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About a year ago, the California company received approval for the flow cytometer from the China National Medical Products Administration.
The additions improve the system's performance and expand its antimicrobial susceptibility testing menu for bloodstream infections.
The test detects the presence of two biomarkers within a single cell associated with HPV infections that can progress to cervical cancer.
The test is designed to detect and differentiate SARS-CoV-2, influenza A, and influenza B and runs on the company's benchtop Cobas Liat system.
The test can be used directly on any open instrument, including portable systems, and it allows for detection of pathogens in about 75 minutes.
Overall, GenMark's ePlex Respiratory Pathogen Panel 2 provides results for more than 20 viruses and bacteria, including SARS-CoV-2, flu A and B, RSV, and rhinovirus.
The company said that dried blood-spot sampling improves access to HIV diagnostic testing and care, particularly among HIV-infected people living in remote areas.
The company received Emergency Use Authorization from the US Food and Drug Administration last month for a SARS-CoV-2 total antibody test.
The community is poised to be the primary channel for stakeholders to communicate PGx concerns with FDA, but it is unclear if all stakeholders will participate.
The BioCheck chemiluminescence tests can process human serum samples in 30 minutes to detect IgG and IgM antibodies.
Verily's test is a modified version of Thermo Fisher Scientific's authorized TaqPath COVID-19 Combo Kit that can be used with pooled samples.
The FDA granted clearance to consumer genetic testing company Ancestry.com for the over-the-counter use of a health risk test for hereditary thrombophilia.
The test provides results for therapeutic drug monitoring in less than five minutes using fingerpick blood.
While it is possible FDA could try to exert authority over such devices, observers suggest that past inconsistency and the recent HHS move make that unlikely.
Healthcare providers need multiplexed tests that can differentiate the flu from the coronavirus so they can treat patients quickly and appropriately.
The test is for use with the company's Liaison MDx instrument and can be used alone or with the Simplexa COVID-19 Direct kit.
BillionToOne's test is based on the company's proprietary Sanger sequencing approach, while Sugentech's test detects antibodies against SARS-CoV-2.
The RT-PCR test runs on the Cobas 6800/8800 Systems and had previously received breakthrough device designation from the FDA.
Veravas' products are used for the detection of biotin, which is often found in multivitamins and over-the-counter health supplements and can interfere with diagnostic test results.
The lateral flow test developed by Mologic to detect IgA, IgG, and IgM antibodies at the point of care has undergone independent validation.