Phthisis Diagnostics develops innovative molecular diagnostics products

Nov. 18, 2012

Our mission is to improve human health. “Phthisis” (tye-sis) is the Greek term for tuberculosis, an infectious disease still very much a problem in the modern world. Phthisis Diagnostics is a research and development company founded with a mission to develop easy-to-use, cost effective molecular diagnostics with a focus on diseases of public health importance and to facilitate clinical adoption of modern diagnostics. Ultimately our mission will lead to improved human health. We work with biotechnology companies and clinical diagnostic labs to develop innovative molecular diagnostic products. We also work with academic research and environmental testing laboratories to adapt our products for use in these settings.

Crystal Icenhour
President and Chief Science Officer

President and Chief Science Officer of Phthisis Diagnostics since 2006; prior to that, Research Associate in the Department of Molecular Genetics and Microbiology at Duke University Medical Center; consultant at Duke as an Adjunct Assistant Professor in the Department of Medicine, Division of Infectious Disease;recognized as a 2012 Ewing Marion Kauffman Foundation Outstanding Postdoctoral Entrepreneur.

BS, University of Tulsa Department of Biological Sciences; PhD, University of Cincinnati Medical School of Graduate Studies in Pathobiology and Molecular Medicine; Postdoctoral fellowship in the Thoracic Diseases Research Unit at the Mayo Clinic College of Medicine.

I am a member of the Charlottesville Business Innovation Council; sit on the board of the Virginia BIO; have memberships in several professional associations; and serve as vice chair for the Pastoral Advisory Council at Saints Peter & Paul Catholic Church. My husband, two children, and I share an interest in karate, including competitions. We also enjoy hiking and other outdoor activities with our dogs.


Products and solutions have evolved to meet changing customer needs. We set out to develop a line of molecular diagnostic products, but soon found that the initial extraction process was an unpleasant and time- consuming chore for laboratory technologists. We took a slight detour from our original game plan to first develop a high quality DNA/RNA extraction process that takes less time and yields a higher quality result. Our E-Sphere® Simple NA Kit answers that challenge.

We know that clinical laboratories face the challenge of obtaining consistent and reliable controls to monitor the performance of molecular assays and instruments, so we have just launched a new product line, the G-Sphere® Molecular Standards. These products are synthetic genes that provide stable, consistent and abundant controls for virtually any organism and for virtually any molecular assay. In addition to a product line, we’re also capable of developing customized standards to meet a lab’s particular need. This product line is so economical that it will be useful for personnel training and for assay development. These standards are versatile and made of non-hazardous material, so safety and disposal concerns are minimal.

E-Sphere Simple NA Kit represents a breakthrough in nucleic acid extraction. The E-Sphere Simple NA Kit is a novel, streamlined extraction process that is easier to use and faster and provides better results compared with traditional methods that involve beads, silica, binding, washing, and eluting. Our simplified process involves only four steps and just two sample transfers, reducing the possibility of contamination and increasing safety for the technician. With our unique process, 12 samples can be purified in less than 30 minutes. The product is packaged to maximize efficiency and reduce waste for labs. This built-in efficiency means significant cost savings for labs and throughout the healthcare system. Most important, patients can benefit from faster diagnosis and effective, targeted treatment that can mean the difference between life and death.

Phthisis recently announced its first European and Asian international distribution agreements. We’re very excited that we’ve now signed several international distribution agreements in Latin America, Europe, and Asia, with more in negotiations. We are currently preparing our first diagnostic product, R-SphereCGE Detect, for clinical trials and plan to push it out quickly into the U.S. market once we get FDA approval. In the meantime, we don’t need FDA approval to sell our E-Sphere Simple NA Kit or G-Sphere Molecular Standards in international markets. Additionally, we can sell the R-Sphere CGE Detect abroad with a CE Mark, which requires a less complex regulatory approval. Not only will we generate revenues to support the company, but we’ll also be able to collect additional data about the products and feedback from users before they hit the U.S. market. This strategy is beneficial for both Phthisis and the industry as we introduce our technologies into the marketplace more efficiently.

The importance of nurturing a positive example for the next generation of scientists. Phthisis periodically hosts technology tours for high school students interested in a career in biomedical sciences. During tours of our facility, students have a chance to talk with our scientists and to participate in hands-on demonstrations. Additionally, each year Phthisis scientists donate a day serving as judges in local science fairs. I have served on the board and as chair of the National Postdoctoral Association and have directly mentored a number of researchers over the years. Recently, I was appointed to serve on the advisory board for the Health and Medical Sciences Academy at Monticello High School. All of these activities give back to the local and scientific communities, setting a positive example for a new generation of innovators.

How a scientist can channel his or her expertise into the clinical sphere. While I certainly appreciate the value of basic research, I have learned that I am most personally fulfilled through research that leads to products that directly impact people’s health. Perhaps some of that pragmatism came from growing up in a family that owned a small business in Arkansas. Helping out and hearing conversation at the dinner table taught me what it takes to run a business and also helped form my entrepreneurial bent. That was a very different business from what I’m doing now, but I learned an important philosophy: you see a problem, you create a solution, and then you run the company. It seemed natural for me to follow an entrepreneurial path to creating pragmatic tools to fight disease, to apply my science background to creating direct results that will benefit patients right away.

For healthcare to improve, basic science must be translated to fit the needs of the clinical sphere. A growing need for “scientific translators” exists; a need for scientists cross-trained between basic science, clinical science, patient care, and product development. Such training will facilitate improvement in public health and the human condition.