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The firm posted $29.7 million in revenues, up about 15 percent from $25.8 million in Q4 2018 and slightly above the analysts' average estimate of $29.5 million.

Leadership aims to lower cost of goods and real estate footprint, while driving test utilization by targeting clinicians. 

Funded by a five-year, $3.7 million NIH grant, the firm plans to offer an assay that is cheaper and less invasive than standard upper endoscopies. 

FDA declined to comment on how or when it might respond to the request, which comes as reagent problems delay distribution of tests to public health labs.

The nanosensors will target low-cost, handheld diagnostics and are expected to be able to detect and quantify specific molecules in biofluids in 30 seconds.  

The partners are validating three rapid diagnostic test prototypes prior to initiating a trial in the Democratic Republic of the Congo during March 2020.

The firm placed 45 of its T2Dx diagnostics instruments in 2019, but plans to reduce that number in 2020 to focus on instrument utilization.

The firm said its revenues for the three months ended Dec. 31, 2019 were $62.9 million compared to $32.9 million in the same quarter of 2018.

The company said it will use the proceeds for general corporate purposes, such as the repayment of debt, working capital, and possible acquisitions.

The collaboration will support the development of rapid diagnostics, including point-of-care tests, and therapeutics, according to a statement.

PerkinElmer is providing its recently FDA-approved test for the program, which has identified one baby, so far, as positive for DMD.

The Logix Smart Coronavirus COVID-19 test can now be sold as an IVD in markets that accept CE-marking as valid regulatory approval, the company said.

The company is in talks with potential partners in the US and China to validate the assay on clinical samples and deploy it at a large scale.

The urine-based test, which was already available in several markets, does not require any specialized instrumentation and produces results in less than three minutes.

The kits can detect more than 1,000 antimicrobial resistance gene variants, including mobilized colistin resistance (mcr) and extended-spectrum beta lactamases.  

The company said it expects to launch the Verigene II system with respiratory and gastrointestinal assays in the middle of this year.

LabCorp will be the exclusive provider of the test, which uses next-generation sequencing to look for actionable mutations cell-free DNA in NSCLC patients.

The firm will use the funding to expand access to its microbial cell-free DNA technology to help doctors diagnose infectious disease.

Australian researchers said that in a preliminary study they saw sensitivity improvements by adding IL-6 to other clinical measurements.

Genetron will provide clinical trial genomic testing and companion diagnostic development services for InnoCare's biomarker-driven oncology drug development.

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