Roche granted FDA Breakthrough Device Designation for blood test
measuring Lp(a) – a key marker for hereditary cardiovascular risk
- Approximately one in five
people worldwide have elevated Lp(a) levels, putting them at
increased risk of cardiovascular diseases including myocardial
infarction and stroke.1
- The Roche Diagnostics
Tina-quant® Lp(a) assay measures lipoprotein (a) in a person’s
bloodstream, and will be made available on Roche’s installed base
of over 90,000 serum work area (SWA) systems
worldwide.
- The test has been developed
in collaboration with Amgen.
Basel, 22 May 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY)
announced today that the Tina-quant® lipoprotein Lp(a) RxDx assay
has received Breakthrough Device Designation from the U.S. Food and
Drug Administration (FDA) to identify patients who may benefit from
innovative Lp(a)-lowering therapy currently in development. Lp(a)
is emerging as an important, yet under-recognised, potential risk
factor for cardiovascular disease, a major public health issue.
“While modern lifestyles are a major driver, as much as 30% of
mortality associated with cardiovascular disease occurs in
individuals without modifiable risk factors,2” said Matt
Sause, CEO of Roche Diagnostics. “Lp(a) is a critical marker for
people at risk of cardiovascular disease, but medicine has had
limited solutions to adequately address the problem. Through our
collaboration with Amgen, Roche is paving the way to make elevated
Lp(a) an actionable biomarker.”
"Lp(a) testing rates are markedly low, and existing lab tests
may not consistently and accurately measure Lp(a)
levels,3" said Jay Bradner, M.D., executive vice
president of Research and Development and chief scientific officer
at Amgen. "By combining Amgen’s deep legacy and expertise in
cardiovascular disease with Roche’s diagnostic expertise, we can
accelerate access to more standardised testing and equip more
patients and healthcare providers with important information to
better understand their risk for cardiovascular disease."
Once approved, the new Tina-quant® test is expected to be made
available to support the selection of patients who may benefit from
an innovative Lp(a)-lowering therapy.
About Lp(a)
Globally, as many as one in five people have elevated
Lp(a),1 where lifestyle interventions such as diet and
exercise have no significant impact. While Lp(a) levels can be
influenced by non-genetic factors including menopause, kidney and
liver disease and hyperthyroidism, they are predominantly (>90%)
determined by genetic variations in the LPA gene.4
Raised Lp(A) is particularly prevalent among women, and people of
African descent.5,6
High levels of Lp(a) have been shown to promote the buildup of
lipids in artery walls, leading to the development of plaques, and
have been associated with an increased risk of cardiovascular (CV)
events4. Lp(a) testing is therefore an important tool
for clinicians, enabling them to make a more accurate assessment of
CV risk, and it is expected to become a part of regular diagnostic
testing in the coming years.
Professional bodies around the world, including the National
Lipid Association, Canadian Cardiovascular Society, European
Atherosclerosis Society, European Society of Cardiology, and the
Beijing Heart Society have recommended that Lp(a) measurement
should be considered at least once in every adult person’s
life.
As Lp(a) has no single, defined molecular weight, there is a
consensus in the scientific community that, ideally, Lp(a) levels
should be measured in terms of the number of molecules per litre of
blood (nmol/L). This contrasts with widely available tests that
measure the molecular weight of Lp(a) in the blood (mg/L).
About Tina-quant® Lp(a) RxDx assay
The FDA has granted Breakthrough Device Designation to the Tina
quant Lp(a) RxDx assay for use in selecting patients with elevated
Lp(a) and a history of atherosclerotic disease for treatment with
an Lp(a) lowering drug. A lipoprotein (a) test involves a routine
blood draw during which a small sample of blood is used for
measurement. This test measures the number of Lp(a) molecules per
litre in a person’s bloodstream, which paves the way for Lp(a) to
serve as an actionable biomarker in future. If approved, it will be
available on selected cobas® platforms.
Currently, there is no FDA authorised Lp(a) assay measuring
Lp(a) in nmol/L available in the US. This assay will be part of
Roche’s wider portfolio of tests for cardiovascular diseases.
Together, these tests provide healthcare professionals the
opportunity to make informed decisions, allowing patients to access
new and innovative treatments.
About Breakthrough Device Designation
The Breakthrough Devices Program is a voluntary program for certain
medical devices that provide for more effective treatment or
diagnosis of a life-threatening or irreversibly debilitating
disease or condition. This program is designed to expedite the
development and review of these medical devices.
About Roche
Founded in 1896 in Basel, Switzerland, as one of the first
industrial manufacturers of branded medicines, Roche has grown into
the world’s largest biotechnology company and the global leader in
in-vitro diagnostics. The company pursues scientific excellence to
discover and develop medicines and diagnostics for improving and
saving the lives of people around the world. We are a pioneer in
personalised healthcare and want to further transform how
healthcare is delivered to have an even greater impact. To provide
the best care for each person we partner with many stakeholders and
combine our strengths in Diagnostics and Pharma with data insights
from the clinical practice.
In recognising our endeavour to pursue a long-term perspective
in all we do, Roche has been named one of the most sustainable
companies in the pharmaceuticals industry by the Dow Jones
Sustainability Indices for the fifteenth consecutive year. This
distinction also reflects our efforts to improve access to
healthcare together with local partners in every country we
work.
Genentech, in the United States, is a wholly owned member of the
Roche Group. Roche is the majority shareholder in Chugai
Pharmaceutical, Japan.
For more information, please visit www.roche.com.
All trademarks used or mentioned in this release are protected
by law.
References
[1] Tsimikas S and Marcovina S, Ancestry, Lipoprotein(a), and
Cardiovascular Risk Thresholds: JACC Review Topic of the
Week, J Am Coll Cardiol. 2022 Aug, 80 (9) 934–946
https://www.jacc.org/doi/full/10.1016/j.jacc.2022.06.019
[2] Beaglehole, R., Reddy, S., Leeder, S.R. (2007). Poverty and
human development: the global implications of cardiovascular
disease. Circulation 116, 1871–1873.
[3] Zheng W, Chilazi M, Park J, et al. Assessing the Accuracy of
Estimated Lipoprotein(a) Cholesterol and Lipoprotein(a)‐Free
Low‐Density Lipoprotein Cholesterol. Journal of the
American Heart Association. 2022;11(2). d oi:
10.1161/jaha.121.023136
[4] Kronenberg F. et al, Lipoprotein(a) in atherosclerotic
cardiovascular disease and aortic stenosis: a European
Atherosclerosis Society consensus statement, European Heart
Journal, Volume 43, Issue 39, 14 October 2022, Pages 3925–3946,
https://doi.org/10.1093/eurheartj/ehac361
[5] Simony SB, Mortensen MB, Langsted A, Afzal S, Kamstrup PR,
Nordestgaard BG. Sex differences of lipoprotein(a) levels and
associated risk of morbidity and mortality by age: The Copenhagen
General Population Study. Atherosclerosis. 2022 Aug;355:76-82. doi:
10.1016/j.atherosclerosis.2022.06.1023. Epub 2022 Jun 27. PMID:
35803767.
[6] Mehta A, Jain V, Saeed A, Saseen JJ, Gulati M, Ballantyne CM,
Virani SS. Lipoprotein(a) and ethnicities. Atherosclerosis. 2022
May;349:42-52. doi: 10.1016/j.atherosclerosis.2022.04.005. PMID:
35606075.
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