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Roche IL-6 test cleared, identifies high-risk COVID-19 patients
By
LabPulse.com staff writers
The emergency use authorization was granted on June 2 and Roche said that it is available for use on its cobas e analyzers, which are widely available globally. The test is available in countries that accept the CE Mark in addition to the U.S. The cobas analyzers offer throughput of 300 tests per hour and deliver results in approximately 18 minutes, according to the company.
June 3, 2020
Neurofilament light blood test shows concussion damage in study of veterans
By
Emily Hayes
Sponsored by grant funding from the U.S. Department of Defense (DOD) Chronic Effects of Neurotrauma Consortium (CENC), the study evaluated levels of the protein NfL in blood tests and how they correlated with concussion in 195 military veterans. Researchers found higher levels in veterans with a history of three or more concussions compared to those who had not had mTBI. In addition, high NfL was associated with more severe symptoms such as post-traumatic stress disorder (PTSD) and depression.
May 27, 2020
Fluxergy invests $30M to produce more point-of-care SARS-CoV-2 tests
By
LabPulse.com staff writers
The Fluxergy Analyzer test system, which uses polymerase chain reaction (PCR) and microfluidics technology, identified the SARS-CoV-2 virus in less than one hour during bench lab validation studies conducted by the company and in an analysis of patient samples conducted by scientists at the University of California, San Diego (UCSD).
May 12, 2020
MilliporeSigma granted foundational CRISPR-Cas9 U.S. patents
By
LabPulse.com staff writers
The latest allowances mark MilliporeSigma's 25th and 26th CRISPR patents worldwide and the fourth in the U.S. The company is in discussions to license the foundational technology for therapeutic uses and is seeking collaboration partners for research and development.
May 10, 2020
Abbott's 'lightning fast' coronavirus test takes center stage in U.S. pandemic strategy
By
Emily Hayes
The U.S. Food and Drug Administration (FDA) granted an emergency use authorization (EUA) for the polymerase chain reaction (PCR) molecular POC test on March 27. The assay provides positive results in as little as five minutes and negative results in 13 minutes, according to the company.
March 29, 2020
Luminex coronavirus panel gets FDA emergency authorization
By
LabPulse.com staff writers
The NxTag test is designed for use at high complexity laboratories on Luminex' Magpix system, which can handle specimens for up to 96 patients, with results available in approximately four hours, according to the company. Luminex noted that labs can run the CoV test alongside the company's respiratory pathogen panel, which allows differentiation of the new virus from other diseases that have similar symptoms.
March 26, 2020
Qiagen boosts RNA extraction kit production
By
LabPulse.com staff writers
The company plans to reach a global capacity to produce RNA extraction kits to support more than 6.5Â million patient tests per month by the end of April, 10Â million per month by the end of June, and 20Â million per month by the end of the year. It expects to receive the European CE-IVD Mark for the kit soon and is also working with the U.S. Food and Drug Administration (FDA) to secure emergency use authorization (EUA) in the U.S.
March 17, 2020
Fusion Genomics secures $1M U.S. to study respiratory infections panel
By
LabPulse.com staff writers
The Consortium Québécois sur la Découverte du Medicament (CQDM) is a Montreal-based biomedical research consortium that funds new technologies with potential value in facilitating drug discovery and development. The organization noted that since it was founded in 2008, it has raised more than $118 million Canadian ($90 million U.S.) through Canadian government programs and a wide range of pharmaceutical industry partners, including Merck, Pfizer, AstraZeneca, and Eli Lilly.
January 9, 2020
BioMarker Strategies advances immunotherapy test through SBIR grant
By
LabPulse.com staff writers
The contract runs for two years and covers use of the test for predicting response to treatments given alone or in combination to patients with non-small cell lung cancer (NSCLC). This represents the second phase of immunotherapy response test development for the NCI; in the first phase, BioMarker Strategies established proof of concept. Immunotherapies have revolutionized the treatment of several cancer types, but there is a strong need for better ways of identifying patients who benefit, as the objective response rates for PD-1/PD-L1 inhibitors are low, ranging from 10% to 30%.
January 6, 2020
Startup develops POC diagnostic for tuberculosis
By
Joseph Constance
The platform is initially intended for use in South Africa. Eventually, the technology could be applied to detect other organisms responsible for conditions in other geographies.
December 8, 2019
FDA awards $20M to DNAnexus to enhance cloud-based research portal
By
LabPulse.com staff writers
Launched in 2015, the precisionFDA project is a hub for information sharing in bioinformatics approaches and regulatory science surrounding precision approaches for drugs and devices.
December 3, 2019
Cheap vaginal-fluid testing signals risk for premature birth
By
Emily Hayes
The study involved noninvasive testing of 340 women in midtrimester pregnancy, with the goal of identifying two important signs of risk for preterm birth: depletion of Lactobacillus bacteria in the vaginal microbiome and short cervical length, defined as 25 mm. It was funded by grants from the Bill & Melinda Gates Foundation, the Brazilian Ministry of Health, and the Brazilian National Research Council.
October 21, 2019
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