IRINA NAZARENKO, PHD
3 Rudis Way, Gaithersburg, MD 20878
Irina.nazarenko18@gmail.com
301.926.7069
US-citizen
Cell: 301.525.8256
SUMMARY
Specialist in the field of nucleic acids biochemistry, molecular biology and diagnostics with more than
20 years of academic and industrial experience with proven leadership roles. Proficient in EnglishRussian and Russian-English Translator certified for “simultaneous translation”. Have experience in
translating scientific papers, patens and marketing materials.
Key strengths are: broad scientific background in fields of nucleic acids enzymology and interactions
with proteins, cancer diagnostics and biomarkers; ability to create and lead productive and motivated
research teams; good understanding of commercial applications of basic research and regulatory
requirements. Bilingual.
EDUCATION
Post-doctorate, UNIVERSITY OF COLORADO IN BOULDER, Boulder, CO
PhD, Biochemistry and Molecular Biology, Institute of Molecular Biology and Genetics of the Academy
of Sciences, USSR
MS, Biochemistry, Novosibirsk University, Russia, USSR
BS, Biology, of Novosibirsk University, Russia, USSR
PROFESSIONAL DEVELOPMENT
Certificate, Simultaneous interpreter, Novosibirsk State University, Russia
Certificate, Fluorescent Spectroscopy, University of MD, College Park, MD
Courses on Statistical Analysis, Quality Control, GLP, Clinical Regulatory, Management at Qiagen
SELECTED ACCOMPLISHMENTS
During academic career, mentored graduate students and post-docs; collaborated with other
academic labs, discovered important mechanisms of nucleic acid-protein interactions, published
multiple papers, had patents issued. In Russia also worked as an interpreter.
As an R&D leader in number of US biotechnology and diagnostic companies developed junior
scientists that resulted in the professional and career growth for more than 50% of the staff; was a PI
on several grants from government and private institutions; developed new assays for in vitro
diagnostics; organized clinical studies; invented several technologies and led the development of
corresponding products; collaborated with clinical and academic institutions in technology evaluation.
PROFESSIONAL EXPERIENCE
QIAGEN, Gaithersburg, MD (initially Digene, acquired by Qiagen in 2007)
2002 – 2011
Director of Feasibility Research, R&D
Managed teams of 15-20 scientists with $1.5M / year operating budget towards the development of
new diagnostic assays for pathogens and cancer biomarkers. Reported to Sr. Director and to Sr. VP
of R&D. Responsibilities included: product design, research and initial development; external
collaborations for technology-evaluation and clinical studies; patent applications, publications and
presentations for executive teams and scientific conferences.
IRINA NAZARENKO, PHD
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QIAGEN (Continued)
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Developed diagnostic technologies including sequence-specific sample preparation, isothermal
amplifications and multiplex detection.
Projects resulted in two products transferred to
manufacturing, issued patent, multiple patent applications and publications.
Was a PI on $2.5M grant for the development of diagnostics for low-resource setting.
Organized and managed clinical study that demonstrated a new diagnostic application for hybrid
capture assay-screening for anal cancer.
Performance was most often rated by supervisors as “outstanding”.
LIFE TECHNOLOGIES, Rockville, MD (acquired by Invitrogen in 2001)
1998 – 2001
Senior Scientist, R&D
Led a group of scientists in the development of a new cost-effective method of fluorescent detection of
nucleic acids. Coordinated the efforts of several departments in product development based on this
technology. Additionally, participated in the development of reagents and kits for PCR, SNP detection
and gene expression. Responsibilities also included, IP analysis, technical reports, presentations to
executive teams at scientific conferences.
 Successfully led the team towards cost-effective PCR reagents (LUX primers) which is currently a
commercial product protected by issued patent and described in several publications.
ONCOR INC, Gaithersburg, MD (acquired by Intergen in 1998)
1994 – 1998
Senior Scientist, R&D
Supervised 1-3 junior scientists in project towards new amplification system. Initiated a new project
towards new method of detection of amplification products. Served as Principle investigator of SBIR
grants and as technical liaison during company acquisition by Intergen.
 As an inventor of novel technology for fluorescent detection and a PI on SBIR grants (phase I and
II) led the team towards commercialization of this technology. Results are published and patents
issued. Currently AmplifluorR primers is a commercial product sold by Millipore.
 Co-invented and developed a novel amplification technology. Participated in the development of
number of assays for cancer biomarkers based on methylation-specific PCR.
UNIVERSITY OF COLORADO IN BOULDER, Boulder, CO
1990 – 1994
Visiting Professor / Research Scientist with Prof O. Uhlenbeck
Performed research in the field of RNA-protein interaction, in vitro transcription. Presented results in
multiple publications and conferences. Supervised graduate students and post-docs.
