Author: Bruce Carlson

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…

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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…

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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…

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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…

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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.But first – we wanted to highlight our EYE ON IVD End of The Year Sale on All of Our Market Research, w/Discounts up to 20%. Visit our Research Shop Now for details: https://eyeonivd.com/research-report-shop/Lab-in-a-box systems, ranging in size from a printer to a refrigerator, were once the stuff of talk, but have since made progress in development. This according to Eye on IVD’s “Very Cutting-Edge…

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On December 4th, Eye On IVD consulted three IVD industry experts to talk about less than notable trends. We have received many requests for our webinar for those who were not able to make the live presentation or would like to re-hear it. Please find below our Very Cutting-Edge Trends IVD Webinar in video and transcript format:Webinar Participants:Rob Lacroix, LTC LLCFrank Criscione, Broadbranch AdvisorsDavid Freestone, BridgeworXBruce Carlson, Eye On IVDA transcript is available below. We note that it is an AI-generated sound transcript of the webinar, and thus there may be some imperfections; best to listen to the webinar video…

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According to Siemens, nearly 49% of patients with elevated troponin I levels may experience a major adverse cardiac event or death within the year. For this reason, Siemens Healthineers has been highlighting the FDA clearance of a new prognostic indication for its Atellica IM high-sensitivity troponin I (TnIH) test. The blood test helps healthcare providers identify patients at risk of death or major cardiac events within one year after presenting to the emergency department (ED) with acute coronary syndrome symptoms.Cardiac troponin I is a biomarker for heart muscle injury.Siemens in a press release featured the use of the marker by…

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Billions of dollars will be earned by companies who can develop tests that improve the diagnosis of viral, bacterial, fungal and other disease threats. The only question is which companies? Will it be the existing leaders in the field, like Abbott, Roche and biomerieux? or will new competitors emerge. The history of IVD would seem to point to an answer. New companies, able to innovate faster, will share in the revenue. What is that revenue? Last week, Eye On IVD’s webinar detailed the market for infectious diseases with an eye to 2035. Of all IVD market categories, the webinar stated,…

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With the reduction of COVID-19 testing and companies starting to recover testing revenues, there has been a tendency to say: we are back to 2019 levels. In an upcoming webinar this Wednesday, EYE on IVD we will dispute this, we will make the case that the in vitro diagnostic market for infectious diseases is not merely “back to the pre-COVID-19 era.” While there has been a reduction in testing for COVID-19, particularly asymptomatic testing that characterized a few years ago, there are longer-term changes that make this new era different because of what the healthcare system experienced during the pandemic.We…

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hird quarter results are in at some the major in vitro diagnostic test companies. The market for IVD tests beyond COVID-19 is expanding. Companies are boosting their chemistry, immunoassay, traditional infectious disease business, their “core” businesses. This is evident. When exclusions are made and context is given, there are some positive results.But the amount of growth is not particularly exciting, and there are some declines from 2023.Starting with: Abbott’s diagnostic business declined overall, a slight revenue decline to $2.41 billion Q3 2024 from $2.45 billion Q3 2023. Once COVID-related testing is excluded, the news is brighter. Abbott Rapid Diagnostics, absent…

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