BioPharma

Mayo Clinic Laboratories’ BioPharma Diagnostics team facilitates specimen collections and access to archived samples to support clinical trials and diagnostic validation projects that advance healthcare. In this collaboration example, learn how BioPharma Diagnostics helped a research healthcare company evaluate the clinical performance of three assays designed to aid in the diagnosis of Alzheimer’s disease and other causes of cognitive impairment.

Mayo Clinic Laboratories’ BioPharma Diagnostics team supports companies from discovery to post-market in advancing their precision medicine initiatives. In this collaboration example, learn how BioPharma Diagnostics helped a biotech company complete a surveillance biomarker study to establish a cutoff for its assay developed to monitor the progression or regression of disease in patients with well-defined gastroenteropancreatic neuroendocrine tumors (GEP-NETs).

An ideal testing partner will offer extensive expertise in assay development and analytical validation services, along with access to biospecimens. In this collaboration example, learn how Mayo Clinic Laboratories’ BioPharma Diagnostics team helped a musculoskeletal diagnostics company complete a prospective study to demonstrate its test’s performance in detecting periprosthetic joint infection (PJI) in synovial fluid.

Paul Jannetto, Ph.D., explains the advantages that Mayo Clinic Laboratories' oral fluid drug screening offers over typical urine tests. Oral samples are easier to collect and harder to adulterate.

Mayo Clinic Laboratories’ BioPharma Diagnostics team collaborates with biopharmaceutical, diagnostic, and other research companies to offer a wide range of laboratory testing and biopharma support for all phases of clinical trials. In this collaboration example, learn how BioPharma Diagnostics helped an international diagnostics company complete a study of patients with liver cirrhosis with the goal of validating a specific serum metabolite constellation to detect early hepatocellular carcinoma (HCC) lesions in liver cirrhosis.

Mayo Clinic Laboratories has marked a significant advancement in the fight against Alzheimer's disease with the introduction of an innovative diagnostic test. This noninvasive blood test accurately detects the p-Tau217 biomarker, indicative of amyloid beta accumulation in the brain. This test is set to transform the approach to Alzheimer's disease management, offering a convenient and less invasive alternative to traditional diagnostic methods.

Maria Alice Willrich, Ph.D., explains how Mayo Clinic Laboratories' new assay provides therapeutic drug monitoring of risankizumab, or RISA. Test results help guide care for patients with plaque psoriasis, psoriatic arthritis, and Crohn's disease.

Mayo Clinic Laboratories introduces an advancement in the management of Crohn's disease with the release of a new laboratory test that measures Risankizumab levels in patients. This test will advance the therapeutic monitoring of Crohn's disease, enabling personalized treatment approaches.

Alicia Algeciras-Schimnich, Ph.D., discusses Mayo Clinic Laboratories’ new noninvasive plasma biomarker assay for Alzheimer’s disease, an accessible, highly accurate testing option for individuals age 50 and above who are experiencing mild cognitive impairment or early dementia. Positive test results can confirm amyloid beta pathology and facilitate access to disease-modifying therapies.

BioPharma Diagnostics executives will attend the 12th Annual Alzheimer’s & Parkinson’s Drug Development Summit, set to take place in Boston, Massachusetts, from April 23 –25. They will be available to meet with attendees to discuss how our capabilities and data can accelerate biopharmaceutical and clinical research initiatives.

Ann Moyer, M.D., Ph.D., explains how Mayo Clinic Laboratories' test panel provides comprehensive evaluation of patients with suspected monogenic early onset inflammatory bowel disease, or IBD. Accurate diagnosis is key to guiding therapy for patients, who might be as young as 2 years of age.

On the brink of losing her battle with acute myeloid leukemia, Shannon Camlek arrived at Mayo Clinic as a last hope. Her chances didn’t look good, but with the help of specialized genetic testing, particularly FISH (fluorescence in situ hybridization) studies, doctors were able to detect the specific gene mutations responsible for her symptoms and disease. The test results also helped Shannon’s care team target her treatment accordingly, and finally put an end to what Shannon likens as starring in her own personal horror movie while in search of hope and healing.

Mayo Clinic Laboratories is excited to participate in the 65th ASH Annual Meeting & Exposition, which will take place in San Diego on Dec. 9–12, 2023.