 Discovered and published some important features of the interaction between tRNA, elongation
factors and ribosomes.
RESEARCH INTERESTS
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Nucleic acids enzymology; nucleic acid-protein and protein-protein interactions
Cancer biomarkers
Human papillomavirus – association with cancer
Nucleic acids amplification / detection methods and their applications (gene expression, SNPs)
Development of clinical molecular tests for infectious diseases and cancer biomarkers
Nucleic acid structure, creation of new bio-molecules via SELEX and in vitro transcription.
IRINA NAZARENKO, PHD
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TECHNICAL EXPERTISE
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Russian- English and English-Russian translation of scientific, legal and marketing publications.
Certified simultaneous interpreter
Amplification technologies (PCR, real-time PCR, RT PCR, methylation-specific PCR, SNPs)
Bead-array (Luminex) and micro-chip technologies for detection in multiplex
In vitro transcription and selection (SELEX)
Cloning and Expression
Nucleic Acids Purification, Sequencing, Modification, Labeling and Immobilization
Protein Small and Large Scale Purification
PUBLICATIONS
1. Brian Lowe, Anna Fulbright and Irina Nazarenko (2012). A Hybrid Capture Assay to Detect HPV
mRNA Ratios in Cervical Specimens. J. of Virol. Methods, 2012, 179(1), 142-7.
2. Victoria Doseeva, Thomas Forbes, John Wolff, Dominic O’Neil, Yuri Khripin, Thomas Rothmann
and Irina Nazarenko (2011). Multiplex Isothermal Helicase Dependent Amplification Assay for
Detection of Chlamydia trachomatis and Neisseria gonorrhea. Diagn Microbiol Infect Dis. 2011
Dec; 71(4):354-65.
3. Dominic O’Neil, Victoria Doseeva, John Wolff and Irina Nazarenko (2011). Evaluation of
Chlamydia trachomatis and Neisseria gonorrhea Detection in Urine, Endocervical and Vaginal
Specimens by a Multiplexed Isothermal tHDA Assay. J. Clin. Microbiology 2011, 49(12), 4121-5.
4. Stephen E. Goldstone, Brian Lowe, Thomas Rothmann and Irina Nazarenko (2012). Evaluation of
the Hybrid Capture 2 Assay for Detecting Anal Oncogenic HPV and High-grade Dysplasia. Int J
Cancer. 2012 Jan 10. doi: 10.1002/ijc.27431. [Epub ahead of print]
5. Brian Lowe, Stephen E. Goldstone, Szymon Rus, Hiam Salim, Guorong Chen, Thomas Rothmann
and Irina Nazarenko (2012). Detection of Human Papillomavirus in Anal Specimens Using Hybrid
Capture 2 Assay. Cancer Cytopathology (in press).
6. Anna Fulbright, Brian Lowe and Irina Nazarenko (2011). HPV E2 mRNA Disruption Detected by
Reverse Hybrid Capture. (Submitted).
7. Brian Lowe, Dominic O’Neil, Dirk Loeffert and Irina Nazarenko (2011). Distribution of Human
Papillomavirus Load in Clinical Specimens. J Virol Methods. 2011 Apr; 173(1):150-2.
8. Lowe, B., Kobayashi, L., Lorincz, A., Mallonee, R., O'Neil, D., Thai, H., and Nazarenko, I. (2010).
HPV Genotype Detection Using Hybrid Capture Sample Preparation Combined with Whole
Genome Amplification and Multiplex Detection with Luminex XMAP. J Mol Diagn. 12(6):847-53.
9. I. Nazarenko, L. Kobayashi, J. Giles, C. Fishman, G. Chen and A. Lorincz (2008). A novel Method
of HPV Genotyping Using Hybrid Capture® Sample Preparation Method Combined with GP5+/6+
PCR and Multiplex Detection on Luminex® XMAP®. Journal of Virological Methods 154, 76–81.
10. I. Nazarenko, L. Kobayashi, J. Giles, C. Fishman, G. Chen and A. Lorincz (2008). A novel Method
of HPV Genotyping Using Hybrid Capture® Sample Preparation Method Combined with GP5+/6+
PCR and Multiplex Detection on Luminex® XMAP®. Journal of Virological Methods 154, 76–81.
11. H. Thai, S. Rangwala, T. Gay, K. Keeting, S. McLead, I. Nazarenko, D. O’Neil, D. Pfeister and D.
Loeffert ( 2009). An HPV16 18 and 45 Genotyping Based on Hybrid Capture Technology. J. of
Clinical Virology 45, S93-S97.
