V. Shyamala 1 7/26/2012

Venkatakrishna Shyamala, Ph. D.

Molecular Diagnostics and Blood Testing (>25 years Biotech experience) E-mail: vshyamala@netscape.net ; Web Contact: http://www.linkedin.com/in/vshyamala

Country of Citizenship: United States of America

RESEARCH AND WORK EXPERIENCE

Independent Consultant

10/2008

To Present

Consultant, Molecular in vitro Diagnostics, Blood Screening and Molecular Biology

Consultant – Novartis Vaccines and Diagnostics, Scientific Affairs; Achira Labs Inc., India;

Reuters Insight Expert, Zintro Expert

CLSI Area committee for Molecular Methods-Observer; subcommittee participant for “Point-of-

Care Testing for Infectious Diseases”, “Nucleic Acid Sequencing Methods in Diagnostic

Laboratory Medicine” and “Microarrays for diagnosis and Monitoring of Infectious Diseases”.

CLSI publications: MM01 (2012)- Molecular Methods for Clinical Genetics and Oncology

testing 3rd

Ed.; MM19 (2011) Establishing Molecular Testing in Clinical Laboratory

Environments; MM09 (2010) Quantitative Molecular Methods for Infectious Diseases 2nd

Ed.

At Innovative Biosensors, Inc., Rockville, Maryland

7/2007 To

10/2008

Senior Vice President, Research and Development; Clinical Diagnostics on CANARYTM

platform,

Next generation technologies

2 provisional patent applications

Leading a team of 10 scientists tasked to facilitate developing and launching Diagnostics assays

for MRSA, Chlamydia trachomatis and Group B Streptococcus; Feasibility evaluation of Next

Generation technologies.

Initiated Pilot Clinical trial studies at Indiana University and UM Shock Trauma Center for the

CANARYTM

-MRSA assay and CANARYTM

-Chlamydia assays.

3 year NSF-MASINT grant to develop Hand-held Biosensors in collaboration with the

Engineering department at Univ of Maryland at College Park.

At Digene Corporation, Gaithersburg, Maryland

3/2006 To

7/2007

Director; Assay Development, Next Generation Platform Technologies for Nucleic Acid Detections

of HPV, CT and NG

5 Invention Disclosures

Leading a team of 14 scientists tasked to facilitate development of Next Generation assay for

Chlamydia trachomatis and Neisseria gonorrhoea.

Completed Analytical Sensitivity comparison of commercially available nucleic acid detection

assays including Roche, GenProbe, and Abbott for 16 serovars of CT with Digene Hybrid

CaptureR, Digene Isothermal and Digene Helicase Dependent Amplification assays.

Chiron Corporation 1990-2006

At Chiron Corporation-Blood Testing Division, Emeryville, California

6/2004 To

3/2006

Associate Director; Research Leader of the Next Generation Platform Technologies for Nucleic Acid

Detections of HBV, HCV, WNV, Parvo B19 and HAV for Blood Screening.

5 publications, 9 presentations at Scientific conferences.

Leading a team of 3 scientists and several research associates to quickly evaluate and identify the

best amongst 10 Nucleic acid isolation technologies in the newly assigned project.

Established collaborations with 8 companies and tested in-house, novel amplification-detection

technologies.

Have been a liaison as assay development expert to other departments, affiliates and customers in

the existing and new product related questions.

year NSF grant to develop a diagnostic assay for the detection of Hanta Virus in collaboration

with Univ of Arizona.

4/2000 To

6/2004

Senior Scientist-Associate Director; Research Leader and Project Team Leader of the PCR based

Alternative NAT assays for HBV, HCV and WNV for Blood Screening.

5 publications, 4 patents, 27 presentations at Scientific conferences.

Led and managed assay development teams for HBV, HCV and WNV Tests; research and

development activities, including optimizations of assay reagents and test system, and transfer of

product to Reference Testing Laboratories.

V. Shyamala 2 7/26/2012

Worked in liaison with Validation, Statistics, Marketing/Business Development, Regulatory-

Clinical affairs & Scientific affairs to design and execute Market evaluations, Registration studies.

Identified, negotiated and placed the Confirmatory Alternative assays for HBV and WNV in the

GMP qualified Bayer Reference and Testing Laboratories (BRTL), and the HCV assay at Blood

Systems Research Institute (BSRI).

