FDA nod for Roche and Amgen’s blood testing device - European Medical Journal

FDA nod for Roche and Amgen’s blood testing device

1 Mins
Words by Jade Williams

The FDA has granted Breakthrough Device Designation to Roche’s new blood test, developed in collaboration with Amgen, that measures key blood markers of inherited cardiovascular risk.  

The blood test is designed to measure levels of lipoprotein(a) (Lp(a)) in the bloodstream, biochemical particles made of fat and protein that transport cholesterol and other lipids cells throughout the body, which can lead to an increased risk of developing cardiovascular disease (CVD), such as heart attacks or strokes.

“While modern lifestyles are a major driver, as much as 30% of mortality associated with cardiovascular disease occurs in individuals without modifiable risk factors,” said Matt Sause, CEO, Roche Diagnostics, in a press release. “Through our collaboration with Amgen, Roche is paving the way to make elevated Lp(a) an actionable biomarker.” 

The diagnostic, once fully approved, is expected to be made available to support patients who could benefit from therapies that lower the levels of Lp(a) in the bloodstream.  

Also commenting in the press release, Jay Bradner, Executive Vice President of Research and Development and Chief Scientific Officer, Amgen, said current Lp(a) testing rates are “markedly low”, and existing lab tests may not consistently and accurately measured. He hopes the new test could “equip more patients and healthcare providers with important information to better understand their risk for cardiovascular disease”.

This is an important step forward in the fight against CVD deaths, which remain a major public health problem. According to the British Heart Foundation, there have been an average of more than 500 additional CVD deaths per week in England since the start of the COVID-19 pandemic, with the current extreme and widespread pressure on the NHS cited as one factor.

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