IRINA NAZARENKO, PHD
PAGE FOUR
12. G. Chen, L. Kobayashi and I. Nazarenko (2007). Effect of Sample Aliquot Size on the Sensitivity
and Reproducibility of Clinical Assays. Clinical Chemistry, 53, 1962-1965.
13. Irina Nazarenko (2006). Oligonucleotides Labeled with a Single Fluorophore as Fluorogenic
Reagents for Nucleic Acids Detection. Humana Press (Methods in Molecular Biology) v 335, p 95115.
14. Irina Nazarenko, Rick Pires, Brian Lowe, Mohamad Obaidy and Ayoub Rashtchian (2002). Effect
of Primary and Secondary Structure of Oligodeoxynucleotides on the Fluorescent Properties of
Conjugated Dyes. Nucleic Acids Res., 30, 2089-2095.
15. Irina Nazarenko, Brian Lowe, Marlene Darfler, Pranvera Ikonomi, David Schuster and Ayoub
Rashtchian (2002). Multiplex Fluorogenic PCR Using Self-quenched Primers Labeled with a Single
Fluorophore. Nucleic Acids Res.30, e37.
16. H. Uehara, G. Nardone, I. A. Nazarenko and R. Hohman (1999). Detection of Telomerase Activity
Utilizing Fluorescence Energy Transfer Primers. Biotechniques, 26, 552-558.
17. G. J. Nuovo, R. Hohman, G. Nardone and I. A. Nazarenko (1998). In situ Amplification Using
Universal Energy Transfer-labeled Primers. J. Histochemistry and Cytochemistry, 47, 273-279.
18. I. A. Nazarenko, S. Bhatnagar and R. Hohman (1997). A Closed-tube Format for Amplification
and Detection of DNA Based on Energy Transfer. Nucleic Acids Res., 25, 2516-2521.
19. I. A. Nazarenko and O. C. Uhlenbeck (1995).
Biochemistry, 34, 2545-2552.
Defining a Smaller RNA sSbstrate for EF-Tu.
20. I. A. Nazarenko, K. H. Harrington and O. C. Uhlenbeck (1994). Many of the Conserved
Nucleotides of tRNAPhe Are Not Essential for Ternary Complex Formation and Peptide Elongation.
EMBO J., 13, 2464-2471.
21. K. H. Harrington, I. A. Nazarenko, D. B. Dix, R. C. Thompson and O. C. Uhlenbeck (1993). In vitro
Analysis of Translational Rate and Accuracy with an Unmodified tRNA. Biochemistry, 32, 76177622.
22. I. A. Nazarenko, E. Tinkle Peterson, O. D. Zakharova, O. I. Lavrik and O. C. Uhlenbeck (1992).
Recognition Nucleotides for Human phenylalanyl-tRNA synthetase. Nucl.Acids Res., 20, 475-478.
23. N. Moor, I. Nazarenko, V. Ankilova and O. Lavrik (1992). Determination of tRNAPhe Recognition
Nucleotides for phenylalanyl-tRNA synthetase from Thermus thermophilus. Biochimie, 74, 353356.
24. I. A. Nazarenko and V. V. Gorn (1991). Effect of Nucleotide Replacement on the Effectiveness
and Specificity of the SP6 Promotor. Mol. Biol. (Mos) 25, 1661-1666.
25. I. A. Nazarenko and L. V. Matskova (1990). The Dependence of the Silver-staining of
Polyribonucleotides on PAAG on Nucleotide Sequence. Biopolymeri i kletka, 6, 75-79.
26. N. A. Chikaev, I. A. Nazarenko, E. G. Malygin and V. E. Repin (1987). Exonuclease III from
Bacillus amyloliquefaciens. Biokhimia, 52, 1397-1404.
27. N. A. Chikaev, I. A. Nazarenko, S. S. Bogachev and E. G. Malygin (1987). Determination of
Inhibition Sites during Hydrolysis of Polydeoxyribonucleotides by Exonucleases III from B. subtilis
and E. coli. Biokhimia, 52, 1454-1460.
28. I. A. Nazarenko, I.A. Gorbunov and E. G. Malygin (1987). Cleavage of Synthetic RNA-DNA
Hybrids with Restriction endonucleases Bam HI and Sau 3A. Bioorg. Khim, 13, 928-933
IRINA NAZARENKO, PHD
PAGE FIVE
29. N. Kolesnicov, I. Kiknadze, N. Chikaev and I. A. Nazarenko (1986). “Molecular Approaches to the
Investigation of Polytene Chromosomes Locuses" book chapter in: "The Evolution and Systematic
of Chironomids." Novosibirsk, Russia, p.143-156.
