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The firm said its deep-learning software automates the reading and analysis of diagnostic test results including for SARS-CoV-2 lateral flow antigen tests.
News items for the in vitro diagnostics industry for the week of March 8, 2021.
The firm recently in-licensed distribution of an Emergency Use Authorized SARS-CoV-2 antigen assay it expects to launch in March 2021.
iAssay plans to evaluate a COVID-19 incorporating each firm's technology in support of a submission to FDA for possible Emergency Use Authorization.
GetMyDNA's direct-to-consumer sample collection kit is used with a PCR-based SARS-CoV-2 test from affiliate Gravity Diagnostics.
Despite challenges related to the coronavirus pandemic, the Chinese precision oncology firm reported total quarterly revenues of RMB131.7 million ($20.2 million).
The program will identify new pathogens, analyze potential risk level, develop and deploy new diagnostic testing, and assess the public health impact.
The companies have agreed to join their respective technologies into an integrated product for artificial intelligence-based prostate cancer diagnosis.
Prequalification from the World Health Organization indicates that products meet high quality standards and are safe for their intended use.
Zymo Research previously received CE-IVD marking for the collection device, which enables the transport and storage of SARS-CoV-2 RNA at ambient temperatures.
The company offers a digital platform designed to simplify genetic test ordering and results reporting, and recently launched a workflow for COVID-19 testing.
Quidel's guidance announcement cited an approximately 40 percent decrease in demand for its SARS-CoV-2 tests.
The lateral flow test is designed to detect immunoglobulin G antibodies against SARS-CoV-2 in a finger prick blood sample and returns results in 20 minutes.
The firm said its test can be used to evaluate blood samples from people who present with suspicious growths in the breast, lung, prostate, colon, or brain.
Under the five-year agreement, Amazon has made an undisclosed investment in KMPM and is supporting the firm's Lattice integrated diagnostic data platform.
The deal covers Agena's MassArray platform for genetic variant measurement, as well as genetic testing applications and other related products.
DiaSorin got the green light for its Liaison Anti-HAV chemiluminescent immunoassay to detect total antibodies to the hepatitis A virus.
Leinco will use the antibodies for diagnostic applications and will make the antibodies commercially available as part of their research tools catalog.
Patients with genomic profiling test results showing potential inherited cancer gene variants will be able to undergo genetic counseling and follow-up germline testing.
Paige said it will use the financing to expand its geographic footprint as it accelerates the development of artificial intelligence-based clinical applications, biomarkers, and diagnostic tests.
Avacta said it would receive royalties on future sales of any products that are commercialized following completion of product development and regulatory approvals.
The Agilent SARS-CoV-2 qRT-PCR Dx kit detects N1 and N2 targets from SARS-CoV-2 RNA isolated and purified from nasopharyngeal swab specimens.
Until Tuesday midday, German states could order a total of 10.5 million Rapid Antigen Nasal Tests for self-testing that Roche will start delivering on Wednesday.
Talis, which went public last month, develops point-of-care infectious disease tests based on its flagship Talis One sample-to-answer platform.
The test, which detects the SARS-CoV-2 N gene, was previously granted Emergency Use Authorization for use with samples collected by a healthcare provider.