BD and the FDA said that a chemical called thiuram found in certain BD blood collection tubes may render results from Magellan's LeadCare blood lead tests inaccurate.

The company plans to launch the system this summer in Europe, aiming to broaden cell-free DNA screening for trisomy 21, 18, and 13.

The prospective analysis suggests that the approach could help clinicians identify patients at risk of a stroke who could benefit from anticoagulant treatment.

The policy states that lab tests without FDA's blessing may pursue local coverage via Medicare contractors, but national coverage requires premarket approval or clearance.

The firm aims to have its test on the European clinical market by early next year, followed by a launch in the US.

The suit alleges that Natera's Panorama test infringes US Patent No. 9,493,831 patent, which covers sequencing library preparation methods applied to maternal blood samples.