JALA Special Issue

The articles in this special issue on the in vitro diagnostics (IVD) industry cover topics relevant to infectious diseases (diagnosis and management of hepatitis C virus [HCV] infection, ¹ sepsis pathogen identification ² ), oncology (microRNAs as breast cancer biomarkers ³ ), neurodegenerative disorders (biomarkers for Alzheimer disease ⁴ ), and prenatal diagnostics (prenatal screening for chromosomal aberrations ⁵ ).

The articles provide background on the different disease states and relevant biomarkers, then discuss technologies for disease screening, diagnosis, prognosis, treatment selection, and treatment monitoring via established and new methods. Some novel biomarkers such as circulating microRNAs are still undergoing validation, while others such as fetal DNA in maternal blood have entered clinical use. Next-generation sequencing is emerging for applications such as microRNA quantification or detection of chromosomal aneuploidies. Matrix-assisted laser desorption ionization time-of-flight (MALDI-TOF) mass spectrometry has entered the clinical laboratory for sepsis pathogen identification, supplementing or replacing traditional microbiological methods. Bead-based immunoassays and array-based PCR enable multiplexed analyte detection for diagnosis of Alzheimer disease and sepsis pathogen identification, respectively. Established technologies may be implemented in new formats, such as a paper-based microfluidic assay to assess liver function relevant for HCV monitoring. Automation is used to increase the throughput of routine immunoassays and nucleic acid testing (e.g., for HCV diagnosis and treatment monitoring).

The articles published in this special issue were prepared by students enrolled at the Keck Graduate Institute (KGI) in the Masters of Biosciences (MBS) program or the Post-Baccalaureate Premedical Certificate (PPC) program. KGI is a member of the Claremont Consortium and has had a strong relationship with the Society for Laboratory Automation and Screening (SLAS) since KGI’s founding class enrolled in 2000. Most KGI students have attended the annual conference, and many KGI graduates are employed by companies that are members of the SLAS community.

The MBS program, a professional science master’s degree, aims to prepare students for careers in the applied life sciences industry, while the PPC program aims to prepare students for medical school. Both programs provide students with a comprehensive introduction to the IVD industry via ALS320–Medical Diagnostics. This required course covers relevant biomarkers, assay development, engineering design, device fabrication, and laboratory automation, in addition to aspects of device regulatory affairs, project management, teamwork, and professional skills. As a main course deliverable, teams of students under the guidance of a faculty adviser write review papers on specific subjects relevant to the IVD industry to acquire in-depth knowledge of a particular topic and refine technical writing skills.

A subset of students from five teams enrolled in ALS320 during the fall of 2013 continued their project beyond conclusion of the course in 2014 as independent study to further expand and refine their team reports into the articles published in this special section. The majority of the final manuscript preparation was carried out by the first two student authors listed on each article, or the first author in the case of the prenatal screening article. We hope that you are impressed with and find value in the student work presented herein.

The students worked closely with their respective faculty advisers (Angelika Niemz or Jim Osborne), who are listed last on each author list and serve as corresponding author. Angelika Niemz received her PhD in chemistry from the University of Massachusetts, followed by a postdoctoral fellowship in chemical engineering at the California Institute of Technology. She joined Keck Graduate Institute in 2002, where she is currently the Arnold and Mable Beckman Professor. Dr. Niemz is the lead instructor of ALS320 and teaches additional courses on medical diagnostics, high-throughput technologies, and instrumentation development. Her research interests focus on developing assays and devices for near patient infectious disease diagnosis.

Jim Osborne received his PhD degree in biochemistry from the University of Maryland Medical School, followed by 12 years as a principal investigator at the National Institutes of Health and 25 years as vice president of Advanced Technology at Beckman Coulter. He joined Keck Graduate Institute in 2007, where he is currently the Robert E. Finnigan Professor and director of the Center for Biomarker Research. He is a coinstructor of ALS320 and teaches other courses on in vitro diagnostics and the molecular basis of disease. His research centers on developing better diagnostic tests for rare diseases.

Angelika Niemz, PhD Arnold and Mable Beckman Professor Keck Graduate Institute Claremont, CA, USA Jim Osborne, PhD Robert E. Finnigan Professor and Director of the Center for Biomarker Research Keck Graduate Institute Claremont, CA, USA