A very insightful article about Theranos by Thomas Lee was recently published in the San Francisco Chroncle. It makes some very telling points regarding the company's relationship to the FDA (see: Theranos CEO Elizabeth Holmes needs to grow up, and fast). Here is an excerpt from the piece:
The Food and Drug Administration had granted 510(k) approval to Theranos’ testing system for herpes.“FDA’s review process for 510(k) notifications is widely recognized as one of the most rigorous regulatory hurdles in the world for evaluation of the performance and accuracy,” the company said. “Today’s announcement demonstrates that Theranos has met that standard and is an important step in Theranos’ mission to ... [empower] individuals everywhere with information to live healthier lives.”
Given the breathless tone of the statement, you would think that Holmes had just won the Nobel Prize for Medicine. But it turns out 510(k) approvals are pretty standard in the medical device industry. And contrary to what Theranos suggested, 510(k) does not mean the agency has blessed the “performance and accuracy” of the company’s technology. It simply means that Theranos’ tests are pretty similar to a previously FDA-approved device on the market.“The 510(k) clearance is not a determination that the cleared device is safe or effective,” according to an Institutes of Medicine report, commissioned by the FDA itself.
Continuing in this same direction, here are quotes from the FDA's actual 510(k) report (see: 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY):
The TheranosTM HSV-1 IgG Assay is a chemiluminescent immunoassay intended for the qualitative detection of IgG antibodies to herpes simplex virus type 1 (HSV-l) in human serum, in K2-EDTA anti coagulated human plasma from venous blood, and in human fingerstick K2-EDTA anticoagulated whole blood obtained with the Theranos Capillary Tubes and Nanotainer Tubes.
The Theranos HSV-1 IgG Assay reagents are packaged in a ready-to-use pouched cartridge and are designed to be used directly. No additional preparation of reagents is required. The Theranos HSV-1 IgG Assay is intended to be run on the TheranosTM TSPU [Theranos Sample Processing Unit] Device only.
Let me repeat the key sentence from Lee's story above: [The 510(k) approval for the Theranos herpes test] means that Theranos’ tests are pretty similar to a previously FDA-approved device on the market. What the FDA has approved is a chemiluminescent test for herpes running on the Theranos analyzer, referred to in the report as the Theranos Sample Processing Unit (TSPU), with a "pouched cartridge" containing reagents and into which an aliquot of serum is injected to measure the herpes IgG antibody
FDA tends to be a conservative in assessing new lab testing devices which is appropriate given that it is tasked with protecting the health of citizens. Approval via 510(k) path requires "substantive equivalence" with a "predicate device" (see:The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]). The idea of a chemiluminescent immunoassay and a pouched cartridge sounds similar to current analyzer technology. Theoretically, the idea that the Theranos assay uses only micro-aliquots of blood could be construed as a radical approach to lab testing. Here again, however, there are precedents dating back decades. Blood is commonly obtained from premature infants and newborns with a heel stick and with blood drawn into a capillary tube. Here's a link to a list of the pediatric test menu in one hospital that can be performed today after drawing micro-liter amounts of serum/plasma (see: Pediatric Blood Specimens).
In my opinion, what is remarkable about the Theranos business model is the emphasis on direct access testing (DAT) and using the Walgreens health center as blood drawing stations. The emphasis of the company on broad and inexpensive access of healthcare consumers to their lab test results is highly commendable. However, the evidence presented here suggests that the Theranos analyzer using test cartridges may be less revolutionary than evolutionary.