Played a key role in IND and BLA submissions of Procleix-Duplex (HCV) and Procleix-Ultrio

(HBV) in confirming the Clinical trial positives. Key role in IND submission of Procleix-WNV

assay. Helped the Regulatory Affairs to review the Clinical report for Procleix-Ultrio for CE Mark

and FDA submission and approval.

Participated in several Coded studies offered by US and Canadian Blood banks, CBER (USA),

QCMD (UK), ISS & EQA (Italy) and VQC (Netherlands) for HCV, HBV and WNV Qualitative

and Quantitative assays. Publication and presentation of these data, resulting in numerous

collaborations.

Interfaced with Chiron Legal department to research on competitor marketed HIV and HCV assay

reagents.

At Chiron Corporation -Technologies Division, Emeryville, CA

1/1996 To

10/2000

Principal Scientist, Coordinated the efforts of scientists from various disciplines including

chemistry, high-through put screening and phage display to examine the effect of ligand

dimerization on receptor activation. Generated cell lines overexpressing recombinant and chimeric

receptor. Set up ligand binding and signaling assays for high through-put screening. Identified

novel orphan receptors, and determined their expression profile.

6/1994 To

1/1996

Research Scientist. Analyzed signaling by tumor necrosis factor receptors I and II. Identified

kinase interacting proteins by the yeast two hybrid system.

Identified novel, alternatively spliced endothelin B receptor. Defined features of IL-8 to interact and

signal with IL-8 receptors 1 and 2. Defined signaling molecules for IL-8 receptors.

Identified and isolated several novel orphan seven transmembrane receptors.

6/1990 To

6/1994

Research Biochemist, Identified conserved sequences in the 5’ and 3’ region of Hepatitis C viral

RNA. Developed an internal standard RNA for RT-PCR based quantitation of hepatitis C viral

RNA in tissue samples. Examined the translational control by the untranslated 5’ end of HCV RNA.

Post-Doctoral Experience

1986-1990 Visiting Scientist Department of Biochemistry, University of California at Berkeley, CA.

Developed PCR based methods for gene analysis. Studied structure-function relationship of the

bacterial histidine permease and recombination events.

1984-1986

1983-1984

1979-1983

Scientist. Pacific Presbyterian Hospital, San Francisco, CA.

Post Doctoral Fellow (with Dr. J. Inselburg). Dartmouth College, Hanover, NH.

Post Doctoral Fellow (with Dr. H. W. Dickerman) NY State Department of Health Albany, NY.

EDUCATION

1973-1979 Ph.D., Department of Biochemistry, Indian Institute of Science, Bangalore, India.

Thesis: Effect of starvation on rat liver organelles.

AREAS OF EXPERTISE

Background Ph.D. in Biochemistry and Molecular Biology

Assay

Development

and Technical

Evaluated Nucleic Acid Testing (NAT) technologies, extensive virology and bacteriology experience,

Primer/probe designs and NAT assay development; Strong troubleshooting skills and innovative

thinking; Novel NAT detection methods, cDNA library screening, molecular cloning, sequencing and

expression.

Scientific

Affairs

Developed and maintained contacts with key external opinion leaders, clinical investigators, and

other key customers in blood screening and diagnostic field; Marketing study designs; Authored

several original publications; Presented scientific data at numerous professional conferences; Solid

V. Shyamala 3 7/26/2012

knowledge and experience on assay development and product improvements; Critical data analysis

and interpretation. Recruited subject experts to IBI Scientific Advisory Board, monthly progress

presentations to Board members, procured NSF-MASINT and NIH grant.

Other Areas Reviewed Clinical trial data for IND and BLA preparation and submission; B round financing of $12

million for IBI; IRB procurement to initiate pilot MRSA clinical studies

EXTRA MURAL FUNDING

2008-2010 3 year NSF-MASINT grant to develop Hand-held Biosensors in collaboration with the Engineering

department at Univ of Maryland at College Park.

2003-2007

2007-2008

year NSF grant to develop a diagnostic assay for the detection of Hanta Virus in collaboration

with Univ of Arizona.

Invited reviewer by NSF for the Ohio State interdisciplinary grant.

