The US Food and Drug Administration has granted breakthrough device designation to the Tina-quant Lp(a) RxDx assay, a blood test developed by Roche in collaboration with Amgen. This test measures lipoprotein(a) [Lp(a)] levels to identify adults who may benefit from emerging lipid-lowering therapies.
Lp(a) is a genetically inherited lipoprotein linked to higher risks of heart disease, stroke, and other vascular conditions. Approximately 20% of people globally have elevated Lp(a) levels, which are not significantly influenced by lifestyle changes such as diet and exercise. High Lp(a) levels are especially common among women and individuals of African descent.
Roche highlighted the importance of Lp(a) testing for clinicians, noting its potential to enhance cardiovascular risk assessment and its likely inclusion in routine diagnostic testing in the future. Upon approval, the Tina-quant Lp(a) RxDx assay will be available on select Roche cobas platforms.
Although low-density lipoprotein (LDL) cholesterol is more prevalent and carries significant heart disease risk, Lp(a) particles pose a risk approximately six times higher per particle, according to a recent study. Currently, there are no approved pharmacologic treatments for lowering Lp(a) levels in the US, but several are in development.
One promising candidate is zerlasiran, a short interfering RNA (siRNA) therapy by Silence Therapeutics. Zerlasiran works by temporarily blocking the LPA gene, reducing the production of apolipoprotein A, a key component in Lp(a) synthesis. Phase 1 and Phase 2 trials have shown significant and sustained reductions in Lp(a) levels with zerlasiran.
As reported by Medscape, other siRNA therapies aiming to lower Lp(a) include pelacarsen, lepodisiran, olpasiran, and muvalaplin. These developments represent significant strides in targeting elevated Lp(a) levels and improving cardiovascular outcomes.