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The firm's CEO said that its MDx system is available for research use and going through CE-IVD marking ahead of its full commercial launch.
The firm expects an expanding market for at-home self-testing and is differentiating its products in part through their ease of use.
XPhyto said it is in discussions with potential distribution and wholesale partners as well as potential licensees for the SARS-CoV-2 molecular test.
The new pathway allows developers of authorized tests that meet certain requirement to immediately obtain a screening claim.
Bio-Techne expects the acquisition will provide it with a basis to build out its IVD presence, given Asuragen's diagnostic tests and regulatory expertise.
The firm said it has developed a POC test that uses a biomarker for HPV16, which is responsible for more than 90 percent of all HPV-related head and neck tumors.
The firm said it will use the financing to develop and commercialize its immune response gene-expression diagnostic tests.
According to the company, the test is 98 percent sensitive and 100 percent specific for detecting SARS-CoV-2, in both symptomatic and asymptomatic individuals.
The silver amplification immunochromatography-based test is designed to detect SARS-CoV-2 antigens nasopharyngeal swab samples within 13 minutes.
iAssay plans to evaluate a COVID-19 incorporating each firm's technology in support of a submission to FDA for possible Emergency Use Authorization.
DiaSorin got the green light for its Liaison Anti-HAV chemiluminescent immunoassay to detect total antibodies to the hepatitis A virus.
Linear Diagnostics, which recently raised £800,000, is also seeking partners to help it market its test platform worldwide.
Talis, which went public last month, develops point-of-care infectious disease tests based on its flagship Talis One sample-to-answer platform.
The assay from San Diego-based Cue is the first molecular test authorized by the US Food and Drug Administration for home use without a doctor's prescription.
The tests are expected to become widely available to consumers through supermarket chains, drug stores, pharmacies, and online sales starting March 6.
FDA has signaled via public comments that it is flexible on test performance specs, but firms remain wary of falling short of official agency requirements.
Danaher’s guidance of double-digit top-line growth for 2021 provides upside opportunities that depend mostly on the success of vaccine rollouts, Barclays said.
After nearly a year in development, the firm's rapid antigen test will be submitted by the end of March for a prescription-use claim.
The test is designed to help determine if a patient has an acute respiratory infection and if that infection is bacterial or viral.
The investment bank said that Lucira's COVID-19 single-use test could have widespread use with potential for adoption in the over-the-counter markets.