 (the virus causing COVID-19) B.1.1.529 variant and differentiate between the omicron subvariants BA.1, BA.1.1, BA.2, BA.2.2, BA.3 and delta, according to a news release. VirSNiP […]
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 […]
AdvaMed unveils COVID-19 diagnostic supply registry
AdvaMed announced today that it created a comprehensive national COVID-19 diagnostic supply registry to aid state and federal pandemic responses. According to a news release, AdvaMed is launching the registry in partnership with 13 commercial diagnostics manufacturers: Abbott (NYSE:ABT), Becton Dickinson (NYSE:BDX), bioMérieux, Bio-Rad Laboratories (NYSE:BIO), Beckman Coulter, Cepheid, Hologic (NSDQ:HOLX), Ortho Clinical Diagnostics, Qiagen (NYSE:QGEN), Roche Diagnostics, Sekisui Diagnostics, […]
Roche Diagnostics win FDA EUA for COVID-19 antibody test
Roche Diagnostics has received FDA emergency use authorization (EUA) for its Elecsys Anti-SARS-CoV-2 COVID-19 antibody test. The test will identify antibodies to determine if a person has ever been infected with the coronavirus. The presence of SARS-CoV-2 antibodies in human serum or plasma can also indicate an adaptive immune response. Switzerland-based Roche has begun shipping […]
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 […]
FDA doubles down on warfarin test strip recall
The FDA this week alerted patients and doctors about test strips used to monitor levels of the blood thinner warfarin, expanding and reiterating its warning that the products shouldn’t be used to adjust a person’s drug dosage. The agency’s latest notice is related to the Class I recall of Roche‘s CoaguChek meters and test strips, which […]
FDA issues Class I recall for Roche Diagnostics’ warfarin test strips
The FDA today issued a Class I recall for certain lots of Roche Diagnostics‘ warfarin test strips used with the CoaguCheck test meter devices. Roche voluntarily recalled the strips in September, warning that for patients and doctors who use at-home devices to monitor levels of the blood thinner, the devices may yield inaccurate results. The FDA said today […]
DeviceTalks Q&A: Regulatory experts talk medtech policy
A panel of regulatory experts convened at DeviceTalks Minnesota this year to chat with MassDevice.com editor Sarah Faulkner. The group of regulatory experts included Danelle Miller, VP of regulatory policy & intelligence at Roche Diagnostics; Megan Brandt, VP of regulatory affairs and quality assurance at CHF Solutions (NSDQ:CHFS); and Mac McKeen, regulatory science fellow at Boston Scientific (NYSE:BSX). Faulkner: We […]
