Justin Petrone covers consumer genomics, ancestry testing, and the microarray and biochip sector of the genomics market for GenomeWeb.
Eighty-two test providers received a letter from the UK Competition and Markets Authority this week that warned them not to mislead or mistreat customers.
In particular, the diagnostics company expects the new resource to strengthen its offerings to pharmaceutical partners, a key customer group.
The company has used RNA sequencing to discover its marker set but plans to transition the assay to a PCR platform before it seeks regulatory clearance.
The Cologne, Germany-based company this week raised €4 million ($4.7 million) in a Series A financing round and plans to use the funds for developing its first test.
The Manchester, UK-based company had previously planned to have a CE-IVD marked test out by June 30.
The French firm is developing panels for respiratory diseases, gastrointestinal ailments, women's health, urinary tract infections, sexually transmitted diseases, and meningitis.
Plans are underway to make the test, which provides results in five minutes, available clinically in both single and multiplex formats.
The constellation of challenges to implementing the IVDR by next year have prompted players to openly call for its postponement and phased implementation.
The workflow relies on flow cytometry data coupled with a cell population detection method and a machine learning classifier to produce a diagnosis.
The company intends to invest its $32 million in IPO proceeds on human resources, R&D, and expanding to international markets, with the US a particular target.