The company, which changed its name from Premaitha Health last month, saw a 73 percent increase in testing volumes during the first half of fiscal year 2018.
The partners are developing a point-of-care diagnostic kit that they anticipate will concurrently test for up to 20 types of infectious diseases in 20 minutes.
Led by investigators at the University of Trento in Italy, the team received a five-year, £5 million ($6.4 million) award recently to advance its work.
The UK developers believe that their device has the potential for multiplex testing at the point of care using solid-state nanopore sensing with DNA probes.
The high-sensitivity test runs on the Quidel Triage Meter Pro instrument and joins a growing list of similar tests that have recently received regulatory approvals.
The draft guidance has been reissued with updates based on industry comments and is intended to lay out the steps necessary to get simultaneous 510(k) and CLIA waiver approval.
Factors that may have led to the explosion in testing include more consultations between patients and general practitioners, and a fear among GPs of being sued.
The LeukoStrat CDx FLT3 Mutation Assay is a PCR-based test for internal tandem duplications and tyrosine kinase domain mutations D835 and I836 in the FLT3 gene.
NeoGenomics estimates that the more than 2,000 community oncologists represent a $2.5 billion testing opportunity. Its CEO called the segment a "strategic priority."
The new 250,000 square-foot facility will be modeled after the company's Lab of the Future in Marlborough, Massachusetts, and will employ more than 1,100 people.
