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Survey Finds Pharma Needs to Strategically Engage EU Labs when Launching Personalized Rx Products

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By Turna Ray

A survey of laboratories located in five European Union countries shows that pharmaceutical companies aren't strategically engaging labs when launching companion diagnostics that support their personalized treatments.

Labceutics, a subsidiary of personalized medicine-focused consultancy Diaceutics, polled 31 labs in Spain, Italy, Germany, France, and the UK between September and December of 2011 in an effort to identify the barriers the industry faces when adopting new companion tests.

The survey, conducted by Delphi, revealed that "pharma has forgotten laboratories are a critical stakeholder" in commercializing their personalized drugs, Labceutics said.

Among surveyed labs, 64.5 percent said that the most frequent way they find out about a new test is that the lab manager reads about it in a publication; 16.1 percent hear about new tests most readily from doctors; and 12.9 percent said they learn of new tests in some other way. Only 6.5 percent of labs polled said they were contacted directly by a drug company about a new companion test.

Pharma's failure to engage labs when launching drug/test combination treatments could significantly impact the market success of these products, since there are around 14,000 labs across Europe that operate in a decentralized fashion, according to the consultancy.

"In order to truly enhance the power of companion diagnostics, their access and adoption by prescriptors, highest quality '[personalized medicine] aware' integrated laboratory networks are crucial," Labceutics said in an abstract presented at the Targeted Anticancer Therapies meeting in Amsterdam last week, discussing some of the Delphi survey data.

In the US, personalized treatments that are approved by the Food and Drug Administration and paired with agency-cleared diagnostic test kits can be performed at multiple labs. However, labs performing these tests have to meet national and state certifications.

Incomparison, lab regulation in the EU is fragmented and most genetic tests are exempt from pre-market evaluation. In this regulatory environment there isn't a lot of pressure on labs to adopt in vitro diagnosticss accompanying personalized drugs.

Of the labs Labceutics surveyed, approximately 40 percent had never purchased an IVD kit and only around 25 percent said they prefer to use IVD kits purchased from a diagnostic company to begin a new testing service. Meanwhile, 75 percent of the labs said that since so many companion tests are performed at low volumes in the initial years of market launch, they review each test's business case before deciding on whether to implement an IVD or a laboratory-developed test.

Given this uncertainty, pharmaceutical firms looking to commercialize molecularly targeted treatments in the EU should consider how to engage this industry instead of betting that labs will adopt IVD kits, according to Labceutics.

For example, Pfizer is working with Abbott Molecular to develop and commercialize a companion ALK mutation IVD for its non-small cell lung cancer drug Xalkori. The drug hasn't yet been approved by the European Medicines Agency. If it is, the drug's adoption in EU countries may be slowed if Pfizer doesn't strategically engage labs.

In three out of the five countries covered in the survey, labs were performing ALK mutation testing at lower rates than more established PGx tests, such as those that gauge KRAS and EGFR mutations.

However, all UK labs polled said they preferred to develop their own LDTs rather than implement a CE-marketed IVD kit and indicated they are performing ALK mutation testing at similar rates as KRAS and EGFR tests.

In fact, Lab21, a UK-based clinical lab services and diagnostics company, recently began offering testing services to help physicians determine which of their NSCLC patients harbor EML4-ALK translocations and are more likely to respond to ALK inhibitors, such as Xalkori (PGx Reporter 2/22/2012).

Even in this situation, it "behooves Pfizer to be talking to [UK] labs" when it comes time to commercialize a companion test for Xalkori, Diaceutics CEO Peter Keeling told PGx Reporter in a recent interview (PGx Reporter 2/22/2012).

Diaceutics launched its laboratory network service for the European market last year. Labceutics aims to help pharma and diagnostics companies gain access to Europe's lab market and figure out how to use this untapped network to deliver tests to physicians and patients seeking to personalize treatments.

Labceutics is planning to publish the data from its laboratory survey in the coming months and has shared the information with more than 100 of its lab network partners.


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