How to Outsource Development of Clinical Diagnostic Assay

For decades the model for how a clinical diagnostic assay (otherwise known as a clinical diagnostic, or a diagnostic test) was developed remained unchanged. Large cost-intensive research labs in companies like Quest Diagnostics or Labcorp, manned by dozens of scientists, worked for years at the bench to identify a new disease marker. Today we are at a tipping point in that model, and Scientist is working hard to break the old, slow, high-cost, development model and turn it into a fast, cheap one. Outsourcing the entire process is now possible, and with the use of Scientist and other tools, outsourcing options are now available to any interested party with a computer, access to the internet, a spreadsheet, and some basic biology and statistics knowledge.

Stanford Medicine showed us how the playing field was changing with their profile of Purvesh Khatri a researcher working on pediatric cancer.¹ Their compelling article follows Dr. Khatri through the process of discovering, developing, and validating new diagnostic tests for cancer. What is all the more remarkable is that he achieved all of this using only his laptop computer.

To paraphrase the Stanford article, the recipe for a new diagnostic assay is:

• Mine publicly available experimental research data to find promising cancer markers. You can find this type of data at NCBI GEO (ncbi.nlm.nih.gov/geo). Cost $0
• Select your list of potential cancer markers (this is where the spreadsheet and some basic statistics skill come in). Cost $0
• Obtain some blood samples from cancer patients and healthy volunteers. You can get these samples from a tissue bank such as conversantbio.com or usbiomax.com. Cost $1000 for 20 samples.
• Find a contract lab to test your blood samples for the levels of your suspected cancer markers. You can find these contract vendors through Scientist. Typical cost is $2,000 - $3,000 per target you want to test. If one of your markers shows up at a different level in the cancer patients versus the healthy volunteers, you have your diagnostic. (Congratulations!)

Total cost: (assuming you take 3 markers all the way through to testing) $7000 - $10,000)

Total time: 5 - 10 weeks.

The paradigm of scientific research is changing. For the first time it is truly possible for a dedicated individual with a few thousand dollars and a laptop to identify genetic markers for a disease and to take those markers all the way through testing and validation with clinical samples, and the only equipment you need is your laptop!