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.
The test will combine Qiagen's QuantiFeron (interferon-gamma release assay) technology with DiaSorin's Liaison automated analyzers.
The collaboration between 15 federal and state groups used a workshop format originally developed by CDC to help other countries with their One Health issues.
The test is immunoassay-based and detects multiple targets using the firm's automated testing system called the BioPlex 2200.
Bluejay said that the collaboration will focus on the study of antigens associated with various pathogens and identifying the most immunoreactive antigen.
The company also reaffirmed fiscal fourth quarter growth expectations including double-digit growth in the US for its TB testing products.
The firm has added two new targets to make the Sofia 2 POC Lyme+ Fluorescent Immunoassay more relevant to Lyme disease pathogens in Europe.