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The firm is completing a clinical study that it hopes will facilitate the launch of its AST system that provides results in four hours after a positive blood culture.
The Seattle-based firm believes its novel collection devices are convenient and safe enough to use at home to draw blood for many types of tests.
Healthcare providers need multiplexed tests that can differentiate the flu from the coronavirus so they can treat patients quickly and appropriately.
The Harvard University spinout uses a combination of proprietary probes, nanoarrays, and convection PCR to target a broad set of molecular biomarkers.
The firm said its ELISA multiplex SARS-CoV-2 test may enable early diagnosis of infected patients and broaden the number of testing options at the point of care.
The company said the nanowire technology it has been developing to detect traumatic brain injury also has the potential to enable rapid testing for SARS-CoV-2 at the point of care.
The firm anticipates soon receiving FDA clearance for future products, including an AI-based prostate cancer detection system that received CE marking in 2019.
In a preliminary study, the group reported high accuracy for the detection of breast cancer within an hour by combining a fluorescence flow cytometer with fine-needle biopsies.
The company said that in response to the letter, it is recalling all non-Luminex temperature verification fixtures from the field for its Verigene SP instrument.
The firm said that it has begun developing its own products using synthetic affinity reagent technology acquired five years ago from the University of Leicester.