In This Article:
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Roche's Tina-quant Lipoprotein (a) Gen.2 Molarity assay.
This is said to mark the first assay of its kind in the US to measure lipoprotein (a), also known as Lp(a), in nanomoles per litre (nmol/L).
As per the National Lipid Association (NLA) recommendation, all adults should measure their Lp(a) at least once to evaluate the risk of cardiovascular disease.
This is crucial for evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular disease (ASCVD) risk in combination with other lipoprotein tests.
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.”
Unlike traditional mass units (mg/dL), the Tina-quant Lipoprotein (a) Gen.2 assay quantifies Lp(a) in terms of particle number per litre of blood, which is the preferred method within the scientific community due to the variable size of Lp(a) particles.
Clinicians and laboratory professionals can now rely on molar unit measurements to know the Lp(a) particle numbers, bypassing the variability in particle size.
The assay is conducted through a routine blood draw and measures the concentration of Lp(a) particles in the bloodstream.
With this information, clinicians can take informed steps to mitigate the risk of cardiovascular disease for their patients.
Last May, Roche’s Tina-quant Lp(a) RxDx assay received breakthrough device designation from the FDA. This assay is intended to aid in identifying individuals who may benefit from an emerging Lp(a)-reducing therapy.
"FDA grants 510(k) clearance to Roche’s Tina-quant molarity assay" was originally created and published by Medical Device Network, a GlobalData owned brand.
The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.