SomaLogic is developing a range of protein signature-based applications to address unmet clinical needs across a range of diseases. Development of applications proceeds through a number of distinct stages, from Feasibility to Registration and Launch. SomaLogic is already actively pursuing Feasibility Studies and Marker Discovery and anticipates offering its first signature-based diagnostics in 2010. Progressing from feasibility to commercial launch will generally require two to five years per indication.

During the Feasibility Study stage, SomaLogic researchers look at a broad clinical area, such as rheumatoid arthritis. Serum samples from patients with the disease of interest are compared to normal controls to determine whether there are any protein markers that can be used to distinguish the two sets. You can learn more about SomaLogic's current Feasibility Studies by clicking on the first purple arrow, above.

During the Product Marker Discovery stage, researchers identify proteins that are associated with the specific clinical question for which an application is being developed. An introduction to the Product Marker Discovery process is provided here. You can learn more about SomaLogic's current Product Marker Discovery trials by clicking on the second purple arrow, above.

Successful marker discovery studies lead to Signature Discovery. During Signature Discovery, a larger number of samples are examined to confirm the Product Marker Discovery results and learn how the information content of multiple markers can be combined into a single signature, providing more diagnostic certainty for clinicians and patients. Preliminary verification may also be included in this phase, providing the basis for early launch on a service basis (homebrew assays offered through CLIA "high-complexity" laboratories).

If a signature has been discovered, it must then go through Signature Validation to confirm that it works in larger numbers of patients, in more diverse populations, with different testing laboratories, etc. Validation studies will be required before seeking FDA approval for any particular application product. Signature Validation studies are the largest studies that SomaLogic will undertake, and may involve hundreds of patients or more.

Finally, during Registration and Launch SomaLogic submits data from clinical trials to regulatory authorities, gains approval, and introduces the product to the market. In addition, reimbursement issues must be addressed with key public- and private-sector payors.