- Inside UNM
New Mexico-based start-up company P.D. Laboratories recently signed an option agreement with STC.UNM, the University of New Mexico's technology transfer office to license technology developed by UNM faculty members Sang Han, professor in the departments of Nuclear and Chemical Engineering and Electrical and Computer Engineering, and Mani Hossein-Zedah, assistant professor in the department of Electrical & Computer Engineering.
The company will develop two technologies for separating and detecting protein biomarkers in blood for the presence of heart, cancer and infectious diseases. The first device will be able to purify and concentrate protein biomarkers from blood samples. The technology from the first device will then be incorporated into a second handheld device, called Diagnose.IT, which will be able to detect and measure multiple biomarkers simultaneously.
The company is the creation of co-founders Joaquin Duran and Harry Pappas. Duran, P.D. Laboratories CEO, formerly served as the Operations Manager for Bostran 21 S.L., an HVAC engineering company specializing in mobile climate modular systems. He holds an M.S. in Industrial Management Engineering and an M.B.A. from UNM's Anderson School of Management. Pappas, company COO, has experience in the pharmaceutical (Vertex Pharmaceuticals) and microfluidics (Caliper Life Sciences) industries and is a biomedical researcher. He holds an M.S. in Nanoscience & Microsystems with a concentration in technological entrepreneurship from UNM's School of Engineering and is pursuing his doctorate in the program.
Han and Hossein-Zadeh will share the position of Scientific Advisers to the company and direct its research and development. P.D. Laboratories hopes to capitalize on the biomarker detection market, currently exceeding $8 billion annually with a growth rate of 18 per cent, particularly the emerging multimarker detection market. "Progress in the feasibility of multimarker detection is driving a global trend towards the frequent use of point-of-care technologies in emergency departments. What we are beginning to see is a dynamic co-evolution of biomarkers and point-of-care technologies as the vanguard of in vitro diagnostics," commented Pappas.
The technology developed by Han and Hossein-Zadeh is a novel compact, integrated sensor consisting of several technologies on a single chip to detect ultra-low concentrations of biomarkers with high sensitivity. Specifically, the lab-on-a-chip sensor platform was developed to detect multiple cardiac biomarkers from microliter blood samples, but it can also be used to detect other trace biomarkers for cancer and infectious diseases, determining concentrations of different biomarkers in parallel on a single chip.
Quantifying more than one biomarker in a single blood test not only saves money, but allows doctors to gain a better understanding of patients' overall health status. Current protein separation and quantification technologies are not sensitive enough and require large amounts of blood to be drawn. This sensor can rapidly detect (in less than 60 seconds) extremely low concentrations of biomarkers at a sensitivity of 1 nanogram/microliter (20 times lower than the leading biomarker device on the market today). It is also compact (suitable for a handheld device), fully automated, requires minimal training to use, is inexpensive and versatile, and operates with low-power consumption.
The start-up will focus on developing Diagnose.IT (the detection and quantification device) for the professional point-of-care segment of the medical diagnostic device market: hospital emergency departments, physician office labs and clinics, which consist of nearly 1 million physicians and 200,000 potential testing locations in the U.S. alone and a global market size of over $2 billion.
As part of its comprehensive market research, the company has interviewed industry professionals and potential customers to gain an understanding of what users of point-of-care devices want. A customer survey conducted by the company among UNM Hospital emergency medicine faculty and staff revealed that 89% use point-of-care devices to detect biomarkers in blood. Those surveyed also indicated that the most important improvements to current devices are accuracy and time-till-result (speed). The company will also focus on developing its separation technology (the biomarker purification and concentration device) for a second tier of markets: biopharma, biomedical research and clinical trials.
Product development plans include completion of a prototype of the biomarker separation device in one year and a prototype of the biomarker detection/quantification device (Diagnose.IT) within two years of the first prototype. Regulatory approval for the two devices through the Centers for Medicare and Medicaid Services' (CMS) Clinical Laboratory Improvements Amendments Program (CLIA) will allow P.D. Laboratories to sell to the biopharma, biomedical research and clinical trials market while the company seeks FDA approval for Diagnose.IT. The company plans to seek first round funding of $600,000 for development of the separation device prototype. A second round funding of $3 million will be sought for development of the Diagnose.IT prototype.
"The rapid growth of the biomarker diagnostics and point-of-care device markets has created an ideal environment for bringing together this innovative technology and new company," stated STC President & CEO Lisa Kuuttila. "We look forward to working with such a dynamic management team and topnotch inventors."
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