January 3, 2025 | 2024 was a packed year for diagnostics, starting with the FDA’s final rule amending the agency’s regulations to clarify in vitro diagnostics (IVDs). Companion diagnostics (CDx) also made great strides. Plus: Babson Diagnostics has a new blood testing that does what Theranos claimed to do. Here are the top stories of Diagnostic World News and thoughts from industry leaders. – The Editors
This year, the U.S. Food and Drug Administration (FDA) announced a final rule amending the agency’s regulations to clarify that in vitro diagnostics (IVDs), including tests made by laboratories, are considered medical devices under the Federal Food, Drug, and Cosmetic Act. However, a final rule on laboratory-developed tests has done little to settle the longstanding debate about how Laboratory-Developed Tests (LDTs) ought to be regulated.
Babson Diagnostics has rolled out blood testing that achieves what Theranos claimed to: needle-free, small-volume blood testing, from the convenience of retail pharmacies. David Stein, CEO of Babson, discusses the Theranos comparisons and how his company is making a difference in the diagnostics industry.
Jane Li, senior director of oncology, pharma, and CRO partnerships related to clinical sequencing at Thermo Fisher Scientific, knows that the speed it takes to identify biomarkers of cancer can be a life-or-death matter. Thermo Fisher is helping speed up the diagnostic process with its next-generation sequencing CDx Ion Torrent Genexus System and other platforms.
Companion diagnostics (CDx) have revolutionized cancer treatment by helping improve the safety and tolerability of targeted drugs. To date, there are nearly 180 FDA-approved CDx, but only four are outside of oncology. Jai Pandey, Ph.D., global device regulatory head for in vitro diagnostics and digital health at Sanofi, talks about the “complex business” of CDx development.
Sarcoidosis is difficult to diagnose for a variety of reasons, according to Mary McGowan, CEO of the Foundation for Sarcoidosis Research. With support from the National Institute of Health (NIH), she and her colleagues developed a tool meant to quickly and inexpensively diagnose sarcoidosis.
The Rare Disease Clinical Activity Protocols (RareCAP) is effectively a collection of the latest research-based information and guidance about some of the more than 7,000 conditions affecting a small number of people. The platform aims to standardize the care of rare disease patients in a wide range of settings and accelerate their diagnostic journey, according to Mike Denne, vice president of U.S. medical affairs for rare disease and plasma derived therapies at Takeda.
Community pharmacists will be doing a lot more point-of-care testing (POCT) and be integral members of a patient’s healthcare team, according to Kenneth Hohmeier, Pharm.D., professor and vice chair for education in the department of clinical pharmacy and translational science at the University of Tennessee Health Science Center. U.S. public health could get a big boost by better engaging community pharmacists in providing acute and chronic care services.
Minimal residual disease testing (MRD) has been gaining ground in diagnostics. Panelists at Precision Medicine TriCon 2024 discussed the benefits of MRD, the challenges of keeping momentum, and what needs to be done to overcome said challenges.
Histology has made an art of the complex business of creating high-quality microscope slides. But there are some problems that have prompted efforts in the field to “move things along.” Dozens of newfangled point-of-care (POC) histology techniques have reached such a high degree of maturity that they could soon be in routine use.
Evidence has emerged that indicates low-density lipoprotein (LDL) and high-density lipoprotein (HDL) analytes may be “obsolete” because the famously bad and good guys in standard cholesterol tests provide less useful information about heart health than other lipid molecules circulating in the blood.