* 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) events(4). 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 (http://www.roche.com).
All trademarks used or mentioned in this release are protected by law.
References
(1) Tsimikas (https://www.jacc.org/doi/full/10.1016/j.jacc.2022.06.019) S and
Marcovina (https://www.jacc.org/doi/full/10.1016/j.jacc.2022.06.019) S,
Ancestry, Lipoprotein(a), and Cardiovascular Risk Thresholds: JACC Review Topic
of the Week, J Am Coll Cardiol (https://www.jacc.org/journal/jacc). 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.
Roche Global Media Relations
Phone: +41 61 688 8888 / e-mail: media.relations@roche.com
(mailto:media.relations@roche.com)

  Hans Trees, PhD           Sileia Urech
  Phone: +41 79 407 72 58   Phone: +41 79 935 81 48
  Nathalie Altermatt        Simon Goldsborough
  Phone: +41 79 771 05 25   Phone: +44 797 32 72 915
  Karsten Kleine            Nina Mählitz
  Phone: +41 79 461 86 83   Phone: +41 79 327 54 74
  Kirti Pandey              Yvette Petillon
  Phone: +49 172 6367262    Phone: +41 79 961 92 50
  Dr. Rebekka Schnell
  Phone: +41 79 205 27 03

Roche Investor Relations

 Dr. Bruno Eschli                        Dr. Sabine Borngräber
 Phone: +41 61 68-75284                  Phone: +41 61 68-88027
 e-mail: bruno.eschli@roche.com          e-mail: sabine.borngraeber@roche.com
 (mailto:bruno.eschli@roche.com)         (mailto:sabine.borngraeber@roche.com)
                                          (mailto:sabine.borngraeber@roche.com)

Dr. Birgit Masjost
Phone: +41 61 68-84814
e-mail: birgit.masjost@roche.com
(mailto:birgit.masjost@roche.com)
Investor Relations North America

  Loren Kalm
  Phone: +1 650 225 3217
  e-mail: kalm.loren@gene.com (mailto:kalm.loren@gene.com)

Â