Diaceutics PLC, (AIM: DXRX), a provider of diagnostic data analytics and implementation services to the global pharmaceutical industry, announces new research which shows that half of eligible cancer patients may be missing out on tests for potentially life-saving precision medicines. The findings are published in the 2019 Diaceutics Pharma Precision Medicine (“PM”) Readiness Report.
Precision medicine drugs are tailored to patients expressing specific molecular or genetic biomarkers, which are identified with a diagnostic test. At the end of 2018 there were 173 FDA-approved precision medicine drugs on the market, and it is estimated that more than 100 will be approved in the next three years for oncology alone.
Despite advances in precision medicine and the continuous discovery of transformative biomarkers and biomarker combinations that can identify new treatable patient groups, Diaceutics’ report uncovers a highly fragmented precision testing ecosystem. It found that the average oncology precision medicine therapy is launched some 4.5 years before an accompanying diagnostic test is readily accessible by all patients, resulting in a significant proportion of the eligible patient population missing out on precision medicine therapies.
A chief reason for this, according to Diaceutics’ findings, is the near-monopolisation of Pharma’s precision testing pre-launch investment by a few diagnostic technology supply companies, diverting focus away from the investment needs of laboratories and other diagnostic providers on the front line.
The research found that as of 2019, the oncology revenues of 54 precision therapies rest upon the shoulders of six diagnostic companies. This, the report states, is resulting in slow laboratory test adoption, minimal support for the introduction of new precision tests in laboratories, inadequate biomarker education for physicians and lengthy lag times between the publication of guidelines recommending a new therapy and guidelines recommending the associated diagnostic test.
Furthermore, the Pharma PM Readiness Report found that in an effort to improve the success and human impact of new precision medicine drugs, laboratories are moving to bridge the gap between themselves and Pharma. The Company found that following the launch of a treatment, they are bypassing diagnostic technology supply companies entirely and developing equally effective biomarker tests themselves. Some 74% of all oncology precision testing in the US – and more elsewhere in the world – is now carried out with tests developed by laboratories, most without Pharma support.
Peter Keeling, CEO and founder, Diaceutics, said: “It is mind-blowing that cutting edge treatments aren’t reaching the patients they are intended for because of problems in the testing ecosystem, which in a large part is being exacerbated by the monopolisation of essential investment needed in the post-launch testing ecosystem. Monopolisation in any industry is risky and reduces competition. But in the case of precision medicine, the risk is loss of patient lives.
“Today’s diagnostic companies generate revenues by developing new tests to meet Pharma’s regulatory needs. Their profits therefore no longer rely on the long-term success of precision medicine therapies, so the seamless integration of patient testing into new therapy launches is not of value to them. In contrast, for Pharma, there is enormous value in improving the daily function of the testing ecosystem. Our own research shows that for every dollar invested by Pharma in appropriate and timely diagnostic commercialisation, the return is $30-$60 in additional therapy revenue. This, in turn, results in more patients getting tested, which is good news for labs, too.
“What we are seeing is the democratisation of the testing ecosystem by laboratories – something that we in Diaceutics welcome but believe can be accelerated and improved with better coordination between all the stakeholders. Diaceutics was founded on a mission to connect the dots in the precision medicine ecosystem and we are working with laboratories and pharmaceutical companies to ensure more patients get access to better treatment at the right time.”
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