Leverage the experience and insights of regulatory experts, scientists, analytical chemists and data modellers to build weight of evidence arguments supporting your substance’s ED profile. By taking an integrated approach, Labcorp can make scientific arguments that stand up to regulatory scrutiny. Find out more about the comprehensive support on offer here:
Labcorp can partner with you in a flexible way to help clarify and address your needs. With ED testing insight gained from multiple EU and US submissions, our experts can leverage their knowledge to support you. Whether you need scientific guidance on an ED testing strategy or simply a set of ED tests run to high standards, we can help. Click the link below to explore our ED testing capabilities and how they can be utilized for all global regulators:
ED screening tests can be challenging to conduct and interpret. Regulatory endpoints vary between regulators and are constantly evolving. To optimize the value and efficiency of your testing program you need high levels of technical expertise and excellent scientific insight. Informed study design maximizes the value of your data and reduces redundancy in your ED testing program. Labcorp helps you craft coherent arguments that win over regulators.
A major challenge in ED testing is the accurate measurement of thyroid hormones levels at very low concentrations. Many ED assays require the measurement of serum thyroid hormones T3 and T4 in fetuses or pups. In such young animals, thyroid hormone levels may be in the low pg/mL level. This is at the detection limits of standard analytical approaches, which undermines the reliability of your test results. You need a partner who has this capability to measure such low levels. Labcorp has pioneered an in-house method that is sensitive and accurate for assessing thyroid hormones T3 and T4 down to low pg/mL concentrations. The technique involves the use of UHPLC-MS/MS and it has been widely applied to a range of OECD and EPA studies requiring thyroid function assessment. This overcomes a common barrier to ED screening by providing reliable and verifiable thyroid hormone results. Labcorp can offer this innovative and industry-leading technique to our partners.
To interpret the results from ED tests effectively you need to compare them to control data. The optimum comparator is to historic data gathered over years. For some new endpoints, like thyroid hormone levels, such historic data may not be available or may be unreliable. Labcorp started working in endocrine disruptor testing in the 1990s. This has enabled us to build expertise, insight, techniques and historic data sets that you can benefit from. Our historic data sets are especially important for thyroid hormone assays and reflect our innovation in this area of ED testing.
