When a patient has a rare disease, it can take months or even years to reach the correct diagnosis. For the more than 30 million people in the United States who have been diagnosed with a rare disease, many relied on tests from highly specialized laboratories to finally provide answers.
That was the case for a 3-month-old girl whose parents brought her to the hospital after noticing a hernia. Puzzling symptoms, including enlarged kidneys and high blood pressure led to multiple diagnoses of chronic kidney disease. Yet, doctors couldn’t determine why her kidneys were failing.
A year later, when she became less responsive to treatment, her physicians ordered additional blood tests. The results pointed to a different diagnosis and a new treatment path. But when that treatment also began to fail, doctors suspected they had finally identified the underlying cause. To confirm it, they needed a rare and complex test: the hemolytic CH50 complement test.
Exsera BioLabs, a reference lab located on the University of Colorado Anschutz Medical Campus that is integrated into the CU Department of Medicine’s Division of Rheumatology, specializes in advanced diagnostics like the hemolytic CH50 complement test and plays a critical role in diagnosing rare conditions. They also support pharmaceutical companies by testing samples in clinical trials, helping verify the efficacy of a drug being submitted to the Food and Drug Administration (FDA) for drug approval.
Ashley Frazer-Abel, PhD, DABMLI, director of Exsera BioLabs and an associate professor in the Division of Rheumatology, remembers the moment her lab provided the answers that changed this child’s life.
“For her disease, the only treatment used to be a kidney transplant. But because her condition is an immunology issue — not a kidney issue — a transplant would eventually fail,” Frazer-Abel says. “Exsera was able to perform the needed test and also participate in clinical trials that helped bring a drug to market which now prevents kidney failure in these children. That’s what excites me about this work. I get to help diagnose patients and contribute to treatments that help them survive.”
This is just one example of the impact Exsera delivers. Now, Frazer-Abel and Vijayalakshmi (Viji) Nandakumar, PhD, DABCC, associate director of Exsera BioLabs and an assistant professor in the Division of Rheumatology, have ambitious plans to grow Exsera BioLabs into a regional powerhouse and a leading reference laboratory in the nation.
Exsera BioLabs has expanded exponentially over the past decade, growing from a small team of four to a multidisciplinary group of more than 25. This growth has not only increased capacity but also brought in specialized talent to elevate the lab’s clinical and scientific impact, especially in the field of autoimmune disease.
A pivotal part of that growth came in August 2024 with the addition of Nandakumar. She brings a strong background in immunology research and laboratory medicine from two of the nation’s leading academic reference laboratories, Mayo Clinic and ARUP Laboratories. With deep expertise in clinical diagnostics, regulatory compliance, and clinical consultation, Nandakumar has focused on strengthening Exsera’s infrastructure, enhancing quality systems, and driving expansion into new diagnostic frontiers.
Over the past year alone, Exsera BioLabs underwent several major transformations. The lab moved into a brand-new, expanded space, modernized lab systems, and doubled down on automation, leading to a reduction in average turnaround time to four days — even for larger, more comprehensive tests — while significantly strengthening their quality and test validation processes.
“Our vision is that clinicians shouldn’t have to send out routine or even specialized tests to outside labs,” Nandakumar says. “They should be able to send them right across the street. We want to match — or exceed — the standards of national reference labs in both quality and turnaround time.”
With this growth, the lab is now pushing forward into autoimmune and esoteric testing — areas where demand is high, but access is limited. According to Nandakumar, the potential for growth in autoimmune diagnostics is significant.
“We have a large complement test menu that other reference labs don't offer,” Nandakumar says. “But a lot of autoimmune tests are still being sent to labs outside of our campus, so there's a clear opportunity for us there. We’re also looking into developing more esoteric testing that only few reference labs provide, such as the myositis panel.”
To conduct autoimmune tests, scientists will analyze blood panels to detect markers of diseases like lupus or rheumatoid arthritis. Esoteric tests go a step beyond routine screenings by measuring rare or complex biomarkers critical to diagnosing uncommon conditions. The myositis panel, for instance, can detect antibodies linked to a group of rare autoimmune diseases that cause muscle inflammation — affecting roughly 75,000 people in the U.S.
“We have several autoimmune and esoteric tests in the pipeline,” Nadakumar says. “Very few laboratories offer both conventional and esoteric autoimmune testing under one roof. At Exsera, we aim to change that — our menu could become one of the most comprehensive in the country.”
This innovation matches what is already being offered through Exsera BioLabs’ complement testing.
“Most of the tests on the complement side that we do here are niche, rare, and a lot of them are laboratory-developed tests that are only run here,” Frazer-Abel says.
These custom-developed diagnostics also support clinical trials for pharmaceutical and biotech companies. Today, Exsera serves over 100 individual clients and supports more than 80 ongoing clinical trials—many of which are pivotal trials, meaning the data is submitted directly to the FDA as part of drug approval applications.
“We test samples for industry clients and provide quality data that’s submitted as part of their FDA approval packages,” Frazer-Abel says. “That work positions us as not just a clinical reference lab, but also a contract research organization. It shows the diversity of science and impact we have on this campus and demonstraties the full pathway from discovery to approved treatment.”
Beyond developing tests, Frazer-Abel and Nandakumar are focused on creating integrated panels that combine multiple diagnostics into a single, streamlined tool for clinicians.
“If you think about lupus, we could combine a complement test, an autoimmune test, and some inflammatory markers in one panel,” Nandakumar says. “Clinicians would benefit from being able to order these with the click of a button and receive high-quality interpretation. Having that under one roof would make a huge difference.”
High-quality interpretation is a core part of Exsera’s work and something they aim to expand with their growing test offerings. While their primary focus is on autoimmune and complement diagnostics, both Dr. Nandakumar and Dr. Frazer-Abel are well-versed and equipped to extend their expertise into other areas of diagnostic immunology. Since Frazer-Abel and Nandakumar hold leadership roles in national and international lab medicine and regulatory organizations, they’re also able to stay connected to the latest diagnostic innovations and regulatory changes.
This ability to pair clinical insight and lab expertise is part of what makes Exsera unique. By offering these tests on the Anschutz campus, experts at Exsera can be more integrated with care teams to provide a deeper understanding of the test results. Frazer-Abel and Nandakumar emphasize that their collaboration with physicians in turn enhances their diagnostic offerings and leads to better patient care.
“We have the expertise to build tests from the ground up,” Frazer-Abel says. “If someone on campus has a biomarker they want to test, we have the expertise to make it regulatorily compliant and can work with the physicians to get it clinically validated.”
Nandakumar agrees and sees the partnership with the university and clinicians as a two-way street, and essential for their continued growth.
“Being in an academic setting gives us a huge advantage,” Nandakumar says. “The constant back and forth with clinicians shapes our priorities. So being integrated within the Division of Rheumatology helps us stay aligned with the evolving clinical needs and ultimately deliver better patient care.”