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The device is designed to stabilize RNA and DNA from fingerstick blood at room temperature for up to two weeks so that it can be mailed to a lab for analysis.
The specimen discard technology automatically and passively "sidelines" potential contaminants during the blood culture collection process, Kurin said.
The company reported performance changes that led to the product recall and said it is pursuing eventual FDA clearance for the devices.
Genentech will use Adaptive's ClonoSeq assay for MRD testing in a CLL study. Adaptive will receive upfront and sample testing payments of undisclosed amounts.
The firm is performing a clinical trial for Finder in preparation of a 510(k) submission to the FDA, anticipated in early 2020, it said.
In the long term, the company is developing a plan to create more tests based on its technology, which digitizes blood samples and turns them into images.
Companies in the AMR space have met resistance from investors and clinicians as a result of conflicting hospital priorities and perceived technology shortcomings.
The Australian Red Cross Blood Service will use the Alinity s System to process its blood tests and improve lab automation.
The developers anticipate that their new approach may enable noninvasive and continuous monitoring of glucose, lactate, and other clinical parameters.
The Royal Oak, Michigan-based startup will use the funding to support development and commercialization of its pan-disease diagnostic testing platform.