Author: Bruce Carlson
https://www.youtube.com/watch?v=kBV6sE24omM&t=1058sMost IVDs are commodity tests, and growth of value and scope is the way to counter that, said Greg Powell, of Howe Sound research (an IVD market research company) on a recent webinar. Greg is the lead author of a 540-page market research study (Available for order on EYE ON IVD: ARTIFICIAL INTELLIGENCE IN IVD MARKETS – Eye On IVD ). He discussed his findings on a recent webinar. Value and scope drives price and that drives IVD profits, Powell said. And the reason AI is essential to seeing better-than-average growth rates in IVD instead of low ones is because…
The federal employee firings in the news have landed on a possible impact area for in vitro diagnostics, with reports of layoffs at FDA and more specifically, at CDRH. The Center for Devices and Radiological Health (CDRH) regulates IVDs, also imaging and other devices, as well as software.The effects of the layoffs of probationary employees on the in vitro diagnostics industry are unclear, but fewer employees at the agency should, logic must portend, increase review times and thus decrease clearance time. That is, unless other regulations are changed or applications are fast-tracked through a yet-to-be-announced policy. So far, only the…
Increasingly, using other companies to perform manufacturing work has become common in in vitro diagnostics. That would not have been the case two decades ago. With the amount of tests that are coming, there will need to be even more. That’s the point of our most recent webinar on Contract Manufacturing, check it out here: The webinar can only go into so much detail For more numbers and data, our report is available: CONTRACT MANUFACTURING IN IVD MARKETS – Eye On IVD
The announcement that Franklin Lakes, NJ-based Becton Dickinson is going to spin off its diagnostics (and life sci) unit and concentrate on medical technology made news this week. While we didn’t prognosticate it, it’s not surprising. Becton Dickinson (BD) is into a lot. It’s huge in specimen handling, both in volume and innovation. It’s a leader in microbiology, which let’s face it, could be a whole company in and of itself, given the needs there. It offers advanced patient management systems, and flow cytometry. And that’s only part of it.Now, It’s chosen to form a “New BD” that will focus…
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OK, we are paraphrasing here. But if you look at the recent approvals, you see in vitro diagnostic test makers saying it, adopting an approach of let’s test for what can best help providers. Don’t get their intentions wrong, they plan to sell the big comprehensive tests too. But what they are pushing is testing for the important.Case in point: Inflammatix, more or less is saying “We got to stop thinking about sepsis as a disease.” We have to stop ruling it “in,” or ruling it “out.” Now I am paraphrasing, but this is the war-weary cry of many providers…
Developments in artificial intelligence and in vitro diagnostics including: regulations, new products, and expert viewpoints are constant. Here we list some notable links in AI and IVD we are tracking. TEMPUS AI WILL BUY AMBRY: Tempus AI has announced an agreement to acquire Ambry Genetics for $375 million in cash and $225 million in shares. Ambry is Tempus’ primary reference lab. The deal will combine Ambry’s extensive genetic testing capabilities with its AI-driven data analytics platform. [READ MORE] https://www.cooley.com/news/coverage/2024/2024-11-04-tempus-announces-$600-million-acquisition-of-ambry-genetics ROCHE BETS ON AI-DRIVEN PATHOLOGY: Roche announced it had integrated over 20 AI algorithms from eight collaborators into its digital pathology…
It would be a stretch to say the J.P. Morgan Healthcare Conference is an in vitro diagnostics meeting. Healthcare IT and pharmaceutical deals traditionally dominate the handshakes there, and that’s no exception this year. Heck, one pharma deal announced at JPM would equal a seventh of the entire IVD market, just one deal. But we aren’t bitter.In fact, IVD is always represented at JPM, and investors have always been interested; particularly in companion packages and novel tech.So far, a few nuggets are worth reporting that might be of interest to IVD watchers:Roche Sees Mid to High Single-Digit Diagnostics Growth: -Roche…
Lab-developed tests, lab consolidation and infectious disease threats dominated the news relative to in vitro diagnostic (IVD) companies in 2024, Eye On IVD notes. Other stories, such as rising fungal infections and studies have not been as but are just as important. These stories have been covered by our Linked In newsletter and our email (subscribe at eye on IVD.com).Eye On IVD notes the following stories:TOP STORY: FDA Lab-Developed Test PolicyIt should be no surprise that the top story of 2024 in the laboratory industry, spilling over into the IVD supplier industry, is the FDA’s change in approach regarding lab-developed…
A TALE OF 137 TERABYTES: WEBINAR TALKS ABOUT DATA OPPORTUNITY IN IVD THANKS TO WEARABLES AND AIImagine 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…