SELECTED PUBLICATIONS

Patents

Issued/Filed Patents: 1. C. Cote, Q.-X. Zheng, V. Shyamala, T. Hazel: Methods and Systems for Detecting Methicillin-

Resistant Staphylococcus (2008) PCT/US09/43143

2. V. Shyamala, S. Pichuantes and S. Nguyen: Methods and Reagents for Detecting Hantavirus (2005) WO 2008/008444 A2

3. V. Shyamala: Identification of oligonucleotides for the capture, detection and quantitation of

Hepatitis A viral RNA (2003) WO2003/106641.

4. V. Shyamala: Identification of oligonucleotides for the capture, detection and quantitation of

West Nile viral RNA (2002) WO2004/055159 A2; US 7,132,233 B2.

5. S. Pichuantes, and V. Shyamala: Diagnostic assays for Parvovirus B19 (2002) WO 03/002753

A2; US 6,936,442 (2005).

Original

Papers

Since 1989

1. R. Emmadi, J.B. Boonyaratanakornkit, R. Selvarangan, V. Shyamala, B. L. Zimmer, L.

Williams, B. Bryant, T. Schutzbank, M. M. Schoonmaker, J. A. Amos Wilson, L. Hall, P.

Pancholi and K. Bernard (2011) Molecular methods and platforms for infectious diseases

testing. A review of FDA approved and cleared assays. J. Mol. Diagnostics 13, 583-604.

2. S. Kleinman, S. Glynn, T.-H. Lee, L. Tobler, L. Montalvo, D. Todd, J. Kiss, V. Shyamala, M.

Busch (2007) Prevalence and quantitation of Parvovirus B19 DNA levels in blood donors using

a sensitive PCR screening assay. Transfusion 47, 1756-1764.

3. M. Busch , S. Caglioti, G. Robertson, J. McAuley, L. Tobler , H. Kamel, J. Linnen, V.

Shyamala, P. Tomasulo, and S. Kleinman (2005) Screening the blood supply for West Nile

Virus RNA by nucleic acid amplification testing. New Engl. J. Med. 353, 460-467.

4. M. P. Busch, L.H. Tobler, J. Saldanha, S. Caglioti, V. Shyamala, J. Linnen,

J. Gallarda, B.

Phelps, R. Smith, and S. H. Kleinman (2005) Analytical and Clinical Sensitivity of First

Generation West Nile Virus RNA Screening and Confirmatory Assays. Transfusion 45, 492-

499.

5. A. Cox, D. M. Netski, T. Mosburger, S.G. Sherman, S. Strathdee, D. Ompad, D. Vlahov, V.

Shyamala, D. Chien, S. C. Ray and D. Thomas (2005) Prospective evaluation of community-

acquired acute hepatitis C. Clin. Infect. Dis. 40, 951-958.

6. L. H. Tobler, C. Bianco, S. A. Glynn, G. B. Schreiber, B. J. Dille, H. E. Prince, R. S. Lanciotti,

J. M. Linnen, J. Galarda, V. Shyamala, D. Smith, S. H. Kleinman and M. P. Busch (2005)

Detection of West Nile Virus (WNV) RNA and antibody in frozen plasma components recalled

from the 2002 peak epidemic. Transfusion 45, 480-486.

7. V. Shyamala, P. Arcangel, J. Cottrell, D. Coit, A. Medina-Selby, C. McCoin, D. Madriaga, D.

Chien and B. Phelps (2004) Assessment of the Target-Capture PCR Hepatitis B Virus (HBV)

DNA Quantitative Assay and Comparison with Commercial HBV DNA Quantitative Assays. J.

Clin. Microbiol. 42, 5199-5204.

V. Shyamala 4 7/26/2012

8. G. Pisani, K. Cristiano, J. Saldanha, M. Wirz, G. M. Bisso, C. Mele, G. Gentili and the EQA

Participants. (2004) External quality assessment for the detection of blood-borne viruses in

plasma by nucleic acid amplification technology: the first human immunodeficiency virus and

hepatitis B virus studies (HIV EQA/1 and HBV EQA/1) and the fifth hepatitis C virus study

(HCV EQA/5). Vox Sanguinis 87, 91-95.

9. V. Shyamala, J. Cottrell, P. Arcangel, D. Madriaga, J. Linnen, B. Phelps, and D. Chien (2004)

Detection and quantitation of HBV DNA in the WHO International standard for HIV-1 RNA. J.

