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The immune sequencing firm has engaged the FDA in discussions over how to get regulatory approval for one test for several seemingly different diseases.
The multiplexed paper-based assay could rapidly diagnose early-stage Lyme disease more accurately and at a lower cost than existing methods.
The development team said a protein biomarker platform they are developing may differentiate Lyme from other conditions in doctors' offices.
The immunoblots detect IgM and IgG antibodies to Borrelia species, including B. hermsii, B. miyamotoi, and B. turicatae.
The plan focuses on five scientific priorities to advance research and development over the next five years, including developing diagnostic tests for the diseases.
The blood test screens individual blood donations for four common species of the parasite Babesia, which can cause anemia and other potentially fatal conditions.
The immune sequencing firm is working on kit-ifying its two existing tests, as well as developing a second clinical test and expanding the label for clonoSeq.
The clearance marks the first time that the tests have been indicated to follow a new paradigm in which two enzyme immunoassay tests can be conducted concurrently or sequentially, the FDA said.
The first tests to be made available through the collaboration will be for Lyme disease and food sensitivity, leveraging PerkinElmer's expertise.
The collaboration aims at automating the processing of up to 96 liquid biopsy samples at one time using Enable Bio's (ADAP) technology for immunoassays.