Asuragen is a molecular biology service provider and fully integrated diagnostic
company with its emphasis in mRNA and microRNA. Asuragen is comprised of Pharmaceutical
Services and Molecular Diagnostic business units.
Asuragen’s Pharmaceutical Services Division provides comprehensive outsourcing solutions
to aid in drug development, molecular biology research, and companion diagnostic
test development. Our cGLP laboratory services include project management expertise,
sample preparation know-how, genomic profiling applications, biomarker discovery
capabilities, assay design and validation, CLIA-based clinical testing, bioinformatic
analysis, and a high level of regulatory proficiency. The division has a proven
track record in providing these services to major pharmaceutical and biotechnology
companies as well as academic institutions worldwide.
Asuragen’s Diagnostic Division is dedicated to developing novel molecular diagnostic
products, manufacturing through its cGMP facility, and commercializing worldwide.
Asuragen’s current diagnostic portfolio consists of Signature® Genetic
Testing and Oncology testing products as well as industry leading controls and standards
engineered using its patented Armored RNA® technology.
Complimenting these capabilities is a team of experts that include PhD scientists,
medical doctors, lawyers, and laboratory technicians. Everyone at Asuragen is familiar
with the quality required by pharmaceutical companies, for diagnostic products and
by regulatory agencies. Together with our financial officers, human resource managers,
quality managers, and our commercial business development team, Asuragen provides
you with the expertise and assurance of quality you require.
Matt Winkler, Ph.D. - Chairman of the Board and CSO, Dr. Winkler founded Ambion in 1988,
grew it to $58M in revenue and sold the research products division in 2005 to Applied
Biosystems. He is the founder of Asuragen. Prior to founding Ambion he was an Associate
Professor of Zoology at the University of Texas at Austin. He has a B.S. degree
in Genetics and a Ph.D. in Zoology from the University of California at Berkeley.
Rollie Carlson, Ph.D. - President and CEO, Dr. Carlson joined Asuragen
in April 2006 and has over 20 years of Commercial, Business Development, & New Product
Development experience in Biotechnology. Dr. Carlson held several senior positions
at Abbott Laboratories most recently as Vice President and General Manager of the
Vysis molecular diagnostic business following its acquisition by Abbott where he
drove significant increased sales and profit growth through pharmacogenomic oncology
initiatives (i.e. PathVysion® HER-2 diagnostic for Herceptin®
therapy), new diagnostic PMAs, 510Ks and CE-Mark IVDs, automated instrument introductions,
increased CMS reimbursement, and international expansion. He was also responsible
for business development, licensing and strategic planning to establish new pharmaceutical
and diagnostic platforms and, ran Abbott’s custom biopharmaceutical development,
specialty generics and global bulk pharmaceutical business. Dr. Carlson has a Ph.D.
in Plant Physiology from Southern Illinois University.
Carol E. Berry, MBA - is currently serving as the Senior Vice President and
General Manager of Asuragen Inc’s Pharmcogenomic Services Division and CLIA Laboratory.
Ms. Berry has over 20 years of executive management experience in the diagnostic and
biotechnology industry. Prior to Asuragen, Ms. Berry was Vice President of Sales and
Marketing at AviaraDx, a start-up molecular oncology company focused on commercializing
novel tests in breast cancer and metastatic cancer. In 2002, Ms. Berry joined the senior
management team at Ciphergen Biosystems, Inc. a proteomic equipment and pharmacoproteomic
research company. She held a variety of positions ranging from business development to
head of worldwide sales and marketing. Ms. Berry started her diagnostic career at
Roche Biomedical Laboratories where she enjoyed expanding her knowledge and responsibilities
for ten years from a sales territory manager to one of the top fifty General Managers in
the company. Carol received her Bachelor of Science degree from Texas A&M University and a
Masters in Business administration/Information Technology from University of Dallas.
Lynne Hohlfeld joined Asuragen as Chief Financial Officer and Secretary
in March 2009. Ms. Hohlfeld has extensive experience in financial management of
life science companies. From April 2006 to March 2009, Ms. Hohlfeld served as Chief
Financial Officer of Opexa Therapeutics (Nasdaq: OPXA), a company developing novel
cell therapies for autoimmune diseases. From September 2004 until April 2006, she
was vice president and chief financial officer of Denota Ventures. From August 2000
until March 2004 she was senior vice president, chief operating and financial officer
of Bacterial Barcodes, Inc., a Houston-based molecular diagnostics company spun
out of the Baylor College of Medicine. She was also senior vice president and chief
financial officer of Spectral Genomics of Houston upon its merger with Bacterial
Barcodes in March 2004. Ms. Hohlfeld was also employed by LifeCell Corporation from
1997 to 1999, serving as controller. Ms. Hohlfeld’s career includes positions at
Dixie Chemical Company, Price WaterhouseCoopers, McKenna & Company, and Arthur Andersen.
Ms. Hohlfeld received a B.B.A. in accounting from the University of Wisconsin—Madison
and is a certified public accountant.
Luc Van Hove, M.D., Ph.D., CSSBB - Senior Director Clinical Affairs,
Regulatory and Quality, Dr. Luc Van Hove was trained as a clinical pathologist at
the University Hospital of Leuven in Belgium. He earned his medical degree, a PhD
in immunology and his board certification in clinical pathology at the KULeuven.
His work focused on the introduction of new diagnostic tests in the clinical laboratory
for leukemia identification and drug resistance using flow cytometry.
Dr. Van Hove recently joined Asuragen in Austin, Texas, where his current responsibilities
include clinical affairs, regulatory affairs and quality assurance. He is responsible
for coordination, review and submissions to the US Food and Drug Administration
(FDA) and European Regulatory Authorities. Dr. Van Hove holds a Six Sigma Black
Belt credential to develop and implement business/process excellence and continuing
Prior to Asuragen, Dr. Van Hove held management responsibilities at Exagen Diagnostics,
as vice president quality, regulatory and medical affairs. He implemented the company’s
quality system and directed clinical trials and FDA applications. Prior to Exagen,
Dr. Van Hove was with Abbott Diagnostics for 14 years, where he developed and led
medical affairs departments and held worldwide responsibility for hematology, oncology,
viral markers and systems development. He directed numerous clinical studies and
was involved in regulatory submissions as Medical Director.
Ana C. Ward, Esq., M.S., M.B.A. - Ms. Ward is currently Senior
Vice President, General Counsel for Asuragen, Inc. Prior to Asuragen, she was General
Counsel for Ambion and was responsible for a wide variety of legal issues including
licensing, corporate transactions, patents, and trademarks. Prior to joining Ambion,
Ms. Ward served as Senior Intellectual Property Counsel for Tricon Global Restaurants,
Inc., and as an associate at the law firm Sidley & Austin. She has a BA in French/Zoology,
a Masters in Molecular Biology, a Doctor of Jurisprudence, and a Masters of Business
Administration, all from the University of Texas at Austin. Ms. Ward is also a registered
patent attorney, and served as an adjunct professor at the UT School of Law.