Roche Diagnostics has received the US Food and Drug Administration (FDA) 510(k) approval for its Tina-quant Lipoprotein (a) Gen.2 Molarity assay to measure lipoprotein in a person’s bloodstream.

Together with clinical evaluation and other lipoprotein tests, the lipoprotein assay is intended to measure the number of Lp(a) particles per litre in a person’s bloodstream.

The test helps clinicians evaluate lipid metabolism disorders and atherosclerotic cardiovascular disease risk and take actionable steps to reduce the diseases.

Roche said that Tina-quant is the first FDA-approved test in the US, to measure lipoprotein (a), or Lp(a), in nanomoles per litre (nmol/L), and will be available on its cobas c systems.

Roche Diagnostics North America president and CEO Brad Moore said: “We are proud to support the National Lipid Association’s recommendation for Lp(a) testing, emphasising accurate cardiovascular risk assessment with the first FDA-cleared test measuring in nmol/L units in the US.

“Roche has an unrivalled ability to provide access to testing at scale and is committed to advancing innovation in preventive cardiology.

“This clearance comes in advance of disease-modifying therapies on the horizon expected to help clinicians use this biomarker to guide patients to improved cardiovascular health.”

According to Roche, Lp(a) is emerging as a key risk factor for cardiovascular disease, as it has been associated with an increased risk of cardiovascular (CV) events.

Elevated levels of Lp(a) have been shown to promote the buildup of lipids in artery walls creating plaques, formation of clots and increasing aortic valve calcification.

Therefore, Lp(a) testing can help clinicians make a more accurate assessment of CV risk, and it is expected to become a part of regular diagnostic testing in the future.

Over 90% of the Lp(a) level is influenced by variations in the genes controlling the Lp(a) particle production, where lifestyle interventions such as diet and exercise have no impact.

According to the National Lipid Association (NLA), all adults are recommended to measure their Lp(a) (L-P-Little-A), at least once in a lifetime to evaluate cardiovascular risk.

In addition, the Canadian Cardiovascular Society, European Atherosclerosis Society, European Society of Cardiology and the Beijing Heart Society also recommend Lp(a) measurement.

UC San Diego School of Medicine Department of Cardiovascular Medicine professor Pam Taub said: “Through no fault of our own, Lp(a) levels are determined at birth by genetics and thought to be unaffected by lifestyle changes, with approximately 20% of individuals living with elevated levels of this particle.

“With the opportunity to now consistently and accurately measure Lp(a) in particle concentration units, and anticipated Lp(a)-lowering treatments coming to market, clinicians have an opportunity to help their patients understand and potentially lower their cardiovascular risk.”