Blood-Test Tech Moves Beyond Theranos Failure

"Theranos's ambitions for a finger-prick blood test are finally being realized -- by other companies.

Since May, needle-phobic people in Austin, Texas, have been able to visit pharmacies for routine medical tests on drops of blood squeezed from their fingertips, rather than the usual way of plunging a needle into a vein in the arm and drawing large vials of blood.

The rise and fall of Theranos -- the Silicon Valley startup that promised to revolutionize blood testing but ended dissolved, with its founder Elizabeth Holmes convicted of fraud -- cast a pall over the idea that critical medical tests could be run on mere drops of blood.

Demand for alternatives to standard blood draws never went away, however. And companies -- including Becton Dickinson and Babson Diagnostics, which make the tests rolling out in Austin -- have been working out technological kinks that foiled Theranos.

Becton's hand-held finger-prick device and Babson's sample-handling machine are the first to hit the market. Drawbridge Health received regulatory clearance in April for a device that collects a small amount of blood from the upper arm and can be self-administered at home.

Truvian Health is developing an instrument that can process small blood samples close to the point of collection rather than at a central lab. The company plans to launch it commercially in 2025, Chief Executive Jay Srinivasan said.

Theranos has "always been a two-edged sword in that it put a stain on the integrity of the industry that I don't think will ever go away," said Eric Olson, founder and chairman of Babson. "And at the same time, it awoke the idea that things can be different."

Theranos was valued in the billions of dollars based on the promise to test blood using just a few drops. The Silicon Valley startup formally dissolved in 2018 after The Wall Street Journal exposed how the company's technology didn't work. Holmes is now serving an 11-year prison sentence.

The company had tapped heavy interest in something faster and less painful than standard blood draws, which can take 6 to 12 milliliters or more.

The draws are a staple of medical testing used to gauge everything from whether someone is diabetic to whether they have a vitamin deficiency. Yet many people fear needles or have trouble presenting a suitable vein on the first try.

Some avoid the tests altogether, which could cause doctors to miss diseases.

Geraldine Tunnell, a 47-year-old technology executive in Austin, previously got standard blood draws every three months to monitor the Type 1 diabetes she has had since childhood.

It was a tough process because phlebotomists often had to inject a needle several times before finding a suitable vein in her arm. Sometimes it took up to an hour to get it right, causing bruises, she said.

Tunnell recently went to a nearby pharmacy to get the Becton and Babson blood test. She said the visit took about 30 minutes, and she didn't have to worry about difficult-to-find veins. Nor was it any more painful than the fingersticks she has used to test her blood sugar.

She received a text the next morning with a link to her results, which showed her average blood-sugar levels were well controlled.

"That is a far easier way to do it for me," she said. "You can certainly feel it, but it felt significantly different for me than when they had to poke around my veins."

Becton, a Franklin Lakes, N.J., company that makes needles and tubes used in standard venous blood draws, developed the BD MiniDraw device that uses a fingerstick lancet to collect drops of blood.

The hand-held device has a finger sleeve attached to a tube, which typically squeezes about six to 18 drops of blood -- less than 1 milliliter.

Babson, an Austin company that was spun out of medical-technology giant Siemens Healthineers in 2017, uses the BD MiniDraw in a retail blood-collection service it calls BetterWay.

Pharmacists can administer the blood collections, rather than the phlebotomists who perform standard blood draws.

Before getting the fingerstick, consumers place their hands on a warming device to improve blood flow in capillary vessels. They slide a finger into a plastic sleeve and get pricked by the lancet, and a pharmacist can then squeeze wings on the sleeves to cause blood to flow out.

The tube of blood is put in a Babson sample-preparation machine on site, which scans it and conducts reverse centrifugation, a process that separates serum and plasma from the blood. Babson says this process greatly reduces the amount of blood that is often wasted in standard blood draws.

The samples are sent to a centralized Babson testing lab in Austin, where the company processes samples on analyzers from Siemens Healthineers that have been adapted for small-volume testing.

Theranos had sought to use its own proprietary instrument, named Edison, to quickly test customers' droplets of blood at the site of the finger prick. The Journal reported the device had accuracy issues and was barely used.

Babson, by contrast, uses more-conventional analyzing equipment at a central lab to test the samples.

"This isn't Theranos," Olson said. "We're not trying to minimize the lab. We're decentralizing the collection and taking it back to the laboratory."

Babson and Becton said clinical studies have shown lab results from the fingerstick blood samples are clinically equivalent to standard venous tests. They plan to publish the results in a medical journal.

For doctors to gain confidence in the new method, it will be crucial for Becton and Babson to publish the clinical data demonstrating its accuracy across a range of patient populations, said Dr. Charlene Bierl, professor of clinical pathology and laboratory medicine at the Perelman School of Medicine of the University of Pennsylvania." [1]

It seems that the Wall Street Journal, looking for more reader interest, ruined a pretty normal startup - Theranos, that earlier did exactly the same work as these companies today. All startups have technical difficulties in the beginning. What a shame...

1. Blood-Test Tech Moves Beyond Theranos Failure. Loftus, Peter.  Wall Street Journal, Eastern edition; New York, N.Y.. 31 July 2024: A.1.