Labcorp Launches New Test for Risk Assessment and Prognosis of Severe Preeclampsia in Pregnant Women

B•R•A•H•M•S™ sFlt-1/PlGF KRYPTOR™ Test System is available through physicians and is the first FDA-cleared biomarker test to aid in the risk assessment of progression to preeclampsia with severe features, a leading cause of maternal and fetal mortality in the U.S. 1 BURLINGTON, N.C. , Jan.

A primary care approach to personalized asthma and allergy management

Enabling better access to kidney disease trials

March is National Kidney Month, and we at Labcorp are committed to improving the renal health of patients worldwide. The field of nephrology clinical research has been steadily adding new interventional trials over the last five years at an average pace of 176 trials per year. This activity reflects the continued interest in and importance of developing new drugs to treat renal disease. The recent approvals of Farxiga® (dapagliflozin) and Kerendia® (finerenone) have also moved the field forward with new treatments to delay kidney disease progression. However, the operational conduct of kidney disease studies—whether they be for chronic kidney disease or rare renal diseases such as IgA nephropathy or focal segmental glomerulosclerosis—remains challenging due to low recruitment rates, a widely competitive geographic spread and long development timelines. Within the Operational Strategy and Development Group at Labcorp, we are deploying various tactics to improve the efficiency of renal studies by focusing on the patient.

Program management services are now offered as part of Labcorp’s Preclinical Oncology Services

When it comes to discoveries in oncology, cancer patients can’t wait, which means neither can you. At Labcorp Preclinical Oncology, we understand there are many steps, phases and regulations to wade through to get to a lead drug candidate—all while time is of the utmost importance.

Alcohol-related liver disease: Inherent challenges and strategies for successful clinical trial conduct

The association between excessive alcohol consumption and liver disease is well documented. In fact, the effect on alcohol consumption levels during the COVID-19 pandemic has more recently been investigated. In a 2022 Hepatology article, researchers estimated that the one-year increase in alcohol consumption during the pandemic would result in an additional 8,000 deaths related to alcohol-associated liver disease (ALD) and 18,700 additional cases of decompensated cirrhosis in the United States alone. Similarly, in the United Kingdom, estimations show there was a 24% increase in the amount of alcohol supermarkets sold in the financial year 2020/2021 compared to the year before. Concurrently, alcohol-specific deaths increased by 20% in 2020, with ALD accounting for just over 80% of those deaths. With the only effective treatment for patients whose liver disease has become irreversible being transplantation, the impact of COVID-19 is significant: in 2021, the British Liver Trust estimated there was a 25% decrease in donors. It is therefore critically important that strategies to slow or halt the progression of this disease are implemented before the patient reaches end-stage liver disease.

What does a central lab do? Four core services

Every clinical trial relies on data from its study participants to inform decisions regarding the safety and efficacy of a potential new treatment. Clinical trial sponsors rely on the data from laboratory tests to bring clear insights that advance studies.

How to de-risk OECD 443 studies through optimized dose level selections

The European Chemicals Agency (ECHA) recently conducted a review project regarding the design of the OECD 443 (Extended One-Generation Reproductive Toxicity Study, or EOGRTS). The project’s goal was to assess the performance of the study in terms of study design, conduct and findings to determine if the study design currently prescribed gives sufficient information for regulatory hazard classification.

Integrating technologies: Ultrasound and cfDNA screening in twin pregnancies

Despite overall limited data on cell-free DNA (cfDNA) testing in twin gestations, MaterniT 21 PLUS has demonstrated high sensitivity and specificity in screening for trisomy 21 in twins from the first trimester of pregnancy (comparable to that observed in singleton pregnancies), as well as promising performance in screening for trisomies 13 and 18, according to the results of a newly published study.1 Hear from our experts about the nuances of twin pregnancy care as we combine ultrasound expertise with the latest research review on fetal cfDNA screening.

Top considerations for developing a biomarker solution and CDx strategy

When it comes to designing clinical trials with expedience and efficiency, many drug developers are choosing biomarker-driven strategies for their investigational precision medicines. As key features of developing new therapies and diagnostics, biomarkers define the disease biology, provide potential targets for new therapies and provide strong potential for market differentiation. When considered together with companion diagnostic (CDx) development, biomarkers also offer relevant clinical information that may bring deeper insights, enabling breakthroughs in various precision medicines. At the 2022 Japan Symposia, Mark Roberts, senior director of diagnostic development services, weighed in on ways drug developers can examine their biomarker and CDx strategies and enhance outcomes for their programs.