Theranos and Some Questions

This post was originally published on my blog which no longer exists so I decided to re-publish it here with some adjustment.

Theranos the startup company which offer low cost lab test is received approval from Food and Drug Administration to perform herpes simplex 1 test outside the lab, according to TechCrunch. The approval classified as CLIA Certificate waiver that will allow testing outside the lab with little error. Here’s the link from FDA site.

The Founder, Elizabeth Holmes when talked at Techcrunch’s Disrupt Conferences told that Theranos aim to perform lab test with only small amount of blood which can be obtained from a simple finger prick at low cost. Recently, a few bad news hit Theranos. Latest one is they got a letter from government for its Newark lab. If you want to know how’s Theranos performance on its blood test, here’s Jean-Louis Gassée experience using Theranos on Monday Note.

Since I work as an QA Officer of one clinical laboratory, Theranos quickly gets my attention.

First, I’m wondering what’s the technology behind Theranos device which make it’s possible to run the test with only few drops of blood. On a regular lab test, the patient’s blood need to be taken with venipuncture and processed to produce serum which we’ll run into analyzer. You’ve to go through pre-analytic, analytic and post-analytic process carefully to produce reliable and accurate result. When big analyzer perform test based on spectrophotometry even to mass-spectrophotometry method to analyze sample, the question is what method does Theranos devices use to produce the result? The reliable result?

Secondly, about its quality control. On regular lab test using analyzer, we need to perform quality control before we run patient’s sample. We run the control material and plot it against Westgard or Sigma rules. The purpose of running control is to ensure that all the test system which we use is running properly and produce acurate result. Again, my question is how the perform quality control on Theranos devices? Do they only need to be calibrate it once and it’s ready to go or what?

In addition besides method and quality control is cost. We all clinical laboratory try to give the best value for our customer. Ideally it would be low cost lab tes, quick turnaround time and acurate result. Maybe it’s not an apple to apple comparison since on the regular lab there would be a lot of additional material which is used in the process. But let me write this here, the new HSV1 which is newly got approved by FDA by Theranos costs $9.07, while today on our lab HSV1 costs approximately $25 using automated analyzer. Theranos’ HbA1C test which is used to monitor average glucose level in the blood for the last 2–3 months, cost $6.67, on us it’s $12.33

Of course the higher price not just from the reagent but also the result of the additional material we use to perform the test from pre to post analytic such as syringe and vacuum tube to collect the patient’s specimen, tube to store the serum and more.

Sure, Theranos technology could benefit us to the future. Performing lab testing outside laborartory with less errors means we could bring the device to remote areas. It would be more practical tho. The patient also could take the benefit from its system since it would be less pain when obtaining specimen, less blood to be taken.

I’m happy to know what method of their device or instrument use to examine the sample. Latest news from The Verge is they will be holding a “roundtable” meeting in February and March to discuss it’s technology and report it publicly. But until this post is published, I still couldn’t find any journal discusing what they use and how they produce the result. Or am I not digging deep enought? Maybe.