BD alleges Cytek hired away former BD employees to develop flow cytometry products to compete against BD.
According to CEO Eugene Chan, the CE designation is just the first of more to come, as the company enters the diagnostics market with a focus on hematological testing.
Through the new lab, NeoGenomics can work with pharmaceutical clients through the different phases of drug development, including the development of companion diagnostics.
The firm has been offering its StatRes test through a deal with St. Joseph Health and is now looking to sign similar agreements with other hospital systems.
The firm had been notified by the exchange in August that it failed to meet a listing requirement calling for a minimum $1 bid price on its stock.
The company is developing a test based on computational quantitation of a subtype cells called MDSCs, which play a role in the tumor microenvironment.
The instrument, which the company is launching this week at the AACC annual meeting, allows for measurement of up to 12 parameters in individual cells.
The company's new FACSLyric flow cytometer system is for use with BD Multitest assays for assessing suspected immunological deficiencies in patients.
A Quest spokesperson confirmed the acquisition of Dignity Health Sierra Nevada Memorial Hospital, the latest in a string of buys by the clinical laboratory giant.
The test, the agency said, is the first authorized by it for use with flow cytometry to detect leukemias and lymphomas.