Originally published Oct. 3.
NEW YORK (GenomeWeb) – In a deal with drugmaker GlaxoSmithKline, Clarient Diagnostics Services will set up a global laboratory network aiming to standardize genetic testing services so that patients can better access personalized drugs or enter clinical trials for investigational therapies.
According to Clarient CEO Cindy Collins, the GE Healthcare subsidiary was approached by GSK to establish the lab network, which will be a subscription-based service that other healthcare groups and pharmaceutical firms will be able to take advantage of. "GSK recognized the need to improve the consistency, access, and the quality of companion diagnostic testing throughout the world," Collins told PGx Reporter. "They came to us some time ago and really felt that jointly we could develop a network of laboratories for GSK, and for all pharma for that matter, that would have that consistency and quality standardization."
When it comes to molecularly guided personalized drugs, only patients with a certain biomarker profile can benefit from the treatments. Most drug developers by now fully appreciate that limited access to diagnostics that gauge these biomarkers also hinders the drugs reaching patients who are likely to benefit. This is a concern particularly among pharmas who sell their products on a global scale, in countries where the lab industry comprises many small shops with varying procedures.
"In many markets around the world, availability to high-quality diagnostic testing is limited for many reasons, such as lack of a coordinated logistical system, limited IT communication tools, and unstandardized techniques, which creates variability," Jonathan Pan, GSK's head of oncology companion diagnostics and disease strategy, told PGx Reporter.
Collins noted that drug companies are often interested in GE/Clarient's ability to provide companion diagnostic testing for their personalized drugs in multiple countries, and so she anticipates that other pharmas will also be interested in utilizing this genetic testing lab network once it's set up. In establishing this network, GE will approach existing labs in different countries that operate with a certain kind of infrastructure and level of performance, Collins explained. Then GE will put in place testing equipment and reagents, and train lab personnel on the system and monitor the lab's performance.
The first assay that Clarient will set up at these labs is a 70-gene mutation panel. Initially, testing efforts will be focused on markers associated with melanoma, particularly BRAF V600E and V600K mutations. Eventually, the lab network will branch out to analyzing mutations important for other types of cancers.
This will help GSK grow the global market for its melanoma drugs in patients with BRAF mutated tumors. In May 2013, GSK received US regulatory approval for Tafinlar (dabrafenib) and Mekinist (trametinib) as monotherapies that treat melanoma patients with BRAF V600E or V600K mutations whose tumors have spread and can't be operated on. Then, in January of this year, the US Food and Drug Administration granted accelerated approval to the Mekinist/Tafinlar combination as an option for advanced BRAF-mutated melanoma patients.
With the original approval of these drugs last year, the agency also approved BioMérieux's THxID BRAF Kit as a companion diagnostic that doctors can use to identify which melanoma patients have these mutations and therefore will respond to treatment. "In the US, for the work that we do with pharma companies we use FDA-cleared companion tests," Collins said, noting that the aim of this collaboration is really to standardize genetic testing in developing markets outside the US.
GE is planning to launch four labs in the first quarter of 2015, starting with Russia and Brazil, where GSK determined there is an unmet need for standardized genetic testing services to direct precision therapies. "Because of the increase in the number of precision medicines, we are looking to advance the current model of one drug and one test in markets where even that paradigm is not available," Pan said, noting that BioMérieux's BRAF kit will continue to be marketed in the US and other markets where it is available.
Another aspect of the collaboration will be the development of a database, for which GE/Clarient plans to collect and store data, such as the patient's age, gender, prescribed treatments, and the results of the 70-mutation panel test. This information will be available to drug developers and other research organizations on a subscription basis.
There are marked differences in mutation prevalence across geographies and even in populations within a single country. As such, firms developing a drug targeted to a rarely occurring cancer mutation, for example, could use the GE/Clarient database to get a snapshot of the prevalence of this marker on a global scale or in a particular country to inform their development strategy. "We will partner with GSK to make that data available to … other parties that have an interest in analyzing that data for population health [research], geospatial considerations, or other purposes," Collins said.
National biological data collection regulations could limit the types of data subscribers can access from a particular region, however. "Anything we do, of course, would be in compliance with each and every country we work with in terms of what [patient] information is allowed to be used," Collins noted. "In general, we believe we will be able to aggregate most of the data, but it could vary."
With the growing availability of molecularly guided therapies and the recognized challenges in access to standardized lab testing, other pharmas will be interested in accessing these services, GSK and GE/Clarient expect. "We envision other pharma companies would likely … come to us in countries where we have established a GE/Clarient laboratory to perform their testing in a lab where GE trained personnel and validated [the tests] and has oversight of the quality of testing coming out of that lab," Collins said. "Both GSK and GE are very open to working with other pharma partners."
Historically, pharmaceutical firms haven't had to worry about how diagnostics would impact the sales of their products. And so, just a few years ago, the problem of lab standardization wasn't on the minds of pharmas launching precision medicines.
However, Labceutics, a subsidiary of personalized medicine-focused consultancy Diaceutics, has been working to raise awareness of the issue. The firm 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 for personalized medicine products. The survey found that "pharma has forgotten laboratories are a critical stakeholder" in commercializing their personalized drugs.
More recently, there is growing appreciation among drugmakers regarding the importance of lab networks in delivering their personalized drugs, and pharma companies are working in different ways to increase access to standardized diagnostics on a global scale. One strategy pharma is investing in is the development of universal testing platforms, such as the 70-gene panel GE/Clarient is advancing. GSK also recently inked a deal with Thermo Fisher Scientific and Pfizer to advance a next-generation sequencing-based companion test that will be used to identify best responders in multiple drug programs currently underway.
In another example, Canadian firm Contextual Genomics announced plans to beta test a 90-mutation panel for predicting responses to marketed and investigational cancer drugs. In developing the panel, Contextual Genomics gathered input from 11 unnamed pharmaceutical firms on the markers they'd like to see on the panel based on the drugs they sell and are advancing through the pipeline. Many of these pharmas are also paying for the development of the test.
Similarly, in August, AstraZeneca, Sanofi, and Janssen Biotech also said they were working to develop a universal companion diagnostic on an Illumina NGS platform for drugs they were developing. These deals are all similar to the Lung Cancer Master Protocol (Lung-MAP), a National Cancer Institute-sponsored trial in which multiple drug firms are using Foundation Medicine's NGS panel to stratify squamous cell lung cancer patients into various therapeutic arms in a Phase II/III study.
Looking to the future when exome and whole-genome sequencing will be more readily used in clinical testing, platform developers are also tackling lab standardization by creating networks of providers that can perform these advanced tests in a standardized fashion. For example, Thermo Fisher subsidiary Life Technologies and Illumina have created lab certification programs for their exome and whole-genome sequencing platforms.
This article has been updated to attribute comments from GSK to Jonathan Pan. Previously, the quotes were attributed to a GSK spokesperson Philipa Wallace who relayed Pan's answers over e-mail.