AstraZeneca to collaborate on DNA diagnostics for cancer

AstraZeneca is to collaborate on two new diagnostics which would allow doctors to screen for lung cancer simply by analysing a patient’s blood.

The new collaborations, one with Roche and one with Qiagen, would allow doctors to bypass the current need for a tissue sample from a tumour biopsy to determine what kind of tumour the patient has.

AstraZeneca is working with Qiagen to develop a circulating tumour DNA (ctDNA) test to identify non-small cell lung cancer (NSCLC) patients whose tumours are EGFR mutation positive, and who may be suitable for treatment with Iressa. Meanwhile the firm has teamed up with Roche’s diagnostics division on a test to be used with its pipeline NSCLC drug, AZD9291.

Both Iressa and AZD9291 target only EGFR positive patients, and therefore need swift and accurate diagnostics to help identify which patients would benefit from the targeted therapies.

There are numerous problems with existing biopsy route for determining tumour type. One is that it is not possible to obtain a biopsy sample in up to 20% of advanced NSCLC patients, for example due to the site of the tumour or the individual being too unwell to have a biopsy taken via surgery. This means these patients may currently miss out on receiving any targeted therapies for their disease.

AstraZeneca says the blood-based tests represent an important step forward in personalised healthcare: the tests will allow AstraZeneca’s drugs to reach more patients, making a crucial difference to their value to patients and doctors, and potentially also transforming their commercial value.

Roche’s Tarceva is currently the market leader in the NSCLC market, but AstraZeneca want to challenge this dominance by reinvigorating its presence in the field.

Qiagen has already established itself as one of the front runners in so-called companion diagnostics, already having three FDA approvals: Its therascreen KRAS is used alongside Amgen’s Vectibix as well as Merck Serono and Lilly’s Erbitux, while its existing EGFR test is approved for use with Boehringer Ingelheim’s NSCLC treatment Gilotrif.

Roche launched its own EGFR diagnostic for use with its NSCLC drug Tarceva in 2013, but this and Qiagen’s diagnostics all require tissue samples.

Ruth March, vice president, Personalised Healthcare and Biomarkers at AstraZeneca, said: “Our bold ambition is to transform patients’ lives through personalised healthcare, ensuring that innovative treatments are matched to those patients who will benefit most. Diagnostic tests are an integral part of delivering effective personalised healthcare. By combining our skills with those of diagnostic partners like Roche and Qiagen, we can push scientific boundaries to pioneer and develop a broad range of companion diagnostics across our therapy areas, in order to deliver the most effective, life-changing medicines to patients.”

An exciting future for personalised medicine – but who will pay for the tests?

The potential of ctDNA testing is huge, and the technology could be used to screen for a broad range of mutations, allowing doctors to rapidly identify specific tumour sub-types and prescribe targeted therapies. The blood-based tests could also be used monitor disease progression.

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