Virol. Meth. 118, 69-72.

10. C. Gentili, G. Pisani, J. Saldhana, K. Cristiano, Wirz, G. M. Bisso, C. Mele, and the EQA

participants. (2003) High proficiency in detecting the six major hepatitis C virus genotypes of

laboratories involved in testing plasma by nucleic acid amplification technology. Vox

Sanguinis 85, 114-116.

11. J.-P. Allain, D. Candotti, K. Soldan, F. Sarkodie, B. Phelps, C. Giachetti, V. Shyamala, F.

Yeboah, M. Anokwa, S. Owusu-Ofori, and O. Opare-Sem (2003) The risk of hepatitis B virus

infection by transfusion in Kumasi, Ghana. Blood 101, 2419-2425.

12. H. Khoja, G. Wang, C.-T. Lee Ng, J. Tucker, T. Brown, and V. Shyamala (2000) Cloning of

CCRL1, an orphan seven transmembrane receptor related to chemokine receptors, expressed

abundantly in the heart. Gene 246, 229-238.

13. M.D. Ballinger, V. Shyamala, L. D. Forrest, M. Deuter-Reinhard, L.V. Doyle, J. X. Wang, L.

Panganiban-Lustan, J. R. Stratton JR, G. Apell, J. A. Winter, M. V. Doyle, S. Rosenberg, W.M.

Kavanaugh (1999). Semirational design of a potent, artificial agonist of fibroblast growth factor

receptors. Nat. Biotechnol. 17, 1199-1204.

14. V. Shyamala, H. Khoja, M. L. Anderson, J.-X. Wang, H. Cen, and W. M. Kavanaugh (1999)

High-throughput screening for ligand-induced c-fos mRNA expression by branched DNA assay

in chinese hamster ovary cells. Anal. Biochem. 266, 140-147.

15. V. Shyamala, and H. Khoja (1998) Interleukin-8 receptors R1 and R2 activate mitogen-

activated protein kinases and induce c-fos, independent of Ras and Raf-1 in chinese hamster

ovary cells. Biochemistry 37, 15918-15924.

16. V. Shyamala, H. Khoja, and M. Moghadam (1998) Inhibition of adenylyl cyclase by

chemokines IL-8 and GRO- in chinese hamster ovary cells expressing R1 and R2 receptors. J.

Interferon Cytokine Res. 18, 235-239.

17. C. Caudai, M. G. Padula, I. Bastianoni, P. E. Valensin, V. Shyamala, J. Han, C. A. Boggiano,

P. Almi (1998) Antibody testing and RT-PCR in hepatitis C virus (HCV) infection: HCV-RNA

detection in PBMC of plasma viremia-negative HCV-seropositive persons. Infection 26, 151-

154.

18. C. Reinhard, B. Shamoon, V. Shyamala, and L. T. Williams (1997) Tumor Necrosis factor

alpha induced activation of c-jun N-terminal kinase is mediated by TRAF2. EMBO J. 16,1080-

1092.

19. M. E. Wernette-Hammond, V. Shyamala, M. A. Siani, C. A. Gallegos,, P. H. Feucht, J. Abbott,

G. Reza-Lapointe, M. Moghadam, H. Khoja, J. Zakel, and P. Tekamp-Olson (1996) Receptor

recognition and specificity of interleukin-8 is determined by residues that cluster near a surface-

accessible hydrophobic pocket. J. Biol. Chem. 271, 8228-8235.

20. V. Shyamala, T. H. M. Moulthrop, J. Stratton-Thomas, and P. Tekamp-Olson (1994) Two

distinct human endothelin B receptors generated by alternative splicing from a single gene. Cell.

Mol. Biol. Res. 40, 285-296.

21. F. Damacco, D. Sansonno, J. H. Han, V. Shyamala, V. Cornacchiulo, A. R. Iacobelli, G.

Lauletta, and R. Rizzi (1994) Natural interferon-alpha versus its combination with 6-methyl-

prednisolone in the therapy of type II mixed cryoglobulinemia: a long-term, randomized,

controlled study. Blood 84, 3336-3343.

22. L. J. van Doorn, V. Shyamala, J. H. Han, and G. E. Kleter (1994) HCV RNA detection in

heparinized blood by direct genomic RNA capture onto paramagnetic particles. J. Virol. Meth.

