FDA Grants Breakthrough Device Designation to Blood Test Measuring Lp(a)

The US Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the Tina-quant® lipoprotein Lp(a) RxDx assay for evaluating lipoprotein (a) in a person’s bloodstream, an emerging key marker for hereditary cardiovascular risk.

Announced by Roche, in collaboration with Amgen, on May 22, 2024, the Tina-quant® Lp(a) assay is planned to be made available on the company’s installed base of more than 90,000 serum work area systems globally.

Pending FDA approval, the Tina-quant® will be made available to assist in selecting patients who could benefit from an innovative Lp(a)-lowering therapy.

“While modern lifestyles are a major driver, as much as 30% of mortality associated with cardiovascular disease occurs in individuals without modifiable risk factors,” Matt Sause, chief executive officer of Roche, said in a statement. “Lp(a) is a critical marker for people at risk of cardiovascular disease, but medicine has had limited solutions to adequately address the problem.”

Nearly one in five people globally experience elevated Lp(a) levels, which has been linked with a raised risk of cardiovascular diseases, such as myocardial infarction and stroke. Recent data from more than 16,000 patients in the Mass General Brigham Lp(a) Registry suggest elevated Lp(a) was associated with long-term risk of major adverse cardiovascular events, regardless of baseline atherosclerotic cardiovascular disease (ASCVD), in the database.

Another analysis of more than 50 studies with more than 100,000 participants indicated an elevated Lp(a) was associated with a greater risk of premature ASCVD. In particular, the data showed a more than 2-fold increase in the risk of a composite ASCVD outcome, as well as coronary artery disease (CAD) and peripheral artery disease (PAD).

A focused update to the 2019 National Lipid Association (NLA) Scientific Statement on the Use of Lp(a) in Clinical Practice identified sufficient evidence to support the recommendation to measure Lp(a) levels at least once in every adult for risk stratification.

The NLA statement indicated that Lp(a) levels represent a risk spectrum, not a threshold at a ‘dichotomous cutpoint.’ In particular, the Lp(a) risk categories are applicable across races and ethnicities, and high Lp(a) levels warrant early more intensive risk factor management.

However, in the news release, Jay Bradner, MD, executive vice president of Research and Development, and chief scientific officer at Amgen, noted Lp(a) testing rates remain ‘markedly’ low and typical lab tests may not consistently measure accurate Lp(a) levels.

“By combining Amgen’s deep legacy and expertise in cardiovascular disease with Roche’s diagnostic expertise, we can accelerate access to more standardized testing and equip more patients and healthcare providers with important information to better understand their risk for cardiovascular disease,” Bradner added.

References

1. _{Roche granted FDA Breakthrough Device Designation for blood test measuring Lp(a) – a key marker for hereditary cardiovascular risk. Roche. May 22, 2024. Accessed May 22, 2024. https://www.roche.com/media/releases/med-cor-2024-05-22.}
2. _{Tsimikas S, Marcovina SM. Ancestry, Lipoprotein(a), and Cardiovascular Risk Thresholds: JACC Review Topic of the Week. J Am Coll Cardiol. 2022;80(9):934-946. doi:10.1016/j.jacc.2022.06.019}
3. _{Campbell P. Elevated lp(a) levels linked to cardiovascular event risk, regardless of ASCVD history. HCP Live. March 4, 2024. Accessed May 22, 2024. https://www.hcplive.com/view/elevated-lpa-levels-linked-to-cardiovascular-event-risk-regardless-of-ascvd-history.}
4. _{Campbell P. Elevated lp(a) can predict premature ASCVD risk. HCP Live. May 14, 2024. Accessed May 22, 2024. https://www.hcplive.com/view/elevated-lp-a-can-predict-premature-ascvd-risk.}
5. _{Koschinsky ML, Bajaj A, Boffa MB, et al. A focused update to the 2019 NLA scientific statement on use of lipoprotein(a) in clinical practice. J Clin Lipidol. Published online March 29, 2024. doi:10.1016/j.jacl.2024.03.001}