Babson Diagnostics Inc. has line of sight for the commercial launch of its Betterway blood testing ecosystem, which is a less invasive way of taking blood and requires only one-tenth of the sample volume of venipuncture without sacrificing quality or accuracy. The company said that once the collection device developed in partnership with Becton Dickinson & Co. (BD) is cleared by the U.S. FDA, Betterway will be launched in Texas, where it already has established partnerships with retailers and where its commercial lab is up and running. In addition, Babson has fully validated a broad set of miniaturized assays that are ready for commercial processing in its CLIA-certified, CAP accredited laboratory.
Some 40% of people are said to be skipping a recommended test or treatment because they are afraid of needles, or it is not convenient. In addition, over 50% of people have difficult veins where venipuncture does not work well.
Austin, Texas-based Babson is collaborating with Siemens Healthineers Inc. and BD and believes it can help patients and clinicians with its innovative technology and service.
Few drops of blood
New diagnostic blood technologies tend to raise red flags for those familiar with the Theranos controversy. However, Stein claimed that the now defunct company did get one thing right. It identified that there was an unmet need, and that people wanted an easier way to get their blood tested.
“People want convenience and accessibility and a true new way – a BetterWay – of getting their blood collected and accurately tested,” said Stein. “They also want those test results to be trusted by their care providers.”
Babson and its partners have reimagined end-to-end blood testing and developed a technology based on “a true science first approach that we believe will bring, a preferred alternative to people without sacrificing menu breadth and quality,” he said.
The BetterWay blood testing process starts with the collection of blood, which is done at convenient locations such as a pharmacy. The company has a finger collection device that does not require a phlebotomist and enables a trained pharmacy team member to collect a quality sample, about the size of a pea, to produce a broad range of diagnostic test results that can be used for annual wellness exams, condition monitoring and screenings.
Once collected, the samples are placed into a specially designed and patented sample preparation device for automated handling and temperature-controlled storage. BetterWay couriers then transport samples to the Babson laboratory where proprietary miniaturized assays maximize utility and minimize waste - almost all the blood is utilized for analysis – reducing sample waste by 93%.
“We don't dilute the sample, we've actually shrunk down the analytical process, so that each test needs less blood,” said Stein.
Stein claimed that Babson is the only company able to do broad routine panels from samples easily collected in sites such as a retail pharmacy. “You walk in, you get your collection done conveniently and then, the same day or next day, you get your results.”
The company has conducted more than 40 studies, with more than 600,000 tests completed.
Problem with point-of-care
The blood diagnostics sector is certainly changing, and several companies are coming up with solutions to change the way blood tests are done. Truvian Health Inc. and Vital Biosciences Inc. are working on point-of-care devices that can deliver lab grade results.
However, Stein, who prior to Babson was CEO of the Siemens Healthineers point-of-care division, claims that point-of-care devices are great when quick results are needed in a clinical setting for a patient to take a critical action. But, he said, that there are several issues that companies must deal with when they try to do broad point-of-care.
“The single use disposables in all those systems are incredibly expensive. There is a high level of complexity in the regulatory process because they will require a CLIA-waiver. It is a captive menu, so you have to run everything when you load that test. And the customers rarely want to wait around for 30 to 45 minutes to get their result.”
Therefore, he feels “point-of-care testing for broad routine panels is not the ideal structure and would not work well economically.”
What is more, many of the companies providing point-of-care solutions do not have a unique way of collecting the sample, claimed Stein. “Without a next-generation collection device, you would still need to do venipuncture, which means needing to hire trained phlebotomists. It wouldn’t address the issues with adherence and those who struggle with difficult veins and vasovagal reactions.”
“Our hybrid approach and differentiated technology brings the best of easy collection and full automation at the point of collection, together with the economies of scale, menu breadth and quality of processing on high volume systems. What Babson has done with its partners is to reimagine the entire blood testing process from beginning to end, making it easier for the patient, affordable and accurate.”
“We feel that retail convenience is really a game changer,” said Stein. “More and more people prefer to visit their local pharmacy for health care services. And then we back that up with an end-to-end technological ecosystem that will preserve the sample and will produce a result the customer and their care provider can trust.”