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The company's Curian immunoassay instrument is currently in front of the FDA, and the PediaStat will likely be submitted later this year.

The agency compiled the evolving list by drawing on information from drug labeling and the published literature and is asking stakeholders to provide feedback.

The two organizations are collaborating to perform a standardized evaluation of currently available molecular diagnostic tests to assess test performance.

The PAVmed subsidiary will have the option to license the biomarkers for a year after the completion of a Phase II study evaluating their accuracy.

OpGen, which is acquiring Curetis, said that combined revenue for both companies would have been about $6 million in 2019 had the deal been completed last year.

Invitae reported $66.3 million in revenues for the fourth quarter, which fell short of the consensus Wall Street estimate of $68.1 million.

The groups have written draft recommendations and are now asking for public comment from pathologists and other stakeholders.

The plan piggybacks on national influenza surveillance, testing flu-negative samples using the CDC's rRT-PCR test for the novel coronavirus.

The agreement will bring Exalenz's BreathID Breath Test Systems, a urea breath test platform for H. pylori detection, into Meridian's portfolio.

The company plans to use the funds to fuel its diagnostic development work, focused on predicting drug response in various autoimmune diseases.

The companies will join their respective technologies to provide pharmacogenomic information for patients undergoing genetic testing.

The single-tube real-time PCR-based test has also received CE marking, according to Seegene, and is now commercially available.

CareDx first sued Natera in April 2019, accusing the company of trying to mislead patients and clinicians about the superiority of its Prospera transplant test.

The firm said that it has received 288,000 requests for quotations for the test since it was made available for preorder on Feb. 14.

Consumers have filed complaints about the San Diego-based firm's questionable business practices and lack of response in the last year. 

The program aims to consent up to 150,000 patients to a larger biobank program and return selective preemptive PGx results through their medical center physicians.

The Shenzhen Mammoth Public Welfare Foundation, which BGI sponsors, has also raised funding to purchase PCR and automate sample preparation instruments.

The genotyping test is designed to identify cancer patients with a metabolic disorder that can result in toxicity to a common cancer therapeutic.

The proposed Medicines and Medical Devices Bill updates the framework for regulating IVDs following the UK's exit from the EU.

The Series B round, which includes new and existing investors, follows the Belgian firm's completion of a €7.7 million private placement in 2016.

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