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Top Stories of 2022: Post-COVID Diagnostics Market, Pan-Cancer Testing, Afib, Pregnancy

December 29, 2022 | Diagnostics has changed in the past three years with the pandemic necessitating regulatory changes and demanding technical innovation. Some of this change has been directly COVID-related, but much was simply fueled by increased funding and attention to diagnostic problems. This year we watched the results of those changes filter through the industry and spur new thinking.  

Post-COVID Diagnostic Market Shifts: Diagnostics underwent an extreme upheaval during the beginning of the COVID-19 pandemic and the long-term impacts of that are still settling. We looked at several changes to the market. Point-of-care testing—so crucial to rapid response during the pandemic—is poised to explode now that many of the longstanding hurdles have been resolved thanks to pandemic funding and general uptick in adoption.  

Research efforts begun during the pandemic are maturing, hoping to take learnings from the past few years and use them to better prepare for future public health emergencies. For example, a Yale-based diagnostics initiative is building a nationwide network of clinical laboratories embracing an open-source testing protocol for COVID-19 using saliva. The network could be ready to respond to future outbreaks as well, the researchers say.  

NIST’s Role in Future Outbreaks: At the National Institute of Standards and Technology (NIST), researchers have produced a reference material for use as a positive control when developing monkeypox diagnostic tests. Scott Jackson, a microbial geneticist at NIST, explains how the reference material was developed and the changes it signifies for NIST’s role in future outbreaks.  

Pan-Cancer Detection: In a pair of stories, Paul Nicolaus explored the industry’s goals to achieve pan-cancer diagnostic tests and the different technological approaches. The allure of a pan-cancer test, of course, is to easily scan the body for any malignancies, regardless of tissue of origin. Nicolaus explores the efforts of the early leaders in the space and highlights the challenges to both the science and market acceptance.  

Pan-Pathogen Detection: In a similar effort agnostic to tissue-of-origin, Karius’ “liquid biopsy” test looks for microbial cell-free DNA (cfDNA) to accurately identify more than 1,000 pathogens from a single blood draw no matter where the infection may originate. Serious infections, even if deep-seated, release microbial DNA fragments into the plasma. The Karius approach identifies the microbial DNA to choose the appropriate treatment without first having to find it.  

Placental Predictions: Scientists have long recognized that early detection of placental dysfunction increases the chances of a healthy pregnancy but have been unable to anticipate these complications throughout gestation. Researchers at Oregon Health & Science University (OHSU) have created a new magnetic resonance imaging (MRI) technique to quantify placental blood oxygen levels and predict pregnancy complications across gestation.    

Illumina’s Diagnostic Vision: Illumina’s efforts as a company have increasingly included diagnostic tools and development and 2022 was no different. At the JP Morgan Healthcare Conference in January, Illumina CEO Francis deSouza outlined the company’s plans for diagnostics-specific instruments, diagnostics partnerships including with Agendia and Boehringer Ingelheim, and GRAIL.  

Companion Diagnostics: Regulatory efforts around companion diagnostics are rapidly evolving and at the Next-Generation Dx Summit this summer, researchers explored the latest approved companion diagnostics and regulations from FDA and its counterparts in China, Australia, and the European Union (EU).   

Diagnosis by Consumer Device: Finally, the latest in the ongoing race to improve cardiac care via consumer fitness devices, Fitbit’s algorithm to detect abnormal heart rhythms reported a “very high likelihood of being atrial fibrillation [AFib].” Apple’s ECG algorithm, on the other hand, did less well in a different, smaller study. Both companies, among others, are rapidly innovating in the area.

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