48, 339-341.

23. S. Magrin, A. Craxi, C. Fabiano, G. Florentino, L. Marino, P. Almasio, G. B. Pinzello, U.

Palazzo, M. Vitale, A. Maggio, G. Bucca, F. Gianguzza, V. Shyamala, J. H. Han, and L.

Pagliaro (1992) Serum hepatitis virus (HCV)-RNA and response to alpha-interferon in anti-

HCV positive chronic hepatitis. J. Med. Virol. 38, 200-206.

V. Shyamala 5 7/26/2012

24. J. H. Han, V. Shyamala, K. H. Richman, M. J. Brauer, B. Irvine, M. S. Urdea, P. Tekamp-

Olson, G. Kuo, Q.-L. Choo, and M. Houghton (1991) Characterization of the terminal regions

of hepatitis C viral RNA: Identification of conserved sequences in the 5' untranslated region

and poly(A) tails at the 3' end. Proc. Natl. Acad. Sci. USA 88, 1711-1715.

25. A. J. Weiner, C. Christopherson, J. Eric Hall, F. Bonino, G. Saracco, K. Crawford, C. D. Marion,

K. A. Crawford, V. Shyamala, T. Miyamura, J. McHutchinson, T. Cuypers and M. Houghton

(1991) Sequence variation in hepatitis C viral isolates. J. Hepatology 13, 6-14.

26. R. V. Webster, J. C. Craig, V. Shyamala, G. C. Kirby, and D. C. Warhurst (1991) Antimalarial

activity of optical isomers of quinacrine dihydrochloride against chloroquine-sensitive and -

resistant plasmodium falciparum in vitro. Biochem. Pharmacol. 42, S225-S227

27. V. Shyamala, V. Baichwal, E. Beall, and G. F.-L. Ames (1991) Structure-function analysis of

the histidine permease and comparison with cystic fibrosis mutations. J. Biol. Chem. 266,

18714-18719.

28. R. E. Kerppola, V. Shyamala, P. Klebba, G. F.-L. Ames (1991) The membrane-bound

proteins of periplasmic permeases form a complex. Identification of the histidine permease

HisQMP complex. J. Biol. Chem. 266, 9857-9865. 29. V. Shyamala, and G. F.-L. Ames (1991) Use of exonuclease for rapid polymerase-chain-

reaction-based in vitro mutagenesis. Gene 97, 1-6.

30. V. Shyamala, E. Schneider, and G. F. L. Ames (1990) Tandem chromosomal duplications: Role

of REP sequences in the recombination event at the join-point. EMBO J. 9, 939-946.

29. 31. V. Shyamala, and G. F.-L. Ames (1989) Genome walking by single-specific-primer polymerase

chain reaction: SSP-PCR. Gene 84, 1-8.

30. 32. V. Shyamala, and G. F.-L. Ames (1989) Amplification of bacterial genomic DNA by the

polymerase chain reaction and direct sequencing after asymmetric amplification: application to

the study of periplasmic permeases. J. Bacteriol. 171, 1602-1608.

Selected

Invited

Articles

1. V. Shyamala, and G. F.-L. Ames (1993) Genome walking by Single-Specific Primer Polymerase

Chain Reaction, in Methods in Enzymol. Vol. 217 Part H, pp 436-446. Ed. R. Wu.

2. V. Shyamala, and G. F.-L. Ames (1993) Single-Specific Primer Polymerase Chain Reaction and

Gene walking, in PCR protocols Current methods and applications, Vol. 15, pp 339-348. Ed. B.

White

3. A. J. Weiner, V. Shyamala, J. Eric Hall, M. Houghton, and J. Han (1992) Application of

polymerase chain reaction to hepatitis C virus research and diagnostics, in Diagnosis of human

viruses by polymerase chain reaction technology. pp 86-100.

Poster

Presentation

2000-2012

65th

Annual AABB meeting, 2012, 6th

-9th

October, Boston MA

1. K. Chatterjee, V. Shyamala. Procleix Ultrio Plus Assay Evaluation Experience for Indian donor

population. Transfusion 52,

32nd

Congress of the ISBT, 2012, 7th

-12th

July, Cancun, Mexico

2. V. Shyamala, Karnataka State Government, Bangalore Medical Systems. Public Private

Partnership for Statewide consolidation and Centralized Individual Donation Nucleic Acid

Testing in India: Karnataka State Experience. Vox Sanguinis 103, 77.

