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The PCR test detects HIV-1 RNA on the NeuMoDx 96/288 Molecular Systems and joins the company's other bloodborne viral tests for hepatitis B and C.
The disease occurs when cytomegalovirus infection is passed from a mother to an unborn child and can lead to severe and potentially fatal outcomes.
The PCR-based tests are designed to detect SARS-CoV-2 nucleic acid in various respiratory specimens including nasopharyngeal swabs.
Lexent Bio's monitoring platform is in development and based on low-pass whole-genome sequencing and DNA methylation analysis.
The Tucson, Arizona-based firm signed agreements with Denmark-based BioNordika, Czech Republic-based Explorea, and Bulgaria-based Elta 90.
KidneyIntelX can be used to report risk assessment results for fast-progressing kidney disease and future kidney failure for patients with chronic kidney disease.
Cue Health's test is authorized for use at the point of care, while Tide and TBG's PCR-based tests are performed by CLIA-certified laboratories.
Clinicians at Addenbrooke's Hospital in the UK are seeing reduced time to result and additional clinical benefits from using the DRW SAMBA II SARS-CoV-2 assay.
Under the LCD, pharmacogenomic tests are covered when medications are being considered for use that are known to have a clinically actionable gene-drug interaction.
Warrior Diagnostics' RT-PCR test detects SARS-CoV-2 RNA in nasopharyngeal swab samples and uses the same primers and probes as the CDC SARS-CoV-2 test.
CareDx, which focuses on transplant medicine, said it intends to use the proceeds from the offering for working capital and general corporate purposes.
Menarini said the test, which detects IgG and IgM antibodies, is available in the US based on receipt of an FDA EUA by its manufacturer, Healgen Scientific.
The firm said it intends to use the credit facility to support its US and European commercial paper programs and for general corporate purposes.
The firm said that the proceeds will be used to complete the development of the Cue Health Monitoring System and Cue Test Cartridges.
The experts said that antibody testing cannot indicate an individual's immunity or help with return-to-work schemes but have use for public health agencies.
The test detects SARS-CoV-2 from nasopharyngeal swab specimens and runs on standard qPCR instruments, including Thermo Fisher's Applied Biosystems 7500 Fast machine.
To enable the use of saliva in addition to other types of samples, Sysmex requested a change to a marketing approval it obtained in March.
The firm developed the total antibody test for use on its Dimension analyzers alongside its development for its Advia Centaur and Atellica analyzers.
In January a federal court unsealed a False Claims Act suit from an industry insider that alleges a Myriad subsidiary engaged in a fraudulent kickback scheme.
The decision comes after Myriad requested expanded coverage for women with breast cancer seeking information about extending endocrine therapy.