East-West Diagnostics/Theranostics, LLC
Services
Based in the U.S., the principal of East-West Diagnostics/Theranostics, LLC (EW) is also familiar with the Japanese clinical laboratory and IVD market, working with Japanese universities and hospitals. EW introduces technologies from the U.S., EU and South Korea to Japanese manufacturers and distributors. EW provides marketing analysis for Japanese IVD companies interested in entering the U.S. market. EW has supported an U.S. IVD company in a regulatory submission in Japan including setting up the clinical studies and responding to technical questions from the PMDA. EW has also supported a Japanese company in a FDA regulatory submission. Other services include:
- Market research
‐ Business development
‐ Technology assessment
‐ Strategic marketing
‐ Scientific manuscript translations
- CAP accreditation support activities
Education
1973: University of California, Berkeley,
BA Bacteriology
1979: San Francisco State University,
MS Clinical Laboratory Science
1989: Golden Gate University, MBA
1997: University of California, Berkeley,
MPH, Infectious Diseases
2000: University of California, Berkeley,
DrPH, Infectious Diseases
Licenses and certification
1975: Clinical Laboratory Scientist License,
California
1975: ASCP Clinical Laboratory License
2011: American Board of Medical Microbiology
（ABMM) Certification
Publications
Lead author (11)
Takahashi, H., S. A. Norman, E. L. Mather, and
B. Patterson. 2008. Evaluation
of the NanoChip 400 System for detection
of Influenza A and B viruses,
respiratory syncytial and parainfluenza viruses. J.
Clin. Microbiol. 46:1724-1727.
Co-author (14)
Kanesaka I, Katsuse KA, Takahashi H, Kobayashi I.
2022. Evaluation of a biopolar
ionisation device in inactivation of antimicrobial
resistant bacteria, yeast,
Aspergillus and human coronavirus. Journal of
Hospital Infection.
In 2020, the principal published a book
(Japanese) in Japan that covers the U.S.
IVD market, health care and regulatory system.
Work history
1976: Kaiser Hospital, San Francisco
Clinical Laboratory Scientist, Bacteriology
1979: Kaiser Northern California
Regional Laboratory
1979: Established the parasitology, mycology and
mycobacteriology sections
1983: Established the virology section
1990: Established molecular infectious disease and
infectious disease Immunoassay sections
2001: Becton Dickinson Japan
Director of the technical team and company
laboratory
2006: Stanford University Medical Center
Clinical laboratory business development
director
2008: Established East-West
Diagnostics/Theranostics, LLC
A consulting company with a focus in
clinical laboratory diagnostics
2014: Appointed visiting professor, Toho University
Division of Nursing, Infection Control and
Prevention Research
Professional Profile and Experience
Hiroshi Takahashi
East-West Diagnostics /Theranostics, LLC
Principal