40th

Annual Oakridge Conference, 2008, 17th

-18th

April San Jose, CA

3. F. Benahmed, J. Simpson, N. Chakraborty, I. Mielzynska, K. Modarress, T. Hazel, V. Shyamala

A rapid, sensitive, specific assay for the detection of Chlamaydia trachomatis in urine by the

CANARYR assay.

59th

Annual AABB meeting, 2006, 21st -24

th October, Miami Beach, FL

4. Y.-L. Fong, D. Madriaga, V. Shyamala, J. Cottrell, R. Lewis, L. Eudey, G. Crutcher, N. Lelie,

A. Heaton, B. Phelps, D. Chien. Evaluation of Analytical Sensitivity of Chiron Target Capture

HBV DNA Assay for HBV Detection, and Comparison with NGI SuperQuantTM

HBV DNA

Assay. Transfusion 46, 96.

5. S. Kleinman, T. H. Lee, L. Montalvo, L. H. Tobler, S. A. Glynn, D. S. Todd, V. Shyamala, D.

Madriaga, J. E. Kiss, M. P. Busch. Prevalence and Quantitation of Parvovirus B19 DNA Levels

in Blood Donors Using a Sensitive PCR Screening Assay. Transfusion 46, 37.

25th

Annual meeting of American Society of Virology, 2006, 15th

-19th

July, Madison, WI

6. V. Shyamala, B. Hjelle, D. Madriaga, H. Huang, S. Nguyen, D. Chien, B. Phelps, S. Pichuantes.

V. Shyamala 6 7/26/2012

Multiplex detection and quantitation of six subtypes of Hantavirus RNA. Abstract W53-1, p210.

58th Annual AABB meeting, 2005, 15

th -18

th October, Seattle, WA

7. J. Cline, C. Deza, R. Cory, A. Garcia, M. Lewis, A. Broulik, M. Deras, V. Shyamala, S.

Pichuantes, C. Giachetti, J. M. Linnen. Stability of WNV Viral RNA from tissue culture and

blood donor samples in stored blood. Transfusion 45, 149.

8. L. H. Tobler, V. Shyamala, J. Saldhana, C. Cameron, R. Lanciotti, R. Smith, I. Walsh, B.

Munneke, B. H. Phelps, D. Chien, M. P. Busch. West Nile virus (WNV) viral load comparison

study. Transfusion 45, 151.

9. S. Nguyen, V. Shyamala, H. Huang, D. Madriaga, M. Badgett, J. Hedges, C. WalkerPeach, D.

Chien, B. Phelps, S. Pichuantes. Cloning of West Nile virus internal control and nucleotide

fragments spanning the full-length viral genome for production of stable RNA standards.

Transfusion 45, 151.

2005 National conference on West Nile Virus, 8th

-9th

February, San Jose, CA

10. S. Cagliotti, G. F. Robertson, J. McAuley, S. H. Kleinman, L. H. Tobler, H. Kamel, J. M.

Linnen, V. Shyamala, P. A. Tomasulo, M. P. Busch. Screening the blood supply for West Nile

Virus RNA by nucleic acid amplification testing.

11. M. P. Busch, L. H. Tobler, J. McAuley, J. M. Linnen, V. Shyamala, G. F. Robertson, D. J.

Wright, S. H. Kleinman, S. Cagliotti. West Nile virus RNA dynamics and antibody evolution

based on Follow-up of viremic blood donors.

12. L. H. Tobler, V. Shyamala, J. Saldhana, C. Cameron, R. Lanciotti, R. Smith, I. Walsh, B.

Munneke, B. H. Phelps, D. Chien, M. P. Busch. West Nile virus (WNV) viral load comparison

study.

57th Annual AABB meeting, 2004, 23

rd -26

h October, Baltimore, MD

13. V. Shyamala, D. Madriaga, S. Pichuantes, B. Jaitner, D. Chien and B. Phelps. Performance

characteristics of the Validated and Improved qualitative and quantitative Target-Capture PCR

WNV NAT assays. Transfusion 44, 140.

