Talk:Diagnostic Kits

Field Definition

working definition

Genetic Tests are clinical diagnostics based on the analysis of human DNA to determine genotype and corresponding health states, such as disease diagnosis, prognosis, recurrence, and differential drug response. (see SACGHS Patent report, pg 5).

Currently there are genetic tests clinically available for over 1574 diseases according to genetests.org.

The SACGHS Oversight report (pg 65) describes the two paths genetic diagnostics typically follow from research bench to clinical practice: a complete in vitro diagnostic kit may be developed and sold commercially to multiple laboratories, or laboratories may develop and validate a test solely for use internally, often with the use of analyte-specific reagents; these tests are called laboratory-developed tests (LDTs). The two paths are subject to different regulatory requirements; generally, IVD kits are more stringently regulated by FDA, which considers kits as in vitro diagnostic devices and may require premarket review or approval.

Both types of diagnostic, IVDs and LDTs, must be analyzed in CLIA-certified labs.

Genetic diagnostics are usually classified as "esoteric tests" along with other molecular tests based on non-genetic biomarkers. Esoteric tests, contrasted with routine tests, typically test for rare or unusual health conditions and are more sophisticated or involve increased complexity and human involvement.

Although market data is readily available for molecular and esoteric diagnostics, it usually is not broken into further sub-categories, making it difficult to find market information specifically for genetic tests.

The two largest national independent clinical laboratories, Quest Diagnostics and LabCorp, sold 2.78 billion worth of genetic & esoteric tests in 2008 (from annual reports; not clear if that revenue is from IVDs or LDTs or both).

Focus Market Segments

From initial R&D to the moment when a target product is clinically available, we will study the following:

• Data production: genotype-phenotype associations,

• Narrative production: Journals focused on biotechnology and related disciplines; descriptions of tools or patents, policy reports on genetic "ELSI" concerns.

• Tool production: platforms for analyzing DNA, calibration and reference standards, tissue samples for clinical trial and validations

Deprioritized Market Segments

• post-commercialization marketing
• regulatory?

Excluded From Field Definition

• non-genetic IVDs
• in particular, not Protein-based genetic tests. (see SACGHS Patent report, pg 5).