June 2016 - If breakthrough will not break through

At the J.P. Morgan Health Care Conference in January this year, liquid biopsies were mentioned as „a revolutionary blood test that can detect cancer” [1]. Currently, local media (such as Handelsblatt[2]) mention this method having a breakthrough character.

 

Advances in genetic science enable researchers to detect genetic mutations of cancers. Unique mutations of patient’s blood can give experts a sign of the presence of cancer. These DNA mutations can be found in cells or they are floating freely in the bloodstream. Liquid biopsies - unlike traditional biopsies involving invasive surgery - therefore rely on an ordinary blood draw.

 

This might lead to early detection of different types of cancer before the formation of metastases. U.S. market potential for the liquid biopsy is projected to reach more than $20 billion a year. Therefore several Venture Capital companies invest tens of millions into companies working on the method of liquid biopsies. In fact, the method is already applied on a limited basis in the US, though mainly in patients with Stage 3 or Stage 4 cancers to help determine how well treatment is working.

 

So far so good. There is no doubt that there is an urgency to detect cancer at an early state and at much faster speed than traditional methods. In addition, those tests have to be at a reasonable level of costs for the health care systems. If not, they might be limited only to research and / or to a restricted population being able to come up for the immense cost of this kind of diagnostic method.

 

Knowing that liquid biopsies do have the potential to detect cancer at early stage, this first need is almost fulfilled. So far there is still one big hurdle to take: the test owns a relatively high failure rate. That means that only 80% of existing advanced cancer patients and only 47% localized cancers out of a population of more than 840 patients could be detected.

 

Talking about speed, the breakthrough character might already loose a bit of its weight. Today, common biopsies require a few days up to a month, strongly dependent in which Country it is performed. The liquid biopsies last an average of 12 days until their result can be communicated. It is therefore not clear whether the second need can be fulfilled or not. Considering the need for a reasonable cost level per test, the “breakthrough method” definitely fails. Today’s costs per test are communicated to be at $5’400 per test. The costs might be even higher. Due to the high failure rate of the method, repeated testing is required. To work statistically, a minimum of a triple is required. The minimum costs per test are then $ 16’200.

 

In the US, some insurance companies plan picking up a portion of that. The rest is to be paid by the patient. In the EU, the European Partnership for Action Against Cancer (EPAAC[3]) formulates the need for a public screening of more than 500 million probands until 2020. The EU therefore decided to support the reimbursement for preventive cancer screening.

 

Doing a fast and easy to run calculation it becomes clear that offering such a “breakthrough method” either for screening or routine testing of treatment acceptance cannot be paid by any health care system. This would even be true if the cost per test could be reduced to 1/10 of today’s costs.

 

Therefore, the need for a pre-screening or low-cost high-throughput diagnostic method, such as it is the vision of 4D Lifetec, is once more deeply verified.

 

[1]  http://www.cnbc.com/2016/01/11/a-revolutionary-blood-test-that-can-detect-cancer.html

[2]  http://www.handelsblatt.com/technik/medizin/qiagen-setzt-auf-fluessigbiopsie-krebs-erkennen-mit-nur-einem-tropfen-blut/13684958.html

[3]  http://ec.europa.eu/transparency/regdoc/rep/1/2014/DE/1-2014-584-DE-F1-1.Pdf