Advancing patient outcomes in personalized care
As a company, Roche empowers healthcare professionals to optimize care and improve outcomes for their patients. Increasing predictability and reliability measures that help reduce risks to patients and costs to the healthcare system are at the forefront of Roche’s commitment to meet the changing demands in diagnostic testing. Innovation is the foundation of our business strategy and we are continually working to create integrated solutions that enable swift and clinically-validated decision making across a variety of healthcare settings.
“Throughout our business, whether it’s women’s health, cardiology or neurology, we strive to ensure high-quality results by providing best-in-class diagnostics solutions to make a difference to people’s lives“
Transforming Women’s Health
Roche’s continued innovation in diagnostic solutions for a wide range of diseases, including oncology, maternal care and infectious diseases, makes a significant difference to millions of women, and their families worldwide.
Fertility issues affect 1 in 10 couples globally1 and Roche has responded to this need by developing advanced screening and diagnostic tests to empower couples and clinicians to make decisions, through pregnancy planning to birth. The Elecsys® AMH Plus immunoassay and the pre-eclampsia test are two examples of this.
Early intervention, especially when accompanied by a comprehensive range of accurate tests, can make a significant difference to a couple’s chances of conception.
- The Elecsys® AMH Plus immunoassay is the first companion diagnostic to be approved for use in fertility. Anti-Mullerian hormone (AMH) testing involves a simple blood test that delivers results during consultation in 18 minutes from loading the serum sample.2-7
- The AMH test has advantages over similar tests since it can be tested at any time during the menstrual cycle, whereas other assays need to be tested on a specific day. This simple fertility blood test delivers results during consultation, helping clinicians incorporate AMH testing into routine patient management.
New screening, diagnostic and prognostic tests from Roche Diagnostics deliver highly targeted, accurate and reliable measures for women from pregnancy planning to screening for issues during gestation and right through birth.
Results from the PROGNOSIS study published in the New England Journal of Medicine earlier in January 2016, showed how a new blood test can be used as a predictive tool for preeclampsia.8 This simple test enables healthcare professionals to avoid unnecessary hospitalizations by reliably ruling out preeclampsia, as well as improving outcomes for mother and child by ruling in preeclampsia and allowing optimized prenatal care.
Revolutionizing cardiac diagnosis and management
Cardiovascular disease continues to be a leading cause of death globally and with associated cost and care requirements rising9, heart failure (HF) continues to be a major burden on the healthcare system. Optimal risk stratification to allow cost-effective treatment is a healthcare priority. Recent efforts have concentrated on the use of biomarkers reflecting different pathophysiological processes and in predicting outcomes. NT-proBNP is an established prognostic marker that is revolutionizing the diagnosis and management of heart failure and is now regarded as the gold standard biomarker in this condition.10
“Cardiac diagnosis and management needs to be managed across a number of stages in the patient’s journey, and Roche provides support across these settings. The use of biomarkers, including high-sensitivity Troponin T and NT-proBNP is widely recommended both for diagnosis and prognosis in heart failure. “
Angiotensin receptor-neprilysin inhibitor (ARNi) drugs are increasingly being adopted as part of standard treatment for heart failure,11-12 and Roche’s NT-proBNP testing is therefore becoming increasingly essential for laboratorians to give the right results to physicians, regardless of which therapy the patient is taking.
GDF-15 is a new biomarker to aid in the risk stratification and treatment of patients with cardiac conditions such as Heart Failure and Acute Coronary Syndrome. This new marker will provide physicians considerable additional insight into a patient's changing complete risk profile beyond established cardiac markers, and provides improved insight into which patients are at higher risk, and need to be more closely monitored and treated. The launch of the Elecsys GDF-15 assay demonstrates Roche’s commitment to develop innovative biomarkers to support clinical decision making to further improve patient management and improve lives.
Early intervention in Alzheimer’s
Roche is developing reliable diagnostics that can enable earlier Alzheimer’s disease detection, supporting earlier intervention. Roche collaborates with leading pharmaceutical companies to address the significant unmet need in this field. As a company we aim to improve the standard of care by providing a meaningful range of clinically effective – and routine – diagnostic tools in anticipation of disease modifying therapies becoming available.
