The agency said its aim is to analyze the way CMS has chosen to implement PAMA and to estimate the potential financial impact to Medicare as a result of those choices.
Changes in physician behavior around monitoring patient response to therapeutic monoclonal antibodies is increasing demand for clinical testing of these drugs.
Investigators calculated that the new assay, which includes 67 SNPs, could offer a 50 percent improvement over previous methods if used in newborn screening.
The Polish company recently received 9 million Polish złoty ($2.4 million) from the country's National Center for Research and Development to support its activities.
Clinical laboratories are increasingly adopting molecular assays as an alternative to the tedious, time-consuming stool cultures that have long been the mainstay for testing patients who might have infectious diarrhea or conditions such as Salmonella or Campylobacter. With an estimated 1.7 billion cases of childhood diarrheal disease occurring annually around the world, this is a significant advance for gastroenteritis testing.
