Justin Petrone covers consumer genomics, ancestry testing, and the microarray and biochip sector of the genomics market for GenomeWeb.
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.
The project, being coordinated by UCSF and the University of Heidelberg, has a total budget of $20 million and is expected to run through 2025.
The test relies on using quantitative PCR to target genes encoded by prophages — viruses present in Lyme-causing bacteria, which can be easier to detect than the bacteria itself.
The company is positioning the blood-based test as an alternative to invasive chorionic villus sampling, the current standard in Denmark.
While the human toll of the disease has been terrible, IVD makers also report there have been some positive developments, as demand has spiked and familiarity with testing has grown.
Linear Diagnostics, which recently raised £800,000, is also seeking partners to help it market its test platform worldwide.
The test relies on a spermine risk score coupled with a urine test to predict which patients are most likely to have prostate cancer.
The researchers at the Royal College of Surgeons Ireland recently received €1.3 million from Wellcome Trust to support the development of the blood-based test.