15 years ago, a senior Pharma executive claimed that medicines work in only 30 - 50% of patients. Since then, there has been an increasing focus on personalised medicines – therapies that are developed for specific patient populations where they will be the most beneficial. To do this requires better disease diagnosis and selection of the appropriate medicine. Companion diagnostics do just that.
A companion diagnostic (CDx) is a test or device which can determine whether a patient will benefit from a specific treatment. They are able to detect a specific biomarker in a patient sample, which in turn indicates whether a drug is likely to work and/or is safe for use in that patient.
Since the HER2 companion diagnostic was approved in 1998, to indicate whether the breast cancer drug Herceptin would be beneficial for individual patients, companion diagnostics have been used for screening, detection, prognosis of a disease, or for monitoring response to treatment.
Personalised cancer therapies
The vast majority of CDx are approved for oncology, allowing the identification of patient populations in which the drugs will be effective. Even though the number of patients receiving the treatment is reduced, these companion diagnostic-enabled drugs can still achieve multi-billion-dollar sales, giving them the name “niche busters”.
Unsurprisingly, there has been a surge in partnerships between pharma and diagnostics companies to develop companion diagnostics in oncology. Qiagen’s Partnering for Precision Diagnostics programme is proof of that. With ~25 programmes underway with leading pharmaceutical companies, Qiagen is enabling the development of diagnostics and therapies for lung, breast, colon and haematological cancers.
Matching patients with medicines
Last year, the FDA approved the first CDx to simultaneously screen tumour samples for biomarkers for 3 therapies for non-small cell lung cancer. The results of the Thermo Fisher Scientific device test are used to identify which treatment, or combination, is the most suitable for the patient. With this test, physicians can now match patients to these therapies in days rather than weeks by screening multiple biomarkers at once.
Diagnosis in hours, not days
BioMérieux’s BioFire leads the way in CDx panels – devices which screen for multiple disease-causing agents at the same time. In April, the BioFire pneumonia panel was submitted to the FDA for approval. The panel identifies 33 targets including 18 bacteria, 8 viruses and 7 antibiotic resistance genes. Other BioFire panels enable the rapid diagnosis of respiratory, gastrointestinal and meningitis/encephalitis infections. In each case, the system requires only two minutes of hands-on time and has a total run time of about 45 to 65 minutes, in contrast to clinical laboratory testing which can 2 – 3 days at best.
Treating bugs with the right drugs
Companion diagnostics are vital in antibiotic therapy. You have to treat the right bug with the right drug or it won’t work, and worse still if you use the wrong drug you increase the likelihood that resistance will develop. Currently, standard laboratory tests can take weeks to determine the cause of the infection, and whether the bacteria are resistant to any of the available drugs.
Oxford Nanopore is using its CDx DNA sequencing technology to rapidly identify the bacteria responsible for tuberculosis (TB) and the drug resistance profile during outbreaks in Madagascar. They have partnered with TB clinics in the country to evaluate the tests both in the lab and in the field. They aim to bring TB DNA sequencing closer to the patients for rapid diagnosis, to contain outbreaks and monitor drug resistance.
Truly personalised medicine
It is likely that cancer will remain the focus area for companion diagnostics. However, other therapeutic areas are emerging, including Alzheimer’s disease, arthritis, cystic fibrosis and human immunodeficiency virus (HIV).
Companion diagnostics will play a major part in identifying our predisposition to a disease, ensuring earlier disease diagnosis, and that the most appropriate therapies are prescribed to patients. Perhaps in 15 years’ time we will see medicines working in close to 100% of patients (rather than the current 50%), providing truly personalised medicine.
What does this mean for recruitment?
The current in demand roles are software developers, data scientists, engineers, project managers, clinical trial leads, quality assurance and regulatory affairs specialists. Business development roles are also on the increase. This is understandably given that, for medicines to really be personalised, drug and diagnostic companies need to be developing products in collaboration.
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