A TALE OF 137 TERABYTES: WEBINAR TALKS ABOUT DATA OPPORTUNITY IN IVD THANKS TO WEARABLES AND AI
Imagine 60 laptops. Now imagine that’s how much data is being generated every day by clinical providers. This was the point emphasized by Frank Criscione of Broadbranch Advisors (www.broadbranchadvisors.com) during the EYE ON IVD “Very Cutting-Edge Trends in IVD Webinar. In 2023, he said, clinical diagnostic providers globally generated an estimated *137 terabytes of data daily. This massive volume highlights the growing data generation trend driven by an aging population, increasingly sophisticated diagnostic tests, and emerging technologies.
The video of the VERY CUTTING-EDGE TRENDS IN IVD WEBINAR can be found here: “Very Cutting-Edge Trends in IVD” Webinar Video and Transcript – Eye On IVD
“The more data we generate, the more challenging it becomes for a single provider to analyze it all,” Criscione said, referring to the mounting pressure on healthcare systems to manage and interpret this information effectively. Why is this happening? The surge in data is also fueled by wearable technologies, like the Dexcom glucose monitor, which provide continuous biometric tracking.
These devices, first popularized by fitness wearables like Fitbit, now measure more complex metrics such as glucose levels, creating streams of personalized health data.
Criscione described this as a “good problem to have,” noting the opportunity for more precise healthcare but also the challenge of processing and integrating such data into patient care. AI tools are becoming indispensable in addressing this challenge, analyzing vast datasets to uncover trends and inform better diagnoses.
Criscione continued on how it changed patient visits. [With the terrabytes of information] “The second you sit down and they try and do your intake, and to be able to have that ability to monitor your resting state, day to day, when you go to the doctor initially, they can wind up seeing, ‘Hey, this is actually a better way to get a baseline for this particular patient. Better way for us to determine the state and determine if there if there are any aberrants or aberrations in that patient’s profile.'”
Criscione says data was always generated. But wearable growth has fueled more data and now with AI technologies, we can now handle the amount of data: “And so we have the {AI} technology, and it is currently being used. And now we’re just waiting to see who’s going to marry the two together and put all this biometric data into patient care specifically,” Criscione said.
Who will be the first in IVD to figure it out?
Among the many predictions made in our latest webinar, “Very Cutting-Edge Trends in IVD” was that we can expect a “lab-in-a-box” type system to receive FDA approval within the next 2 years. We’ll explain why here.
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BACKYARD INFECTIONS
You are not likely to get a burkholderia pseudomallei infection. It is, after all, not spread from animals, it’s spread from the soil. It is spread from cut on skin that is exposed to dirt, or in rare cases, from exposure to soil that has entered the airstream, say in an extreme storm. If that sounds terrifying, it should be comforting to know it’s rare. In fact, it wouldn’t have been a concern of in vitro diagnostic manufacturers, nor government agencies funding test development, if this were 10 years ago.
Yet like a lot of things, times are a-changing. Severe weather events, such as hurricanes and tropical cyclones, can increase the risk of the bacteria becoming airborne and infecting even healthy individuals. The CDC has declared melioidosis endemic to the Gulf Coast, which has raised awareness due to its underreported and underdiagnosed nature.
Perhaps at the danger of too much awareness – a headline in the NY Post “Lethal bacteria could be lurking in your garden” this author finds too alarming. Yet, it is disturbing enough that government authorities want to be prepared. Biomedical Advanced Research and Development Authority (BARDA) has recently stepped in with a multi-million dollar grant for an improved test.
This bacterium causes melioidosis, with symptoms such as fever, chest pain, and pneumonia. Untreated, it can progress to blood poisoning (sepsis). With a caveat about mortality rates in rare diseases sometimes being higher, it can have a mortality rate of up to 50%. That’s increased if the patient has underlying health conditions.
In 2024, five fatalities in Australia highlighted the dangers of this “neglected tropical disease.”
Although most commonly found in Asia and Australia, Burkholderia pseudomallei has been identified in parts of the United States, including Texas, Mississippi, and Georgia. . Experts warn that climate change and extreme weather could further accelerate its spread, making it a growing public health concern in affected regions.
BARDA is part of the US Department of Health and Human Services’ Administration for Strategic Preparedness and Response (ASPR).
The award to Seattle-based InBios International totals $16.5 million and is intended to enable the firm to build on its existing Active Melioidosis Detect Plus device design. The test is a sensitive rapid immunochromatographic strip assay for the qualitative detection of capsular polysaccharide produced by B.pseudomallei and B.mallei. The goal is to finalize the operational workflow and test algorithm. several FDA market authorized and CE marked assays for arboviruses, parasitic infections, biothreats, and more.
PRICE PRESSURE ON TB TEST
We note that there is continued pressure on Cepheid from Doctors Without Borders/Médecins Sans Frontières (MSF) which has been calling for a lower price for Cepheid’s Xpert MTB/RIF Ultra tuberculosis test, and other tests.
This comes as there is good news for Cepheid: The World Health Organization (WHO) has granted prequalification to the Xpert MTB/RIF Ultra, a molecular diagnostic test for tuberculosis (TB), marking the first TB test to meet WHO’s prequalification standards for diagnosis and antibiotic susceptibility testing. Tuberculosis, one of the world’s deadliest infectious diseases, causes over a million deaths annually and places immense burdens on low- and middle-income countries, where early and accurate detection, particularly of drug-resistant strains, remains a critical challenge. Dr. Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products, emphasized this milestone as pivotal in scaling up access to high-quality TB diagnostics that align with WHO’s stringent standards. Prequalification ensures quality, safety, and performance of diagnostic tools, complementing WHO’s endorsement approach, which prioritizes diagnostic accuracy, patient outcomes, accessibility, and equity. The WHO’s decision follows a review of information submitted by the manufacturer, Cepheid Inc., and the regulatory assessment conducted by Singapore’s Health Sciences Authority (HSA).
Danaher last year announced that it would provide the test at cost for $7.97 to the Global Fund to Fight AIDS, TB, and Malaria and to less-developed countries eligible for Cepheid’s Global Access Program. Doctors without Borders wants the company to lower the price to $5 dollars.
The organization has put together a petition with signatures of more than 200,000 people who have endorsed the campaign’s “Time for $5” petition, including healthcare workers, policy advocates, researchers, scientists, and company shareholders.
Editorial note here: Naming prices for IVD can be a perilous business. We are not privy to either Cepheid’s internals or DWB’s calculations, but…what may appear to be a “just” amount of profit may or may not take in all available business factors. For instance, recoups on original investment, marketing, sales commissions and business costs, regulatory and legal work (for instance admin work needed to clear country hurdles or obtain healthcare organization prequalification). A fixed price sets no possibility for future materials sourcing issues, or general inflation.
(also in disclosure: The author is both an IVD industry advocate and a Doctors Without Borders contributor).
Cepheid’s Xpert MTB/RIF Ultra runs on GeneXpert in all of its modules – it detects Mycobacterium tuberculosis as well as resistance to the drug therapy to treat it, rifampicin.
