Diadexus, a diagnostics company developing and commercializing products that aid in assessing the prognosis of cardiac disease, has signed an agreement with Sonic Healthcare USA to release the company's PLAC Activity Test into Sonic's national network of laboratories.
The PLAC Test for Lp-PLA2 Activity is the only Food and Drug Administration (FDA)-cleared test used in conjunction with clinical evaluation and patient risk assessment as an aid in predicting the risk of coronary heart disease (CHD) in patients with no prior history of cardiovascular events, a population representing approximately 75 percent of CHD patients.
Lori Rafield, chairman and chief executive officer (CEO) for Diadexus, said: "Sonic is the first laboratory to offer the PLAC Activity Test nationally with commercial activities in multiple states and an extensive network of 14 laboratories, over 250 customer collection sites, and approximately 100 sales representatives.
“They are also part of a leading worldwide provider of laboratory services, which could expand access to this new test internationally in the future."
She added: "Our experienced sales and marketing team is already working with Sonic's commercial team, and validation has been completed. We are both committed to a successful and expedited product launch to make the PLAC Activity Test available broadly to healthcare providers and conveniently to patients through customer collection sites nationally.
Rafield said healthcare providers want tests supported by extensive clinical data and FDA clearance to help inform decisions in managing patients under their care. She said the clinical utility of the PLAC Activity Test as an independent marker to predict CHD risk is supported by extensive published research.
“We look forward to working collaboratively with Sonic to grow the market significantly by educating healthcare providers and raising the awareness of this valuable new tool for managing patients at risk for this disease,” she added.
Diadexus, Sonic Healthcare USA, Cardiac disease, Lori Rafield, Healthcare, US