Liquid biopsies set to transform cancer care

A new generation of faster, more accurate diagnostics is set to transform cancer care over the next decade.

A new generation of ‘liquid biopsy’ tests which allow cancer to be detected far earlier, and help doctors tailor treatment to existing cancer patients, is set to transform cancer care.

One of the biggest obstacles to catching cancer earlier is the need for tissue samples, or biopsies, to be taken from patients with a suspected tumour; these can take weeks to arrange and process, and can sometimes be inconclusive or inaccurate.

Now a wave of new liquid biopsy tests is in development, and will be able to give far faster and more accurate results from a simple blood or urine test.

One company working in the cutting-edge field is MdxHealth, which is developing a liquid biopsy for bladder cancer. Its technology works by tracking biomarkers of bladder cancer DNA methylation in the urine.

The test is designed to rule out bladder cancer in patients with haematuria (blood in urine) non-invasively. Current diagnostic tools are invasive and only have a 70 per cent sensitivity rate, which means many patients are at risk of having undetected cancer.

MdxHealth announced preliminary data from a study of 154 patients with haematuria on Tuesday. These showed that its epigenetic liquid biopsy was able to rule out bladder cancer, with a negative predictive value (NPV) of 98.3 per cent in the group.

The test is based on a combination of MDxHealth and University Erasmus Medical Centre (‘Erasmus MC’) bladder cancer DNA methylation biomarkers. The partners have now signed an exclusive worldwide biomarker licence and scientific collaboration agreement with MDxHealth to have worldwide rights for the use of the biomarker technology for lab-developed tests as well as in vitro diagnostic (IVD) products.

Liquid biomarkers have potential to help detect cancers much earlier, giving patients a far better chance of survival and saving healthcare system millions by reducing the need for surgery, radiotherapy and drug treatment.

However the tests won’t come cheap. Another company, Guardant, has had its Guardant360 liquid biopsy on the US market since June 2014 as a lab-developed test. It is being used to identify which mutations are driving the cancer in patients already being treated for cancer. Its US price is $5,400 and is covered by some insurance firms for certain cancers.

Diagnostics firms can argue that the liquid tests are cheaper than traditional biopsies, and will save lots of money in preventing the need for expensive drug treatment.

 

“Liquid biopsies are also part of the ‘personalised medicine’ revolution”

 

 

Liquid biopsies are also part of the ‘personalised medicine’ revolution, which includes the profiling of a patient’s genes and their disease (such as cancer) and the use of medicines which target certain genetic mutations.

Diagnostics are a vital part of this new approach and liquid biopsies, like Guardant’s, can screen out those patients who won’t benefit from certain targeted cancer therapies, also saving on wasted treatment and expenditure.

A number of companies are now gearing up to launch new products over the next few years, including Qiagen, Biocept, Genomic Health and RainDance Technologies.

Trovagene is another company working on a urine-based test, which, if they prove reliable, represent an even simpler and potentially cheaper way of diagnosing cancer and other diseases earlier.

These new technologies will require health systems to adapt rapidly as well. The UK government has just unveiled plans to accelerate these changes, funding six centres to spearhead the development of new molecular pathology tests. This includes liquid biopsies for cancer, but also the development of biomarkers for a range of other diseases.

A report by analysts at Cowen & Co earlier this year said annual sales for liquid biopsies could exceed $10 billion, which would make the diagnostics firms major players in a new world of personalised healthcare.

Roche is unusual among major pharma firms in having a diagnostics division alongside its cancer drug business, with the vision of creating integrated oncology services to healthcare professionals and patients. In April this year the company entered the liquid biopsy market by buying Palo Alto firm CAPP Medical, and also acquired Cambridge, Mass based Foundation Medicine, which markets a cancer genomic profiling assay.

Other pharma companies will need to think about their own long-term strategies as the diagnostics revolution gathers pace. The ‘disruptive’ potential of this innovation is likely to have a major impact on pharma and how its products are used.

About the author:

Andrew McConaghie is pharmaphorum’s Managing Editor, Feature Media.

Andrew can be contacted via: andrew@pharmaphorum.com

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