30. I. A. Nazarenko, L. E. Bobko , A. G. Romaschenko, Y. L. Khripine and R. I. Salganik (1979).
Unprimed Poly (dA-dT) Synthesis Catalyzed by Preparations of E.coli DNA Polymerase. Mol. Biol.
(Mosk), 13, 216-227.
31. I. A. Nazarenko, L. E. Bobko , A. G. Romaschenko, Y. L. Khripine and R. I. Salganik (1979). A
Study on the Unprimed Poly (dA-dT) Synthesis Catalyzed by Preparations of E.coli DNA
Polymerase. Nucleic Acids Res., 6, 2545-2560.
32. I. A. Nazarenko, V. A. Potapov, A. G. Romaschenko and R. I. Salganik (1978). Separation of the
Enzyme Catalyzing Polymerization of dNDP from the Preparations of E.coli DNA Polymerase.
FEBS Lett., 86, 201-204.
33. I. A. Nazarenko, T. A. Belyaeva, V. A. Potapov and R. I. Salganik (1976). Separation of the
Enzyme Catalyzing Polymerization of dNDP from the Preparations of E.coli DNA Polymerase. Mol.
Biol. (Mosk), 10, 1231-1237.
ISSUED PATENTS
1. Irina Nazarenko, Attila Lorincz, Paul Eder, Brian Lowe, Richard Mallonee, Ha Thai “Detection
of nucleic acids by target-specific hybrid capture method” US 7,601,497, October 13, 2009.
2. I. Nazarenko and Ayoub Rashtchian “Primers and Methods for the detection and
discrimination of nucleic acids”, US 7,537,886, May 26, 2009.
3. I. Nazarenko S. Bhatnagar, E. Winn-Dinn, R. Hohman ”Nucleic acids amplification
oligonucleotides with molecular energy transfer labeles and methods based thereon”US
6,090,552. July 18, 2000.
4. I. Nazarenko, S. Bhatnagar, E. Winn-Dinn, R. Hohman ”Nucleic acids amplification
oligonucleotides with molecular energy transfer labeles and methods based thereon”US
6,117,635. September 12, 2000.
5. I. Nazarenko, S. Bhatnagar, E. Winn-Dinn, R. Hohman “Nucleic acid amplification
oligonucleotides with molecular energy transfer labels 6,090,552, July 18, 2000.
6. G. Nardone, I. Nazarenko, J. Boal “Pyrimidines linked to a quencher”6,117,986. September
12, 2000.
7. I. Nazarenko, S. Bhatnagar, E. Winn-Dinn, R. Hohman “Nucleic acid amplification
oligonucleotides with molecular energy transfer labels and methods based thereon” US
5,866,336. February 2, 1999.
8. A. George, S. Bhatnagar, I. Nazarenko “Method for analyzing a nucleotide sequence” US
5,728,526. March 17, 1998.
9. S. Bhatnagar, J. George, I. Nazarenko “Amplification of nucleic acids sequences.”
5,593.840, January 14, 1997.
US
IRINA NAZARENKO, PHD
PAGE SIX
10. I.A. Nazarenko, V.V. Gorn, T.P. Artamonova "A synthetic promoter for bacteriophage SP6
RNA-polymerase" USSR SU-1,759,873 (Cl.C 12 N15/11), Appl. 4,859,449, 14 Aug.
1990.Otkrytiya, Izobreteniya 1992 (33), 89. September 7, 1992.
11. N. A. Chikaev , I.A. Nazarenko, L.V. Matskova "Purification of restriction enzyme Bam H1 and
exonuclease III from Bacillus amyloliquifaciens" USSR SU 1,661,211 (CL, C 12 N9/14), 07 Jul
1991, Appl. 4,718,569, 11 Jul 89. Otkrytiya, Izobreteniya 1991 (25), 95. July 7, 1991.
12. I.A. Nazarenko, L.V. Matskova "Method of staining of polynucleotides and proteins in PAAG",
SU-1401381. Int.Cl.G 01 N 33/483. publ.1988.
13. I.A. Nazarenko, Yu.S. Nechaev, A. Ya. Stepka, B. O. Valtere "Refining preparation of ox
serum albumine", USSR SU-1,183,504 (Int. Cl. C 07 G7/00) 07 Oct. 1985. Appl. 3,496,970, 04
Oct. 1982. Otkrytiya, Izobreteniya 1985 (37),105.
14. T.A. Belyaeva, I.A. Nazarenko, V.A. Potapov, , R.I. Salganik "Method of purification of
enzymes from E.coli" SU-961378, 21.02.82.