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CompanDX Expands Service Offerings, Internal Capabilities with CRL's CLIA Lab


Originally published Feb. 21.

By Turna Ray

UK-based CompanDX is working with laboratory testing services provider Clinical Reference Laboratory to expand its capabilities to develop biomarkers into clinical diagnostics and advance companion diagnostics with drug developers.

Under the terms of the multi-year agreement, the partners will advance diagnostic tests, from biomarker discovery to test validation, applying CompanDx's Risk Distiller bioinformatics tool and CRL's CLIA-certified laboratory services.

"The relationship with CRL is all about providing an extended service offering to industry," Andy Sutton, CompanDX CEO, told PGx Reporter this week. "For pharma partners CRL and CompanDX have the potential now to offer biomarker discovery from clinical data sets utilizing the Distiller bioinformatics [tool]. The natural corollary to discovering a biomarker panel that stratifies a clinical cohort is the need to translate that to a workable platform than could be routinely run in a regulated lab and this is where CRL's capabilities come to the fore."

It is no secret that drug developers are challenged when it comes time to settle on an optimal biomarker strategy with which they can confidently advance their targeted drugs into later stages of development. CompanDX and CRL are planning to work with pharma to validate biomarkers and develop companion tests that can be used to design stratified trials for personalized drugs.

"It is quite common for pharma to gather extensive datasets on a whole variety of platforms in the earlier phases of clinical development, knowing that this is important. What is less clear is whether there is a clear coherent strategy on how to discovery the optimal biomarker panel," Sutton said. "CRL and CompanDX can now explore these large datasets to deliver a robust working assay that can be used to select patients for later clinical trials, monitor response, and even identify early therapy escape."

While individually, both CRL and CompanDx have been approached by drug industry players to offer biomarker services to inform their development programs, together the partners are hoping to provide a more complete service package. "CompanDX has clients lined up, where if a successful biomarker panel is derived, CRL will be able to step in, format the assay, and be positioned to run stratification on the later stages of clinical development," Sutton said. "Similarly CRL has clients where from previous contacts they are aware of a discovery opportunity that CompanDX can step in."

Recently adding diagnostics development to its existing biomarker services offerings to drug companies, Compandia changed its name to CompanDx last year. The lead diagnostic in CompanDx's internal pipeline is its 31-gene Time-to-Event breast cancer test, which uses the Risk Distiller tool to predict whether a patient's cancer will metastasize (PGx Reporter 9/15/10).

Additionally, the firm has been developing a pulmonary tuberculosis test, based on a three- and four-gene signature that can distinguish between the active and latent form of the disease. This prototype TB test, which is also based on the Risk Distiller platform, may be potentially useful in understanding the emergence of the active form of the disease from latency, according to the company.

According to a statement from the company, early studies involving the TB test's gene signature shows a "marked transition from an inhibitory to stimulatory tone to the transcriptome … [that is] entirely consistent with the disease." Additionally, CompanDx has identified genes that could be potentially predictive of TB, which appear to cluster around "proteasome function, autophagy, antigen processing, and host defense."

CRL will provide lab services in the development of both the TB and breast cancer tests. Additionally, "CompanDX has drawn a considerable interest on both [the Time-to-Even and TB] projects and has leading labs ready to collaborate on these first translations of CompanDX signatures to real world tests," Sutton noted.

He added that the company is starting a fundraising round to gather resources to build a sales team and to conduct a proof-of-principle study for its Time-to-Event breast cancer test.

Although oncology is currently CompanDx's top focus, the company is also conducting research into biomarkers linked to cardiovascular and infectious diseases. According to Sutton, the company has also generated gene signatures for diseases impacting the central nervous system and women's health, asthma, and COPD. "It's just [in oncology,] where the field got started, that has dictated the heaviest use of biomarkers, but increasingly, we see requests outside of the oncology setting," he said.

CompanDX is exhibiting its Risk Distiller bioinformatics tool at the Molecular Medicine Tri-Conference in San Francisco, Calif., Feb. 23 – 25. At the same conference, the company will also present three posters on the Time-to-Event breast cancer test, its "Effect-Based" TB tests, and a systems biology tool, called "Therapy Distiller."

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