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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.
Genetron's S5 sequencer is based on Thermo Fisher's Ion GeneStudio S5 instrument and is cleared for clinical use by China's NMPA.
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.
Along with predicting preeclampsia, the Delfia Xpress sFlt-1 kit can be used to help diagnose the condition in the second and third trimesters of pregnancy.
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 framework is meant to guide healthcare providers in facilitating prostate cancer genetic testing in a timely and responsible way, the researchers said.
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.
In December the firm won $4 million from CARB-X to support the platform's first test identifying the most common bloodstream infections associated with sepsis.
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 said the contract will help it complete development of the ELISA test and submit for Emergency Use Authorization with the FDA.
The Illumina COVIDSeq Test is a high-throughput, in vitro diagnostic that provides results in 24 hours. The test is for use with the NovaSeq 6000 Sequencing system.
The firm developed the total antibody test for use on its Dimension analyzers alongside its development for its Advia Centaur and Atellica analyzers.
The test is the second from Euroimmun to receive EUA from the agency. Its antibody test received the designation last Month.
NeoGenomics will offer the Thyroid Profile and the NGS Thyroid Profile plus RET FISH test as part of the program, which is sponsored by Lilly.
A pilot study will be conducted to examine the integration of the Biosensor platform with an assay system to detect IgM and IgG antibodies.
Thermo will develop a test using its Oncomine Precision Assay to identify IDH1- and IDH2-positive low-grade glioma patients for treatment with Agios' vorasidenib.
The decision comes after Myriad requested expanded coverage for women with breast cancer seeking information about extending endocrine therapy.
The firms said they will focus on increasing Randox’s manufacturing capacity for biochips including those used in SARS-CoV-2 tests.
The New York-based firm will use the funding to develop and clinically validate its personalized, real-time tool for monitoring recurrence and treatment response for various sold cancer types.
The Swiss company said the higher revenues were driven by an 11 percent year-over-year increase in revenues from its Alba reagent business.
The lawmakers requested the secretary to direct money from the Public Health and Social Services Emergency Fund to support clinical labs.