Close Menu

More articles about Regulatory News & FDA Approvals

The firm's CEO said that the deprioritization of its submission for a standalone SARS-CoV-2 assay running on its Verigene I molecular diagnostic instrument is puzzling.

While the tests from Clinomics, UPenn, and Inno Diagnostics detect the SARS-CoV-2 virus, Princeton BioMeditech's test differentiates between SARS-CoV-2 and influenza.

Mologic will help Avacta secure CE marking for one of its SARS-CoV-2 tests, as well as assist it with test manufacturing and distribution.

The new indication states that determining counts of certain immune cells may be useful in the assessment of patients with COVID-19

The test is less invasive than Roche's existing rapid antigen test for SARS-CoV-2, which collects its sample from the nasopharynx.

The device also has Emergency Use Authorization from the US Food and Drug Administration and has CE marking for in vitro diagnostic use.

Since August, Abbott said it has shipped 200 million Panbio tests to 120 countries globally, although it is not available in the US.

The test uses primers and probes from Thermo Fisher Scientific's authorized TaqPath COVID-19 Combo Kit with a modified results interpretation algorithm.

Fluidigm's Advanta Dx SARS-CoV-2 RT-PCR assay is an extraction-free saliva-based test to detect nucleic acid from the SARS-CoV-2 virus.

Bio-Rad's PCR-based test is designed to detect SARS-CoV-2 nucleic acid, while United Biomedical's test detects antibodies against the virus.

The kit was jointly developed by Singapore's Agency for Science, Technology, and Research, Tan Tock Seng Hospital, and MiRxes.

The test has been authorized for use with individual respiratory specimens, as well as with pooled specimens containing up to five samples.

The company continues to face regulatory challenges in the US, but received CE marking for its DPP SARS-CoV-2 Antigen and IgM/IgG test systems.

The fluoro-enzyme immunoassay is designed for the qualitative and semi-quantitative detection of immunoglobulin G against SARS-CoV-2.

Ortho said that it currently can deliver 5 million tests per month and will be able to increase that figure to 15 million tests per month in February.

The kits are designed to run on Theradiag's i-Track 10 testing system and the IDS-iSYS automated analyzer from Immunodiagnostic Systems.

The lateral flow test can be used at the point of care and provides results within 15 minutes without the need for additional equipment, the company said.

Separately, Siemens said that it has received CE marking for the use of its Clinitest Rapid COVID-19 Antigen Test with an additional specimen type.

The firm also provided preliminary revenues of $950 million for Q4 and reinstated guidance of $3.79 billion to $3.88 billion for 2021.

The liquid biopsy test, Colvera, detects aberrant methylation in BCAT1 and IKZF1, two genes found at a high frequency in colorectal cancer tissue.