The new guidance could benefit Hologic and Roche, both of which market molecular blood screening tests authorized by the FDA under an investigational new drug study protocol.
The company is also developing a next-generation sequencing product that may be applied at the point of need to test for bloodstream infections and later as a liquid biopsy for cancer.
Researchers from both teams plan to continue to refine their findings toward creating simple PCR or other nucleic acid amplification-based assays.
The company said it is confident it can address the state health department's concerns and will reapply for approval as soon as possible.
The diagnostic, a real-time PCR kit for breast cancer stratification, is being reviewed under a special process for the approval of innovative products.
In Science this week: role for epigenetic in neuronal excitability, and more.
The new Office of Research Integrity director is grappling with complaints from her staff, according to ScienceInsider.
Italian researchers link SNPs in the PDSS2 gene to coffee consumption in a new paper.
A gene-editing ban has been interpreted to include mitochondrial transfer, Technology Review reports.