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For the three months ended March 31, the firm reported revenues of $9.2 million, up from $6.0 million in the year-ago quarter and beating the consensus Wall Street estimate of $8.9 million.
The firm said that its RAQ SARS-CoV-2 PCR Kit allows the replacement of full nucleic acid extraction with a simple heat treatment, decreasing sample processing time.
The algorithm provides automated assessments of objective and reproducible scanned slide images that can help with diagnosis and targeted treatment options.
Both PCR-based tests are designed to detect SARS-CoV-2 nucleic acid in upper respiratory specimens and may only be performed by their developers.
News items for the in vitro diagnostics industry for the week of June 22, 2020.
Recent guidance from HHS has improved data collection by clarifying which testing data all laboratories must report, including demographic data.
The cancer molecular diagnostics firm said it will use the proceeds from the offering to support its R&D activities and for general corporate purposes.
Kidney disease diagnostic company RenalytixAI is planning a public offering of its American Depositary Shares and a concurrent private placement.
The two PCR-based tests are designed to detect SARS-CoV-2 nucleic acid in respiratory samples including nasopharyngeal swabs and bronchoalveolar lavage specimens.
Babson recently signed an agreement to provide SARS-CoV-2 serology testing services for a study being conducted at the University of Texas at Austin.
Among the brands comprising Calibre are Alpha-Tec Systems, EdgeBio, Microlytic, Molecular Dimensions, and NexTal, which it acquired from Qiagen earlier this year.
The lab company is taking full ownership of MACL, the largest independent clinical lab in the state, which it formed as a joint venture around 20 years ago.
University of Oxford said the program will assemble experts with experience in generating the robust evidence required for a test to be used in the UK NHS.
Gencurix' RT-PCR-based test detects SARS-CoV-2's Orf1-ab and RdRP genes, while Laihe's assay is designed to detect antibodies against the virus.
The self-testing device is designed for the measurement of urine pH levels in patients taking alkalizing and acidifying urinary treatments.
Birx suggested labs should help communicate science to at-risk communities, including Hispanic populations, which have seen the highest proportion of illness.
William Hughes, the owner and operator of the Greensburg, Pennsylvania-based lab, made cash payments for referrals between October 2011 and August 2013.
The point-of-care SARS-CoV-2 quantitative serology test measures IgM and IgG antibodies and returns results in five minutes.
The assay will identify patients with mutations in HER2 who may be eligible for treatment with a HER2-directed antibody-drug-conjugate developed by Daiichi.
The companies are developing a lung cancer liquid biopsy assay that will run on desktop sequencers, with plans to apply for regulatory clearance in China.
BioSkryb will now have an exclusive global license for clinical applications of primary template directed amplification technology.
The company sells a number of next-generation sequencing-based tissue and liquid biopsy tests for cancer therapy selection to the Chinese market.
By combining with ArcherDX, Invitae will gain tumor profiling and liquid biopsy technologies for predicting and monitoring therapeutic response.
The findings underscore the utility of universal germline testing in young adults diagnosed with cancers that are more common in older populations.
The tests are designed to detect regions in the SARS-CoV-2 genome in respiratory samples or antibodies against the virus in human serum, plasma, or blood.