“Arbitrary and capricious” is what the College of American Pathologists (CAP) has called the process of deciding to regulate lab-developed tests that the FDA took on earlier this year. This in a strongly-worded amicus brief filed on October 7, 2024.
CAP argued that the FDA’s new rule, which classifies LDTs as medical devices, places unreasonable restrictions and significant compliance costs on laboratories. CAP raised concerns that the regulation could delay critical disease diagnoses and negatively impact patient care.
CAP President, Dr. Donald Karcher, expressed the growing concern among pathologists, who now face difficult decisions about the availability of LDTs in their communities. The amicus brief criticized the FDA for failing to address the negative consequences of its regulatory approach, warning that it could stifle innovation and limit access to vital diagnostic tests. CAP called on the U.S. District Court for the Eastern District of Texas to vacate the rule, describing the FDA’s actions as arbitrary and capricious.
This case underscores the high stakes involved in regulating LDTs, which have been crucial for diagnosing diseases in clinical settings. CAP’s involvement highlights the potential risks the regulation poses to healthcare professionals and their ability to provide timely, accurate diagnoses to patients.
CAP says “Costs will significantly burden laboratories, making it unacceptably expensive for them to continue to develop essential and innovative LDTs, resulting in depriving patients of these life-saving tests. The following are some examples:
Immunohistochemical stains used by pathologists in diagnosing and classifying most cancers
- Epidermal growth factor receptor (EGFR) tests used to determine whether a patient with non-small cell lung cancer could benefit from targeted tyrosine kinase inhibitor (TKI) therapy
More Than Half Sepsis Patients Die Within Two Years: But Why?
A new study has found that more than half of patients diagnosed with sepsis, also known as blood poisoning, die within two years. And it’s getting a fair share of media attention. But what it cannot conclude is if the sepsis event caused it, or if sepsis patients just tend to be in poor health.
Conducted by Danish researchers, the study revealed that 50% of patients admitted to emergency rooms with sepsis died during a median follow-up period of two years. Sepsis, a severe condition triggered by the body’s response to infection, continues to pose a significant long-term health risk.
The study identified several factors that increase the likelihood of death following sepsis, including advanced age and pre-existing conditions such as heart disease, cancer, and dementia. Finn Nielsen, senior scientist at Aarhus University Hospital, noted that these underlying health issues further complicate the outcomes of sepsis, with prior hospitalizations for sepsis also elevating the risk.
The findings emphasize the importance of early detection and treatment to improve survival rates. The study highlights the ongoing battle against sepsis and underscores the need for healthcare systems to focus on mitigating its long-term impacts through comprehensive care strategies.
Speaking of Sepsis,
“Give me the next step I need to take, even without a diagnosis.” to paraphrase the request of one provider to IVD companies making tests. Good coverage in CAP Today’s September issue is worth a visit if you haven’t yet read – https://www.captodayonline.com/host-response-solutions-to-sepsis-risk-prediction/ It deals with approaches to sepsis: In the emergency department, rapid decision-making is critical for patients suspected of having sepsis. According to Dr. Chadd Kraus of Lehigh Valley Health Network, the focus in the first few minutes is not necessarily identifying the exact pathogen but determining how severe the infection is and what interventions are needed. For Dr. Kraus, a “good test” is one that helps guide the next step in patient care, rather than delivering a definitive diagnosis. Dr. Ledeboer, a professor of pathology at the Medical College of Wisconsin, highlighted current and upcoming technologies that could enhance sepsis detection by analyzing host response biomarkers. These advancements could help emergency physicians make more informed decisions about patient care in critical early moments.
B12: New Test
Cobalamin (Vitamin B12) is primarily found in animal-based foods such as meat, fish, dairy, and eggs, and is also available in fortified plant-based products like cereals and nutritional yeast. Vegans, vegetarians, and those with absorption issues may need to rely on supplements or fortified foods to meet their B12 needs. It is essential for the production of red blood cells, DNA synthesis, and the proper functioning of the nervous system.
A deficiency in B12 can lead to a variety of health issues, including megaloblastic anemia, where red blood cells are enlarged and cannot function properly, causing fatigue and weakness. B12 deficiency can also result in neurological problems such as numbness, tingling, balance issues, memory loss, and cognitive decline. If left untreated, these symptoms can become severe and lead to long-term nerve damage.
BioMérieux announced recently that it obtained the CE mark for its Vitamin B12 Total assay, which will be available on the firm’s Vidas immunoanalytical platform. This new test is designed to measure total B12 levels in blood serum or plasma, helping diagnose B12 deficiency. Conditions like anemia and neurological impairments, including cognitive issues and walking difficulties, are often associated with low B12 levels. The addition of this assay completes BioMérieux’s comprehensive lineup of anemia-related tests on the Vidas system.
The Vidas platform, a core product in BioMérieux’s immunoassay strategy for decades, offers both high-throughput and modular testing options. Jennifer Zinn, executive vice president of clinical operations at BioMérieux, emphasized that the new B12 assay complements the existing Vidas portfolio, which spans infectious diseases, emergency, and critical care diagnostics. The Vidas system allows labs to deliver rapid, actionable results for patient care.
The Vitamin B12 Total assay is expected to launch in select countries by the end of 2024, with a broader rollout planned for early 2025. This addition underscores BioMérieux’s commitment to expanding diagnostic tools for better patient outcomes.
