Blood testing nears a turning point as the evidence becomes undeniable

Red blood cells
Theranos’ legacy has cast doubts on other potentially disruptive technologies, but a steady march of clinical data and engineering successes have shown that these ideas can work when done right. (Pixabay)

Blood has always held the keys to our bodies’ health: it helps carry nutrients in and waste out, and interrogating it can provide solace when we are well and answers when we are sick.

Blood testing is ubiquitous, but it’s clear its possibilities are unfulfilled. Through different methods and modalities, these diagnostics promise to be a more accessible, less invasive, smarter, cheaper and a comprehensive way to gather knowledge about what’s going on under the skin—whether in a doctor’s office, at home or within a clinical laboratory.

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The field has seen setbacks. Theranos’ well-parsed rise, fall and legacy have cast doubts on other companies’ efforts to develop potentially disruptive technologies, especially those along the same lines. But a steady march of clinical data, engineering successes and FDA backing have shown that, yes, these ideas can work when they’re done right. And in 2020, blood-based diagnostics, liquid biopsy tests and their makers may all reach a watershed moment.

Take Truvian Sciences, for example. The company just raised $27.1 million to further its countertop blood testing machine, which aims to subject a single blood sample to 40 of the most common analyses ordered by physicians, and in nearly any location. Sound familiar?

When taking that pitch to prospective investors, how many do you think said: “Well, I’ve heard that one before”?

“The answer to that question is everybody,” Truvian President and CEO Jeff Hawkins told FierceMedTech.

“In the end, I think what Theranos did do is that it created a shift in the market—where there are investors who say, ‘We’re comfortable diligencing technology, teams and regulatory strategies,’ and were willing to invest in our series B,” said Hawkins, who previously served as VP and general manager of Illumina’s reproductive and genetic health business. “They understand the path it takes to get from here to a product.”

“And then there were other investors who—maybe from their takeaway from the Theranos time and thinking about their own capabilities—were saying, ‘No, we’re interested in what you’re doing, but we’ve decided as a fund to wait to invest in this space until a company makes a submission to the FDA,’” he said.

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The skepticism Truvian received actually evolved as more and more of the Theranos story came to light, not to mention the debut of the comprehensive book by the Wall Street Journal’s chronicler, John Carreyrou.

Early on, while there were concerns that Theranos’ claims were a fraud, the story also made the technical challenges sound insurmountable. But after it became clear how deep the fraud itself ran—and that their flawed approaches were not the only way forward—questions about engineering obstacles became less frequent, Hawkins said.

Instead, “it put a tremendous amount of emphasis on the team you were building, and the types of investors or independent advisors that were in the company and planning to participate,” he said. Then came the scrutiny of the company’s validation strategy and regulatory path, and in much stronger terms than before Elizabeth Holmes’ time in the spotlight.

Out from Theranos’ Shadow

Since then, we’ve seen companies like Guardant Health, which showed that its blood-based cancer DNA test could actually outperform traditional tissue biopsies when profiling non-small cell lung cancer cases. Meanwhile, Grail’s liquid biopsy demonstrated it could detect and differentiate a dozen early-stage cancers before they had a chance to metastasize to the rest of the body. And Foundation Medicine’s blood test proved it was able to predict higher risks of breast cancer recurrence by sifting out genetic material from tumors. 

One of the companies contributing to the bevy of supporting clinical data is the cancer-focused Epic Sciences, maker of a liquid biopsy that profiles tumor cells found circulating in the bloodstream.

At this month’s San Antonio Breast Cancer Symposium, Epic presented two research studies of people with metastatic or triple-negative disease, showing its technology could spot the underlying genomic biomarkers by observing the shapes, features and differences between cells.

By classifying and sorting these commingled cancer cells from blood samples—and identifying which cell groups may be weak to certain drugs, while others may not—Epic believes its test could help predict overall responses to treatment.

“Just by looking at the cells and using some fancy artificial intelligence and a computer vision program, we can segregate these cancer cell populations,” said Chockalingam Palaniappan, Epic’s chief technology officer. “That can tell you that your prognosis is poor, but that you may actually respond well to a PARP inhibitor or you may well respond to cisplatin versus the current drug regimen.”

“There is a high degree of genomic instability inside these cells, and just by visualizing them, we can do a genotypic interpretation by looking at morphological features. That's a big deal,” Palaniappan added.

He describes Epic’s single-cell profiling approach as looking for a needle in a haystack full of needles. You can look for the shape of an individual needle—that is, the cell’s physical characteristics—but you can also analyze and match the threads tied to the needle’s end, by sequencing their DNA. Other times, you can observe how the needles interact with each other.

“The beauty of Epic's technology is that from a single tube of blood you can get comprehensive cancer profiling—with genotypic analysis, phenotypic analysis and immune profiling, plus single-cell and circulating tumor DNA sequencing,” Palaniappan said.

“If you can do that, then you have a very comprehensive view. And that's what the world is evolving towards,” he said. “Patient’s blood is very precious. You want to get that comprehensive cancer profiling from that one tube of blood that they have to offer.”

FDA Clearance and Market Potential

One step in that evolution has already been taken by the Israeli startup Sight Diagnostics, which received a coveted FDA 510(k) green light this month for its countertop blood cell counter. 

Similar in form factor to Theranos’ and Truvian’s objectives, Sight’s OLO analyzer uses two drops of blood to perform a complete blood count analysis, or a CBC test.

Through digital microscopy and AI vision, the system visually tallies the numbers of red blood cells, white blood cells and platelets to give a quick snapshot of a person’s health. Included in over 90% of baseline blood tests, CBCs can also help determine if an ailment is viral or bacterial.

Going forward, Sight hopes to obtain a waiver from CLIA laboratory regulations that would allow OLO’s use in smaller U.S. practices and retail pharmacies. That could potentially increase the number of potential sites for the device by 10 times, according to Sight’s chief commercial officer, Assi Gol.

“That is always been our path. We have every intention to go down that line,” Gol said. “In everywhere that we operate in the U.S., it is clear that the people we deal with are disciplined, and data- and evidence-driven. But without an FDA approval it’s a non-starter.”

According to Gol, one of the factors shaping the industry is the drive toward “smartwatchification”—or the drive to shrink everything that can be shrunk, until it can fit on a person’s wrist.

“Things are becoming smaller, closer, more constant and less painful,” he said. “Anything we can do with a finger prick and not a venous sample will be done with a finger prick and not a venous sample.” 

The science and the proof just have to catch up.

“In the early days there were some concerns about whether the technology was sensitive enough,” said Epic’s Palaniappan. “But now the physicians are accepting, the data is supporting, and the FDA is approving…It's the culmination of things that were all happening disparately, and that's why this is going to take off in a big way.”

“There are investors willing to deploy their capital into diagnostics,” said Hawkins, whose Truvian is also pursuing a CLIA waiver to get its device into the retail setting. “And I think that's got a lot to do with mounting evidence, but I also think it has a lot to do with the conversation on the cost of healthcare.”

“More and more people are talking about the fact that you need to be screening, that you need to move to prevention—that's where the real cost savings comes from, on the preventive side, where you have the ability to screen for things and catch them early enough,” he said.

And as companies produce finer molecular sieves—capable of extracting more data from a single sample—their size will shrink and companies will work to get them in front of as many people as possible.

“When I was eight, I used to watch Star Trek and they had the tricorder, that could do everything from the palm of their hand,” said Gol. “I think that dream is still true, right? I’m just excited to be part of a step on that journey.”

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