Medical associations and device companies have largely come out against a Trump administration proposal to permanently exempt certain medical devices and software from the FDA 510(k) clearance process. HHS used Trump’s waning days in office to propose permanently exempting 83 Class II devices and one unclassified device from the clearance review process. The list includes home ventilators, […]
Roche
MedTech 100 roundup: Small dip keeps industry down
The last month brought a bit of a skid for the medtech industry and after a slight rebound last week, the downward trend has returned. A strong start to 2021 came to an end in late February and carried over into March, with MassDevice‘s MedTech 100 index hitting its lowest point on March 8 (102.16). It […]
Roche to acquire GenMark Diagnostics for $1.8B
Roche (SWX: RO, ROG) announced that it entered into an agreement to acquire GenMark Diagnostics (NSDQ:GNMK) for $1.8 billion. Basel, Switzerland-based Roche is set to purchase GenMark at $24.05 per share in an all-cash transaction, totaling approximately $1.8 billion on a fully diluted basis. That represents a premium of approximately 43% to GenMark’s unaffected closing […]
Roche launches SARS-CoV-2 variant test for research use
Roche (SWX: RO, ROG) today announced that it has launched its Cobas SARS-CoV-2 Variant Set 1 test to detect mutations in the COVID-19 virus. The test is designed to differentiate mutations found in variants that originated in the U.K. (B.1.1.7), South Africa (B.1.351) and Brazil (P.1). It runs on its high-volume Cobas 6800/8800 systems and is a research […]
FDA reports problems with Roche combo test for COVID-19 and flu
The FDA released an alert warning of false-positive results with Roche’s (SWX: RO, ROG) Cobas SARS-CoV-2 & Influenza A/B nucleic acid diagnostic. Roche’s Cobas COVID-19/flu combo test runs on its Cobas Liat system. According to an FDA release, the false-positives may be related to two issues observed by the company. The company observed that the assay tubes […]
Roche obtains CE Mark for rapid COVID-19 test with easier nose collection
Roche (SWX: RO, ROG) announced today that it received CE Mark approval for its new SARS-CoV-2 nasal rapid antigen test. Basel, Switzerland-based Roche’s nasal test collects the sample from the front area of the nose instead of the nasopharynx, which is the method used with its existing SARS-CoV-2 rapid antigen test. The new method results in a simplified […]
What are the most effective COVID-19 antibody tests?
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 […]
Roche launches high-volume antigen test in Europe
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, 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 […]