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The system detects Zika virus IgM antibodies in human serum, potassium-EDTA plasma, potassium-EDTA venous whole blood, or fingerstick whole blood specimens.
Phosphorus' test is authorized for use with saliva samples collected by healthcare providers or patients at home using DNA Genotek's collection kit.
The new method uses Takara Bio's SmartChip PCR instrument, chips, and reagents to run 5,184 reactions per chip in less than 30 minutes.
Hologic received clearance for a change to a probe reagent in the Aptima Combo 2 assay to detect variants of Chlamydia trachomatis that have emerged recently.
ArcherDx has leveraged next-generation sequencing to develop and commercialize more than 325 research-use-only products and a pan-solid tumor diagnostic test.
The test is designed to detect a nucleic acid sequence from the SARS-CoV-2 E gene in various respiratory specimens including nasal swabs.
Private equity firms KKR and Ampersand Capital have reportedly proposed acquiring Oxford Immunotec for around $15 per share in cash.
Finland-based Medix Biochemica said the acquisition of US-based EastCoast Bio broadens its antibody and antigen offering in several diagnostic areas.
Some of the additional data required includes the patient's age, race, ethnicity, sex, and residence zip code, along with info about the ordering provider.
The company said it has also received Emergency Use Authorization from the US Food and Drug Administration for its nucleic acid extraction kit.
Its authors said the guidance provides a focus on how clinicians can get the most efficacy and highest quality results from implementing best practices.
News items for the in vitro diagnostics industry for the week of June 1, 2020.
CDC Director Robert Redfield told a congressional subcommittee about the test, for which the center plans to seek Emergency Use Authorization from the FDA.
The company said it is recruiting 200 staff members in science, engineering, and manufacturing to support its role within a national SARS-CoV-2 testing program.
The test measures levels of interleukin 6, which is an indicator for acute inflammation and can be used to identify COVID-19 patients at high risk of intubation.
The Swedish company said it will use the funds in part to accelerate the commercialization of its PanCan-d test for early-stage pancreatic cancer detection.
The company said its ELISA assay uses the SARS-CoV-2 nucleoprotein as an antigen for the early detection of antibodies against SARS-CoV-2.
The PCR-based tests, which detect regions in the virus' nucleocapsid gene, may only be performed at their developers' CLIA-certified labs.
The first year's pilot phase aimed to develop an infectious disease digital health and precision medicine platform connecting healthcare facilities to NYSDOH.
he firm will use the proceeds to expand manufacturing capacity for its existing and in-development COVID-19 assays.
The technologies, called non-extensible oligonucleotides and linear DNA assembly, may help the sample prep firm improve existing products.
The company, along with Softbank Investment Advisers, is offering a total of 11.5 million shares of its common stock at $84 per share.
Sienna said that Unilabs, a commercial lab in Sweden, is evaluating its hTERT bladder cancer test for routine use.
In its complaint, the Maryland-based company claimed that Natera infringes two of its patents, both titled "Methods for detection of genetic disorders."
The company plans to use the funds for general corporate purposes, including, together with cash on hand, to repay borrowings under its term loan facility.