The FDA has conducted an administrative acceptance review on the 510(k) submission of the PLAC test for Lp-PLA2 activity, and it was found to contain all of the necessary information needed to proceed with the substantive review.
diaDexus chief technical officer Emi Zychlinsky said: "We have been working closely with the FDA through the pre-submission process to determine a path forward to obtain US clearance for the Activity Test, and we are pleased that we are now one step closer in the regulatory process.
"We have been focused on adding the PLAC test for Lp-PLA2 Activity to our product offering as it is performed on high throughput clinical chemistry analyzers and is designed to improve productivity and increase value for all of our customers, both cardiovascular specialty laboratories and large clinical laboratories."
diaDexus has already obtained CE Mark approval for the PLAC Test for Lp-PLA2 activity and it is available in the EU.
