A middle-aged father of two is rushed to A&E with acute chest pain. Doctors suspect a heart attack, but they can only start treatment when they have a firm diagnosis – so speed is everything. He is given an electrocardiogram (ECG), which is used to diagnose some heart attacks, but not all. Fortunately, Roche has developed a sensitive blood test which can detect the presence of Troponin, a protein released into the bloodstream during a heart attack.  With the aid of this test, doctors were able to identify the patient as having a heart attack in
as little as an hour and start treatment.   

This is a great example of how an in vitro diagnostic test can support doctors in saving lives.

In vitro diagnostic tests are typically done on samples such as blood, urine or tissue taken from a human body. Many of these tests will be carried out in hospital laboratories or GP surgeries, but some tests can be done by patients themselves using hand-held devices – for example, to monitor coagulation of the blood.

 

Patient and doctor in consultation

In vitro diagnostic tests are used in around 70% of clinical decisions1 – they play an incredibly important (if often unsung) role in healthcare. Not only are they medically effective, they can also save the NHS money. Potentially, the earlier a disease is diagnosed, the easier it can be to treat. Ruling out a disease early in investigations can help to avoid unnecessary intervention or even costly hospitalisation. And identifying patients who will benefit from specific treatment eliminates ‘trial and error’, benefiting both the patient and the NHS.

Screening is particularly important in preventing disease – something Roche is committed to doing.  For example, cervical cancer is a highly preventable disease, yet over 3,000 women are diagnosed with it in the UK each year.2  More than 99% of cervical cancers are caused by a persistent, high-risk human papillomavirus (HPV) infection, which can be identified by testing for the presence of the HPV infection.Catching cervical cancer and treating early, in the pre-cancerous stage, can lead to better patient outcomes.

Our test for high-risk HPV infection found more cervical disease than traditional cytology.4

 

Accurately diagnosing disease

Over half a million people in the UK live with heart failure5 and because many of its symptoms (such as shortness of breath) can be attributed to other conditions, often it goes undiagnosed. Roche has developed a diagnostic test that measures the level of a protein (NT Pro-BNP) in a patient’s blood, to help diagnose heart failure, so doctors can start treating it. The test can also be used to monitor the course of the condition, helping doctors to adjust the treatment appropriately.6,7

 

Personalised treatment

Personalising treatment

Finding the right treatment for an illness can be difficult, as every patient is different; some will respond well to a drug, while for others the same drug might be ineffective. Diagnostic tests can help identify which patients are likely to respond to which drug. This is critical for their prognosis, reducing the guess-work so the right treatment can start immediately. And removing trial and error also has a big effect on the patient’s quality of life, as they don’t have to suffer unnecessary side-effects of treatments that can’t help them.

A great example of this is our test to identify the 1 in 5 breast cancer patients who have the HER-2 protein associated with aggressive cancer growth.8

Our suite of companion diagnostic tests helps treat people with breast, colorectal, lung and skin cancer.

Improving quality of life

Roche is committed to improving the lives of people living with a long-term medical condition. For example, people who have been diagnosed with atrial fibrillation can be given Warfarin to dramatically reduce their risk of stroke.9 However, it’s important that they monitor their blood clotting tendency (known as an INR ratio) to make sure it’s kept within a narrow range. Roche has developed hand-held devices which patients can use to monitor themselves, giving instant feedback so they can make adjustments where necessary. It’s been shown that people using these devices are much more likely to keep their INR ratio within their therapeutic range than those who attend monthly clinics.10

 

References

  1. Rohr U-P, Binder C, Dieterie T, et al.  The Value of In Vitro Diagnostic Testing in Medical Practice: A Status Report, PLOS ONE 2016, 11(4): e0154008
  2. Cancer Research UK (https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/cervical-cancer) last accessed september 2018
  3. CDC, Epidemiology and Prevention of Vaccine-Preventable Diseases – HPV (https://www.cdc.gov/vaccines/pubs/pinkbook/index.html) last accessed September 2018
  4. Wright CW et al. Primary cervical cancer screening with human papillomavirus: end of study results from the ATHENA study using HPV as the first-line screening test. Gynacol Oncol 2015; 136(2):189-97  
  5. British Heart Foundation (https://www.bhf.org.uk/heart-health/conditions/heart-failure) last accessed September 2018
  6. Januzzi JL, Throughton R (2013) Are Serial BNP Measurements Useful in Heart Failure Management? Serial Natriuretic Peptide Measurements are useful in Heart Failure Management.  Circulation: 127:500-508
  7. Zile MR, et al (2016) Prognostic Implications of changes in N-Terminal Pro-B-Type Natriuretic Peptide in Patients With Heart Failure. J Am Coll Cardio;68:2425-2436
  8. Fabi, A et al.  First-line therapy in HER-2 positive metastatic breast cancer: is the mosaic fully completed or are we missing additional pieces?  Journal of Experimental and Clinical Cancer Research CR35(2016): 104
  9. Hart RG et al. Meta-analysis: Antithrombotic Therapy to Prevent Stroke in Patients Who Have Nonvalvular Atrial Fibrillation. Ann intern Med 2007; 146:857-867.
  10. Heneghan C. et al. Lancet 2012; 379:322-334

 

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Date of preparation: October 2018