Have Stanford Researchers Developed the Blood Test Theranos Couldn’t?

April 24, 2023 - In January 2023, an article published in Nature Biomedical Engineering outlined research by Stanford scientists detailing the process of using a multi-omics microsampling blood test for health profiling. The idea of microsampling has been researched for years. Most notably, Theranos, led by Elizabeth Holmes, was under fire for fraudulently claiming to accomplish this goal using novel technology. However, Stanford researchers may have accomplished what Theranos never could.

LifeSciencesIntelligence sat down with Michael Snyder, PhD, chair of the genetics department at Stanford School of Medicine and the Center for Genomics and Personalized Medicine, to discuss the results of the Nature study and ongoing research. To complete the publication, Snyder worked alongside other co-authors, including Ryan Kellogg, PhD,  Xiaotao Shen, PhD, Daniel Panyard, PhD, and Nasim Bararpour, PhD.

He provided detailed information on the basics of multi-omics microsampling, the difference between this research and Theranos’ claims, and insight into future research directions.

The Basics of Multi-Omics Microsampling

Before diving into the benefits of this technology and the analyses done by his team, Snyder explained the purpose of microsampling and advancing the data extracted from blood tests.

“The way we practice health these days is flawed in many different ways,” he said. “First, it's mostly sick care, not healthcare.”

The claim by Snyder is supported by the poor access to preventative care and the astronomical costs associated with it. The standard focus on sick care has contributed to multiple preventable public health crises, including the rising rates of type 2 diabetes and the obesity epidemic.

Collecting detailed, patient-specific data can provide more insight into a patient's health status, enhance precision medicine, and may steer patients toward the appropriate lifestyle changes.

“We profile people very deeply with all kinds of measurements. We'll sequence a genome and take many measurements,” noted Snyder. “They're called omics measurements out of people's blood where we'll follow as many molecules as possible: RNA proteins, metabolites, lipids, and immune markers called cytokines. We also follow the microbiome and do a lot with wearable sensors.”

Multi-omics profiling encompasses a broad range of different measurements to generate omics datasets that include proteomics, focused on proteins; metabolomics, focused on metabolites; and transcriptomics, focused on transcriptomes.

“We've been trying this idea of taking small drops of blood mailed-in from patients and doing analyses,” said Snyder. Using his team’s technology, they can follow 2200 biomarkers in the blood, including metabolites, cytokines, and other vital proteins.

The Difference Between Theranos and Stanford

“We've had some success with this idea of sampling people at home, mailing in samples, and then being able to measure thousands of analytes a day from a tiny drop of blood. I know what that sounds like, but this does work,” Snyder laughed. “We spent six years developing it.”

The team did multiple things to prepare for and effectively support this research. First, they spent a long time determining the best, reproducible sample collection methods, settling on one that collects fixed amounts of blood.

From there, Snyder and his team could collect their needed quantitative measurements. Creating a robust product was a key focus point for this research. Comparing this type of microsampling to the widely known Theranos fraud, Snyder highlights the differences between Theranos’ technology and what he and other Stanford researchers are doing.

First, Snyder’s team uses state-of-the-art technologies, unlike Theranos. Although the procedure is mainly used in research settings, advanced technology helps position it for easy commercialization.

“My team is trying to use fairly advanced technologies. We're not just using standard immunoassays. We're using mass spectrometry, for example, which is known to be able to quantify many molecules and such. While we use immunoassays for certain things, it's a combination of both and not fixed,” added Snyder.

He explains that part of Theranos’ downfall was their fixed mindset. The company attempted to have an analysis device with a very fixed size despite knowing that the precise instruments were large.

“We're cautious about what we do. We ensure it's reproducible, publish our results for anybody, and make our data accessible. Anybody who wants to can scrutinize it. We have MDs who oversee the work we do. So we've tried to be very careful and as robust as possible,” said Snyder.