14. V. Shyamala, P. Arcangel, J. Cottrell, D. Coit, A. Medina-Selby, C. McCoin, D. Chien, B.

Phelps. Performance characteristics of the qualitative and quantitative Target-Capture PCR HBV

NAT assay. Transfusion 44, 85.

15. V. Shyamala, J. Cottrell, D. Madriaga, P. Arcangel, M. Hartman, K. Gasuad, D. Chien, B.

Phelps. Quantitation of commercially available nucleic acid amplification Run controls, and

Standards by Target-Capture PCR assay. Transfusion 44, 91.

16. M. Busch, L. Tobler, J. McAuley, J. Linnen, V. Shyamala, G. Robertson, D. Wright, S.

Kleinman, S. Cagliotti. West Nile Virus RNA dynamics and anttibody evolution based on

follow-up of viremic blood donors. Transfusion 44, 2.

17. J. Cline, M. Lewis, W. Wu, S. Miller, A. Broulik, J. Savage, V. Shyamala, M. Cass, C.

Giachetti, J.M. Linnen. Gen-Probe Alternative WNV assay: A TMA-based confirmatory assay

for West Nile Virus. Transfusion 44, 138.

28th congress of the ISBT meeting, 2004, 10

th-15

th July, Edinburgh, UK.

18. V. Shyamala, S. Pichuantes, B. Jaitner, D. Madriaga, P. Arcangel, J. Cottrell, S. Nguyen, H.

Huang, A. Medina-Selby, D. Coit, D. Chien B. Phelps. Performance characteristics of the

qualitative and quantitative Target-Capture PCR WNV NAT assay. Vox Sanguinis, 87, 26.

19. L. H. Tobler, H. Prince, G. Hafner, B. Dille, R. A. Gutierrez, W. Andrews, C. Harrington, V.

Shyamala, J. McAuley, V. Winkelman, S. Cagliotti, M. P. Busch. Relative performance of four

West Nile Virus antibody assays in viremic blood donor specimens. Vox Sanguinis, 87, 65.

XII APISBT, 2003 15th

–18th

November, New Delhi, India

20. V. Shyamala, P. Arcangel, D. Madriaga, D. Chien, and B. Phelps. Detection and Quantitation of

HCV RNA by Bead capture-TaqMan technology.

56th

Annual AABB meeting, 2003, 1st-4

th November, San Diego, CA

21. V. Shyamala, J.Cottrell, P. Archangel, D. Coit, A. Medina-Selby, C. McCoin, J. Turczyn, D.

Chien and B. Phelps. Validation Of Alternative NAT HBV Assay: A Highly Sensitive PCR

Based Assay For HBV DNA. Transfusion. 43, 125.

22. V. Shyamala, S. Pichuantes, B. Jaitner, D. Madriaga, P. Arcangel, J. Cottrell, S. Nguyen, H.

Huang, A. Medina-Selby, D. Coit, C. McCoin, D. Chien, B. Phelps. Detection and Quantitation

of West Nile Virus RNA by the Alternative NAT WNV Assay. Transfusion. 43, 128.

23. B. Jaitner, V. Shyamala, S. Nguyen, H. Huang, Y-L Fong, D. Chien, B. Phelps, S. Pichuantes.

V. Shyamala 7 7/26/2012

Propagation, quantitation, and inactivation of West Nile Virus to support nucleic acid and IgM

assay development. Transfusion. 43, 128.

24. V. Shyamala, P. Arcangel, D. Madriaga, J. Cottrell, J. Linnen, D. Chien, B. Phelps.

Compatibility of ProcleixR-West Nile Virus (WNV) assay in various anticoagulants. Transfusion.

43, 129.

10th

EPFA/NIBSC workshop & SoGAT meeting, 2003, 3rd

-4th

July, Langen, Germany

25. V. Shyamala, S. Pichuantes, B. Jaitner, D. Madriaga, P. Arcangel, J. Cottrell, S. Nguyen, H.

Huang, A. Medina-Selby, D. Coit, C. McCoin, D. Chien, B. Phelps. Use of quantitative NAT

assay to correlate West Nile Virus titration bioassasy (pfu/ml) with genomic copy numbers

(geq/mL).

55th

Annual AABB meeting, 2002, 26th

-29th

Oct. Orlando, FL

26. S. Pichuantes, V. Shyamala, H. Huang, S. Nguyen, D. Madriaga, D. Chien, B. Phelps.

Identification and characterization of nucleic acid positive sera from Indonesian and Chilean

patients with acute hepatitis A infections. Transfusion, 42, 90.

