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Yourgene will provide molecular COVID-19 testing to corporate clients of Caxton, who will obtain their results through Hooha Innovations' Prova app.
Roche will have non-exclusive access to SpeeDx's existing tests and technology to enable expansion of diagnostic products for antibiotic resistance in STIs.
The company recently agreed to pay millions to three major insurers under settlement agreements related to allegations over undisclosed past business practices.
The Beijing-based company offers genomics products and services, including PCR instruments and cancer sequencing, and maintains a research center in the US.
The test has 100 percent sensitivity and almost 100 percent specificity, and the company has ramped its manufacturing capacity to deliver 30 million tests per month.
The Rostock, Germany-based company reported €12.1 million ($13.6 million) in revenues, missing the average analyst estimate of $14.7 million.
The test has been developed to run on Illumina's NextSeq 550Dx next-generation sequencing platform and will be prepared for commercial launch in Europe.
Dante Labs will use library preparation kits from Nonacus and software from CCG.ai to create a sample-to-report service, the firms said.
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.
News items for the in vitro diagnostics industry for the week of June 8, 2020.
The technology from Scanwell is also being used for its at-home SARS-CoV-2 antibody test, which is under development and awaiting Emergency Use Authorization.
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.