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Most-Read Stories on 360Dx in 2023: FDA LDT Plans, Layoffs, Technology Development

NEW YORK – With COVID-19 now firmly entrenched in the daily lives of people around the world, the in vitro diagnostics space pivoted away from a seemingly endless number of firms developing new tests for the infection and at times appeared stagnant in 2023 compared to the prior few years.

Regardless, there was no shortage of news in the diagnostics space as firms continued developing new assays and platforms to tackle ongoing and emerging diseases. As always, 360Dx readers remained curious about technology development in the IVD space, particularly as COVID cases declined and firms reimagined their test development approaches.

The most-read story for the year, however, was not about a shiny new technology but rather about Roche's plans to bring a fully automated mass spectrometry-based clinical analyzer to market in 2024. Roche's plans will have its challenges, though, as it follows recent similar moves by Danaher's Sciex and Thermo Fisher Scientific, whose clinical mass spec instruments failed to gain commercial traction.

On the regulatory front, everything old was new again in 2023 as the US Food and Drug Administration once again moved to codify what it sees as its already-established power to regulate laboratory-developed tests. Many in the lab industry said the agency is misguided, however, setting up again a legislative, public relations, and probably legal battle ahead.

The past year also was fraught with economic headwinds, and many firms were forced to trim their payrolls or restructure their operations in other ways, while other companies shuttered. Stories about the industry's difficulties consistently landed near the top of 360Dx's most popular stories throughout the year, and readers found particular interest in a story about a highflier in the early days of the pandemic, Cue Health, which has had a rough time finding its footing as the health crisis waned.

Lastly, as is the case every year, 2023 started with the JP Morgan Healthcare Conference, providing plenty of news from firms throughout the biotech industry and attracting significant reader interest in companies' plans for the coming year. 

Below are the 10 stories that 360Dx readers found the most compelling for the year that just wrapped up.

1) Roche Planning 2024 Launch of Automated Mass Spec Clinical Analyzer

2) FDA Approves Foundation Medicine CDx for Use With Janssen Drug in Prostate Cancer Patients

3) FDA Resumes Move to Regulate LDTs, Likely Setting up Legal Battle With Lab Industry

4) JP Morgan Healthcare Conference, Day 1: Guardant Health, Exact Sciences, QuidelOrtho, More

5) Abbott Laboratories, Beckman Coulter, Siemens Healthineers, Roche Gain FDA Clearances in July

6) Diagnostic Companies Aim to Bring Routine Testing to Point of Care, but Face Significant Hurdles

7) Cue Health Implements Cost Reduction Plan, Lays off 326 Employees

8) FDA Releases Proposed Rule for Oversight of Laboratory-Developed Tests

9) BioMérieux SpotFire MDx System Leverages Novel Approaches for POC Market

10) Quest Diagnostics Addresses Acquisitions, Reimbursements, Testing Landscape at JP Morgan