Mission

The mission of Lenima Field Diagnostics LLC is to improve healthcare by bringing revolutionary, groundbreaking molecular diagnostic tests to the forefront of medical care for infectious disease and cancer applications.

The revolutionary piezoelectric plate sensor (PEPS) technology that Lenima is based on is a result of more than ten years of collaborative effort between the founder, Dr. Wan Y. Shih, a biomedical engineer and the co-founder, Dr. Wei-Heng Shih, a materials engineer. This close collaborative effort allows them to create groundbreaking biomedical devices with unmatched performance by unleashing unique materials properties.

Lenima Field Diagnostics (LFD), LLC, was formed by Drs. Wan Shih and Wei-Heng Shih in 2013 to develop molecular diagnostic tests for a wide range of applications in acute as well as chronic infectious disease and circulating cancer marker detection. It has an option agreement to license the piezoelectric plate sensor (PEPS) technology invented by the Shihs at Drexel University. The PEPS technology is capable of self-amplification of its detection signal, affording unprecedented sensitivity, greatly simplifying its genetic testing process, permitting low-cost, rapid, and simultaneous testing of multiple nucleic acids including both DNAs and RNAs in a single step, label-free, and in less than 30 minutes without the need of DNA/RNA isolation, RNA reverse transcription, nucleic acid amplification (NAAT), or expensive fluorescent labels used in current genetic testing.

LFD’s first application is a rapid, low-cost, accurate and point-of-care Clostridium difficile infection (CDI) test. CDI is a leading healthcare associated infection (HAI), causing 14,000 deaths and costing $3B each year in the US. What makes CDI hard to combat is that 75% of CDI first occur outside of hospitals, mainly in nursing homes where there is no CDI genetic testing capability. Even small and medium-size hospitals (80% of the hospital market) also lack rapid CDI genetic testing capability due to cost. The inexpensive and yet accurate PEPS CDI test will allow multiplex, point-of-care CDI genetic testing with PCR-like sensitivity and specificity for small, medium hospitals and nursing homes, which with $20/kit, represents a $124 MM/year market in the US alone.

Lenima aims to raise $2MM in two years for the development of the first clinical prototype. So far, Lenima has successfully obtained $300K through an NIH phase-I STTR grant. Application for a phase-II STTR grant (success rate >48%) is planned for early 2015.

Wan Y. Shih, PhD, Founder

Dr. Wan Y. Shih is presently an Associate Professor of School of Biomedical Engineering, Science, and Health System at Drexel University. She received her BS in physics from Tsing-Hua University in Taiwan in 1976 and her PhD in Physics from Ohio State University in 1984. She was a Research Scientist in the Materials Institute at Princeton University and a Research Associate Professor in the Department of Materials Science and Engineering at Drexel University prior to joining School of Biomedical Engineering at Drexel University in 2006. She is a recipient of the American Ceramic Society 1999 Edward C. Henry Electronics Division Best Paper Award. She became interested in translational biomedical research in ca 2000. Her goal in translational biomedical research has been to combine her physical science and engineering background with medicine to create revolutionary biomedical devices to fulfill unmet needs in medicine. Since 2000, she has amply demonstrated her ability to create original, groundbreaking biomedical technologies such as the groundbreaking piezoelectric finger (PEF) breast cancer detector that detects breast cancers undetectable by Mammography, an intraoperative breast cancer margin assessment tool, and the revolutionary PEPS molecular tests. She has had 100 scientific publications, 21 issued patents and 18 patent applications--including 10 PhD theses, 10 patents/patent applications and more than 40 scientific publications in PEPS and its predecessor, piezoelectric microcantilever sensor (PEMS) alone. In addition to the PEPS technology that Lenima has signed an option agreement with Drexel University, three of her other technologies have also been licensed.

Wei-Heng Shih, PhD, Co-Founder

Dr. Wei-Heng Shih is a professor of the Department of Materials and Science at Drexel University. He received a B.Sc. in physics in 1976 from Tsing-Hua University in Taiwan and completed his Ph.D. degree in Physics in 1984 from Ohio State University. His expertise rests in surface modification of powders by colloidal coating, sol-gel processing of nanoparticles, low-temperature processing of perovskite piezoelectric ceramics, and fabrication of piezoelectric sensors. He has received the American Ceramic Society 1999 Edward C. Henry Electronics Division Best Paper Award and Drexel’s Research Achievement Award. Currently he focuses on the development of aqueous synthesis of nanocrystalline quantum dots for biomedical imaging, environmental and energy applications, as well as highly piezoelectric freestanding films for biosensor, energy harvesting, and optoelectronic applications. He has published 119 journal papers and 21 patents and his inventions have been licensed by 4 companies.

Joseph Zack, MBA, Business Advisor

Mr. Zack has been a C-level Life Sciences Executive for 20 years, spanning Biopharma to Diagnostics, from start-up to blue chip global companies. He has a strong track record of success in transforming/growing early stage and mid cap companies profitably through visionary/incisive leadership, innovation, and a broad operational skill set. He has built commercial organizations from “scratch”, took from inception to launch over a dozen products in his career (some of them blockbusters in their time, and most game changing/disruptive technologies), added to top and bottom line results with successful business development spanning Europe, Asia, Africa, and South America, and has played a significant role in capital formation. Mr. Zack’s particular domain expertise includes infectious disease, oncology, and endocrine diagnostics, regenerative medicine, wound healing, cardiovascular, neurology, and periodontal medicine. Mr. Zack’s most recent corporate role was as Senior Vice President Diagnostics at Metabolon. Other companies where he had senior leadership roles included OraSure Technologies, OraPharma, Advanced Tissue Sciences, and Ciba-Geigy (now Novartis). Currently Mr. Zack is the Principal of Zack Consulting Services, which advises early and midcap domestic and international companies, at the C-level, with business strategy, opportunity assessments, commercialization plans, product development, business development, and capital formation. Mr. Zack has a BA in Biology from Colgate University, and an MBA from St. John’s University.

Kathleen Czupich, MBA, Financial Manager

Ms. Czupich has over 20 years’ experience in business development with companies ranging from early startups to multinational corporations. She is the founder and principal of Artemis Solutions, a life science service firm providing administrative, strategic and operational support to life science companies. She is co-founder and Chief Financial Officer of the Pennsylvania Drug Discovery Institute. Previously, she was the founding administrator for the Institute for Hepatitis and Virus Research and the PA Biotech Center where she managed the financial and administrative aspects of the $7.9 million grant to purchase the PA Biotech Center (PBC) and the resulting building project totaling more than $14 million. She was also instrumental in the negotiation, financing and purchase of the adjacent building, expanding the PBC to 115,000 square feet. She served as chief financial officer for multiple privately held life science companies. In these roles, she held management responsibility for finance, accounting, human resources, development and legal functions. Ms. Czupich’s particular expertise is in the application and administration of federal grants and has raised more than $20 million in non-dilutive grant funding for early stage life science companies.

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