Product Development

We have developed and refined our technology in over five years of research service collaborations, and we operate what we believe is the world’s most advanced biomarker discovery platform. Our product development process comprises planning, biomarker discovery, development of molecular diagnostic tests based on biomarkers, and commercialization of those tests. The figure below summarizes our expected path from biomarker discovery to molecular diagnostic commercialization.

Our technology platform enables us to efficiently conduct biomarker discovery projects and to make an early decision on whether or not to advance a biomarker for further development. The discovery phase of a project typically lasts three to four months from receipt of the samples. Once a biomarker is determined to be suitable for advancement, we proceed with full development of a new molecular diagnostic product as described below.

Product Development Process from Discovery to Market

Discovery
Planning: Through the planning process, we initially identify a product opportunity as well as the source of samples for discovery. A preliminary research plan and a project timeline are established for each product program.

Biomarker Discovery: Our discovery phase involves measurement of over 1,000 different molecules in as little as two drops of various biological fluids or from tissues of interest, such as biopsy material. We analyze the resulting data using proprietary statistical models to identify single or multiple molecules that compose a candidate biomarker.

Development
Verification: Through verification of a biomarker, our objective is to demonstrate the reproducibility of the discovery findings by measuring the biomarker in clinical samples that are different from those used in the discovery phase.

Assay Development: Concurrent with biomarker verification, we begin work on assay development. During this phase, our goal is to produce a molecular diagnostic test for the biomarker in a format that is suitable for use in commercial laboratories. Appropriate formats, such as, enzyme-linked immunosorbant assays, called ELISAs, chromatographic assays, colorimetric and spectrophotometric methods, are among those considered. We may test more than one suitable method and choose a preferred assay format based on its performance characteristics. The final diagnostic assay may include more than one format if the biomarker includes more than one type of molecule, such as proteins and metabolites. We will also evaluate and select any software and algorithmic tools required for the molecular test as part of this assay development process.

Clinical Development: In clinical development, we seek to demonstrate that the assay selected accurately and reproducibly measures the biomarker of interest, and that the biomarker measurement provides clinically meaningful results. To do this, we will conduct one or more studies with appropriate clinical endpoints to both validate the assay and to qualify the biomarker. These clinical studies provide the data that, together with all other study and assay information, form the basis for seeking regulatory clearance.

Regulatory Preparation and Submission: We are committed to applying development protocols and methods for all of our products in accordance with accepted regulatory guidance. We will proactively interface with the FDA and other regulators throughout the development process to solidify the development plan and protocols for each new molecular diagnostic product. We believe that involving the regulatory agencies early and frequently during development will improve the probability and timeliness of regulatory acceptance for our products.

Launch
Market Planning: At this stage, we will determine an appropriate commercialization plan for each specific product, and we intend to structure our regulatory submissions to be consistent with our strategy for commercializing the product. We will pursue one or a combination of the following approaches: a laboratory testing service, direct product sales or out-licensing. For each of these approaches, we will ensure that an appropriate infrastructure is in place to support all aspects of commercialization.