A number of tools are in development to support Alzheimer’s disease diagnosis and three Elecsys® assays; Amyloid beta1-42, Total-Tau and Phospho-Tau for cerebral spinal fluid (CSF) detection are in late stage development. We are also actively assessing further blood-based and cerebrospinal fluid-based biomarkers that could allow differential diagnosis, monitoring and better understanding of the disease.
Commitment to clinical evidence
In addition to developing innovative, novel products, as a company, Roche continually invests in medical value and clinical evidence, putting patient care center stage.
The TRAPID-AMI study is one example – evaluating whether chest pain patients can be safely excluded from a diagnosis of myocardial infarction (also termed rule-out) with the Troponin T high sensitive assay after just an hour, instead of a previous duration of 3 to 6 hours.13-14 Historically, algorithms for myocardial infarction have required time spans of 3 to 6 hours. Today, advances in technology and a commitment to urgent care have enabled Roche to be the first company to develop and launch a highly sensitive troponin assay for routine clinical use. This trial benefits patients and takes pressure off emergency departments, enabling rapid transfer to specialized treatment or early discharge (TRAPID-AMI study).
Roche’s Elecsys® Troponin T high sensitive test helps enable earlier detection of an acute myocardial infarction (AMI) and an earlier rule-out and rule-in of AMI due to higher sensitivity and better analytical precision.
By doing now what patients need next, we continue to fulfil our commitment of providing high quality, integrated and simplified diagnostic tests to enhance healthcare provision and make a difference to patients’ lives.
1. Boivin J, et al. International estimates of infertility prevalence and treatment-seeking: potential need and demand for infertility medical care. Hum Reprod. 2007; 22(6): 1506-12.
2. Roche Diagnostics. Elecsys® AMH (anti-Mullerian hormone) Plus immunoassay: Method sheet. 2016. Available at: https://pim-eservices.roche.com. Last accessed: January 2017.
3. Deeks ED. Elecsys® AMH assay: a review in anti-Müllerian hormone quantification and assessment of ovarian reserve. Mol Diagn Ther. 2015; 19: 245-249.
4. Gassner D, Jung R. (2014) First fully automated immunoassay for anti-Müllerian hormone. Clin Chem Lab Med 52(8),1143-52.
5. Anderson RA, et al. (2015) Prospective study into the value of the automated Elecsys antimüllerian hormone assay for the assessment of the ovarian growing follicle pool. Fertil Steril 103(4), 1074–80.e4.
6. Nelson SM, et al. (2015) Two new automated, compared with two enzyme-linked immunosorbent antimüllerian hormone assays. Fertil Steril, 104(4), 1016-1021.e6.
7. Hyldgaard J, et al. (2015) Comparison of two different methods for measuring anti-mullerian hormone in a clinical series. Reprod Biol Endocrinol 13(1),107.
8. Zeisler H, et al. (2016) Predictive value of the sFlt-1:P1GF ratio in women with suspected preeclampsia. New Engl J Med 374, 13-22.
9. World Health Organization. Cardiovascular Diseases (CVDs). Available at: http://www.who.int/mediacentre/factsheets/fs317/en/ Last accessed: June 2017.
10. McKie PM, et al. (2016) NT-proBNP: The gold standard biomarker in heart failure. J Am Coll Cardiol 68(22), 2437-2439.
11. Ponikowski P, et al. (2016) 2016 ESC guidelines for the diagnosis and treatment of acute and chronic heart failure. Ero J Heart Fail 18(8):891-975.
12. Yancy CW, et al. (2017). 2017 ACC/AHA.HFSA focused update of the 2013 ACCF/AHA Guideline for the management of heart failure. Circulation [Epub ahead of print].
13. Reichlin, T et al. (2012) One hour rule-out and rule-in of acute myocardial infarction using high-sensitivity cardiac troponin T. Arch Intern Med 172(16), 1211-18.
14. Mueller C, et al. (2016) Multicenter evaluation of a 0-hour/1-hour algorithm in the diagnosis of myocardial infarction with high-sensitivity cardiac troponin T. Ann Emerg Med 68(1), 76-87.