27. V. Shyamala, D. Madriaga, J. Cottrell, S. Pichuantes, D. Chien, B. Phelps. Development of a

Parvovirus B19 nucleic acid quantitative confirmatory assay for use in blood donor screening.

Transfusion, 42, 90.

27th

congress of the ISBT meeting, 2002, 24th

-28th

August, Vancouver, Canada.

28. V. Shyamala, P. Arcangel, J. Cottrell, J. Linnen, C. Giachetti, D. Chien, B. Phelps. Performance

characteristics of hepatitis B virus DNA confirmatory assay for ProcleixR triplex assay. Vox

Sanguinis, 83, 183.

29. V. Shyamala, D. Madriaga, S. Pichuantes, D. Chien, B. Phelps. Performance characteristics of

PCR based Parvovirus B19 nucleic acid testing confirmatory assay for the ProcleixR Parvovirus

B19/Hepatitis A virus assay. Vox Sanguinis, 83, 44.

30. S. Pichuantes, H. Huang, S. Nguyen, A. Gaggerro, M. Pena, C. Larranaga, V. Shyamala, D.

Madriaga, D. Chien, B. Phelps. Identification and characterization of parvovirus B19 from

Chilean clinical specimens. Vox Sanguinis, 83, 54.

31. J. Linnen, A. Umali, A. Broulik, D. Kolk, J. Dockter, S. McDonough, V. Shyamala, J. Cottrell,

P. Arcangel, L. Mimms and C. Giachetti. Effect of donor mini-pool size on closure of the HBV

detection window: A comparison of Triplex TMA to surface antigen detection. Vox Sanguinis,

83, 42.

11th

Regional Western Pacific Congress of ISBT, 2001, 10th

-13th

Nov. Shanghai, China.

32. J. Linnen, M. Ho-Sing-Loy, M. Miyano, V. Shyamala, D. Kolk, A. Broulik, A. Menez, A.

Vaughn, E. Peterson, D. Chien, B. Phelps, L. Mimms, C. Giachetti. Performance of the Chiron

ProcleixR Triplex Assay for simultaneous detection of HIV-1, HCV and HBV.

54th

Annual AABB meeting, 2001, 13th

-17th

Oct. San Antonio, TX.

33. J. Linnen, M. Ho-Sing-Lloy, M. Miyano, D. Kolk, A. Menez, A. Vaughn, E. Peterson, V.

Shyamala, P. Arcangel, D. Chien, B. Phelps. Performance of the TMA Triplex Assay which

simultaneously detects HIV-1, HCV and HBV nucleic acid. Transfusion, 41, 82.

34. L. H. Tobler, J. M. Vargo, K. M. Smith, D. Hirschkorn, J. Heitman, C. Degula, V. Shyamala, D.

Chien, B. Phelps, L. Mimms, M.P.Busch. Sensitivity and Specificity of an HCV supplemental

NAT assay. Transfusion, 41, 83.

35. V. Shyamala, S. Brentano, M. Batranina, S. Pichuantes, D. Madriaga, D. Chien, B. Phelps.

Detection of Parvovirus in human plasma samples by Nucleic Acid Amplification Technology

(NAT) Transfusion, 41, 86.

VIIth

European congress of the ISBT meeting, 2001,15th

-18th

July, Paris, France

36. V. Shyamala, D. Chien, S. Nguyen, N. Lagwinski, D. Madriaga, P. Carmichael, B. Phelps. J.

Heitman, D. Hirschkorn, L. Tobler, and M. Busch. Development and Evaluation of Alternative

NAT assay: a highly sensitive RT-PCR based diagnostic assay for HCV RNA.

37. S. Pichuantes, H. Huang, S. Nguyen, V. Shyamala, D. Madriaga, D. Chien and B. Phelps. PCR

amplification, cloning, DNA sequencing and quantitation of parvovirus B19 from human IgM

positive sera.

AACC meeting, 2000, 16th

-18th Nov, Anaheim, CA.

38. V. Shyamala, D. Madriaga, D. Chien and B. Phelps. A highly sensitive, TMA and PCR dual

amplification assay for the detection of Hepatitis C viral RNA molecules.