The company is currently conducting clinical studies to validate AlloSure's technology — which underlies its kidney transplant test — in lung transplant patients.
The test showed 90 percent sensitivity and 75 percent specificity in a 250-patient blinded study, even without the addition of clinical risk information.
The test combines the superior performance of laboratory-based PCR tests and the simplicity and convenience of traditional POC rapid immunoassays, the firm said.
Abbott said that the next-generation molecular POC assays have also been CLIA waived for use on the Abbott ID NOW instrument, formerly called Alere i.
The agency's regulatory plan differs in key areas from a draft of the Diagnostic Accuracy and Innovation Act that had shored up lab industry support.
The test, which uses automated reverse-transcription real-time PCR, expands the firm's menu of CLIA-waived tests for use in near-patient and point-of-care settings.
The company is developing a proprietary technology for the detection of RNA- and DNA-based genetic alterations in blood samples.
Seventeen organizations don't support the Diagnostic Accuracy and Innovation Act as written and would like lawmakers to advance a CLIA-centric framework.
A Bloomberg reporter tried to get her genetic data deleted, but found it's not so simple to do.
The test, which received FDA clearance in late 2017, runs in as little as 18 minutes.
Bloomberg reports that the DNA-for-cash deal reported in Kentucky might be a more widespread scam.
St. Jude Children's Research Hospital scientists have treated infants with X-linked severe combined immunodeficiency using gene therapy in an early phase study.
St. Louis Public Radio reports that some African Americans are turning to DNA ancestry testing to help guide genealogical searches.
In Nature this week: a genomic analysis of the snailfish Pseudoliparis swirei, ancient DNA analysis gives insight into the introduction of farming to England, and more.