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 nasopharyngeal swab specimens.

The assay performs quantitation of SARS-CoV-2 RNA levels in the connected specimen, while only the qualitative result of cobas SARS-CoV-2 Duo is intended for use as an aid in the diagnosis of SARS-CoV-2 infection in patients suspected of COVID-19 by their healthcare provider.

Basel, Switzerland-based Roche said in a news release that the potential benefits from reporting a standard viral load along with the qualitative result may help clinicians assess and monitor infected patients across laboratories over time.

The company plans t…

Read more
  • 0

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 SARS-CoV-2 Spike S371L S373P and VirSNiP SARS-CoV-2 Spike S371L S373P 452R are Roche’s research use-only tests now available, adding to the test kits previously developed by Roche and TIB Molbiol for detecting recent BA.1 and BA.2, as well as other mutations, present in the novel B.1.1.529 omicron SARS-CoV-2 variant.

The company said TIB Molbiol’s researchers work in collaboration with academic contacts to continually screen for new variants and emerging diseases.

“Roche is pleased to offer testing options addressing the ongoing COVID-19 he…

Read more
  • 0

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 seek an emergency use authorization from U.S. FDA, and will double production by the end of the year.

The test can provide results within 15 minutes. It has a sensitivity of 96.52% (positive percent agreement) and a specificity of 99.68% (negative percent agreement), based on 426 samples from two independent study centers, according to Roche.

Roche is launching the rapid antigen test in partnership with SD Biosensor, with whom Roche has a global distribution agreement

“Especially in the upcoming flu season, it is important to know whether a person has SARS-CoV-2 or the flu to ensure the righ…

Read more
  • 0

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, Siemens Healthineers (ETR: SHL), and Thermo Fisher Scientific (NYSE:TMO).

The AdvaMed registry is designed to compile information from the diagnostic companies, along with public data, to create a centralized and standardized COVID-19 diagnostic supply registry to update on weekly numbers at state and national levels regarding molecular, antigen and serology tests shipped in the U.S.

AdvaMed said in the release that the registry will also help streamline communicati…

Read more
  • 0