His team's transparency and validation efforts are a stark difference from Theranos’ secrets, which were unearthed during court proceedings.

Goals of Multi-Omics Microsampling

The research aims to provide detailed, accurate, and patient-specific data to help inform lifestyle habits and medical decisions. The current standard for extrapolating patient data from liquid biopsies involves standard bloodwork ordered by a prescribing physician.

While the current protocols have advanced significantly, blood draws still have limitations. For example, these technologies provide a small number of measurements alongside vital signs collected by a provider. Snyder estimates that routine lab work typically only offers 15 measures, a small portion of the larger picture.

“Where the world is now, we're capable of making thousands of measurements,” said Snyder. “The analogy I like to use is like a thousand-piece jigsaw puzzle. The way we practice medicine today, we're collecting maybe five or six pieces, whereas I think we can get 600 pieces and a much clearer picture of someone's health.”

Following his analogy, having 600 pieces of the puzzle provides a much better idea of the overall picture than having a handful. Similarly, having a lot of clinical data and bioinformatics specific to the patients offers better insight into overall health than a few standard measurements.

Beyond collecting data like blood glucose — still critical — multi-omics data can provide insight into immune responses, gene expression, metabolic response, protein concentrations, and more.

Healthcare V. Sick Care

“The other big aspect, which relates to this idea of healthcare versus sick care, is we're profiling people while they're healthy,” said Snyder.

Before a patient gets sick or suspects an illness, multi-omics can measure the patient’s baseline health profile. When a patient does get ill or suspects a condition, the test can be repeated and compared to the healthy iteration.

Additionally, it can provide information on genetic predispositions, allowing patients to adjust their lifestyles accordingly. For example, a patient whose test points to a genetic predisposition to hypertension may change their diet before taking medication to manage the condition.

Rather than comparing the patient to standards that may not apply, this technology provides patient-specific comparisons, advancing personalized medicine.

“If providers wait until people are sick, it's tough to reverse that. But patients have a much better chance if providers catch them while they're healthy and things are just starting to drift off.”

How Does It Work?

Snyder explained that the microsampling device could be compared to a tiny sponge that “takes ten microliters, a fraction of a drop of blood.” Two of them are collected for sampling.

Patients will prick their finger with a lancet — much like a person with diabetes does to check their blood sugar — and touch the absorbent collection device to the blood drop until it fills the sponge. Patients should repeat the process for a second sample and allow them to dry before mailing it back.    

Upon receiving the sample in the collection device, researchers like Snyder can analyze the biochemistry of the blood sample, targeting the key molecules he previously mentioned.

“Now, it's not a clinical diagnosis,” emphasized Snyder. “It's not an FDA-approved test or anything. It's still in the early days. We call it a wellness test.”

Patients can use it as a general assessment of wellness to get a better understanding of where their health stands. However, before making definitive changes, the commercial test results should be corroborated by additional testing with FDA-approved technology.

Although there are some limitations, this tool’s convenience is one benefit. Rather than taking time off work or making the trek to get lab work, patients can receive the test right to their door, mail it out, and have results within a couple of weeks.

In the future, Snyder and his team hope that newer iterations can deliver results in days.

Beyond convenience and speed, these tools can provide patients with a relatively inexpensive and frequent health assessment, allowing them to make lifestyle changes as necessary.

“It's a much broader assay than what you would get from the doctor's office, giving patients a much clearer picture of what's going on.”

Commercialization and Future Progress

Snyder revealed a commercial version that can be purchased from YOLO. While the technology used for research purposes analyzes many more points, the commercial version still measures 500 analytes.  

“I envision, in the long-term, people will follow themselves with their smartwatch continuously, and then they'll do this pricking at some frequency. Maybe it's monthly, I'm not sure, where patients could get a clearer picture of their health. So if something shifts, they would catch it as early as possible,” said Snyder.

“As this technology improves, testing will get cheaper. I hope this test becomes part of the healthcare routine in the future,” he concluded.