User:Mac/Interviews

Interviews with experts. Questions:

1. What are diagnostics kits?
2. What is the typical development pipeline for a diagnostic?
3. At what stages in the pipeline is there IP activity?
4. Is there a "pipeline problem" for diagnostics?

Jim Hardy

Jim Hardy
Hemacell Perfusion
4539 Metropolitan Court
Frederick, MD 21704
(301) 639-6718

contacted 8/27/09 (headset not working, had to take paper notes)

• Jim was involved in the commercialization of the first FDA-approved DNA diagnostic test. It discriminated between benign and cancerous HPV tumors.
• Involved radiolabeled southern blot (IP protected)

Mark Redmond (via LinkedIn)

I solicited answers in response to my Research Question through a variety of avenues, including LinkedIn. Mark Redmond responded:

Dear Mac,

This is a question with a broad spectrum of answers since diagnostic kits are a broad spectrum of product. Speciality companies as well as general laboratory suppliers distribute Kits. Some kits are available in pharmacies and drug stores for testing for flu, diabetes, etc. Complex tests may also be performed by sending the developer who has the expertise to use the kit as well as the detection equipment necessary to read the kit's results.

The product life-cycle is typically method development, internal validation, clinical validation, and regulatory approval.

The method is typically:

Target + Detection reagent → Detector → Result

If required, the target is captured:

Capture reagent + Target + Detection reagent → Detector → Result

There are kits for a broad range of targets ranging from hormones, infectious diseases, metabolites, antibodies, and tumour antigens to name but a few. Biomarkers has become the accepted term for disease specific

There is a lot of work required to develop the reagents and the working dilutions for each of the reagents as well as ensuring there are no undesirable high backgrounds, false positives or false negatives produced in the test.

Once assembled, the complete kit may be protectable. Detection reagents and sequence probes and the methods to produce probes for examples primers, as well as proprietary cell lines used to prepare reagents, and antibodies may be proprietary as intellectual property..

Sample preparation of the target in the form of patient samples and specimens is also critical. Sampling tools and associated equipment are the subjects of intellectual property e.g. specialized nasal swabs and capture systems for flu detection (see the Flutest reference)..

The diagnostic method is also driven by the method of detection, for example, ELISA, RIA, PCR, and fluorescence as well as the phases of detection, liquid-solid, liquid-liquid, and tissue staining on microscope slides. The latest technology drive is towards arrays for multiple target screening - this method is also called lab-on-a-chip. [Detection methods and the equipment used for the detection are the subjects of intellectual property]

A major determinant in the utility of the test is the sensitivity and specificity of the assay. The more sensitive and more specific test the more useful and valuable it will be.

Having completed the development the next stage is evaluation and validation. Two types of evaluation are performed: (1) Analytical Evaluation where performance characteristics are measured and (2) Clinical Evaluation, where clinically annotated samples are available. Clinical evaluation is the demonstration of association of test results with a particular clinical condition or prediction of treatment response. Comparisons between similar assays can be drawn using the same standard clinical samples and analytes.

Test results are provided in a standardized format for ease of submission to FDA for review. FDA review and approval is the final stage before marketing as a validated test and a medical device for a specific indication.

I hope that this is a helpful broad overview and answer to your question.

Good luck with your project.

Links:

• http://www.ibl-america.com/?gclid=CKmYqt6qwJwCFSn6agodUEelmA
• http://www.flutest.com/rapid-flu-test