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BioGenex Laboratories

48810 Kato Road, Suite 200E, Fremont, California, 94538, United States

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Our Company

BioGenex designs, develops and commercializes molecular pathology systems for Tumor diagnosis, prognosis, precision medicine and life science research. BioGenex’s industry-leading next-generation cytogenetic FISH workflow solution and miRNA system for characterization of Cancer of Unknown Primary (CUP) and undifferentiated tumors are revolutionizing pathology. Proprietary fully-automated molecular pathology workstations from BioGenex are the most advanced systems available globally. BioGenex prides itself on delivering cutting edge technology, years ahead of the competition, providing the finest systems for immunohistochemistry (IHC), in situ hybridization (ISH), Fluorescence ISH (FISH) and in situ PCR. BioGenex systems and product performance are guaranteed: antibodies, probes, antigen retrieval, detection systems, and histology stains. We provide quality systems and are committed to best in class customer care.

Facts and Figures

Mission To become a global molecular medicine company providing
affordable solutions for life science research and personalized
medicine
Founders Krishan L. Kalra, Ph.D., Satya Kalra
CEO Krishan L. Kalra, Ph.D.
Incorporation San Ramon, California, 1981
Industry Tissue and cell-based Tumor diagnostics
Locations Headquarters: Fremont, California, USA
Regional Center of Excellence: Hyderabad, India
Manufacturing Sites: Fremont, California, USA and Hyderabad, India
Agency Office: Shanghai, China
Wholly Owned Subsidiary in Europe: Milan, Italy
Customer Service Centers: Fremont, Hyderabad, Shanghai and Milan
Regulatory Certifications ISO 13485 (2016), ISO 9001 (2015), cGMP, IVD – CE certified
Number of Employees 250+ globally
Product Areas Multiple fully automated molecular pathology workstations
Immunohistochemistry (IHC)
In-situ hybridization (ISH)
Fluorescence in-situ hybridization (FISH)
In-situ PCR
Multiplex stains
MicroRNA and HPV probe system
Flagship Products Xmatrx® systems, i6000™ systems, i500 Plus™, NanoVIP®, Xmatrx® MINI, EZ-Retriever®, IHC primary antibodies, microRNA probes,  IHC/ISH
detection kits
Global Reach 70+ distributors across 47 countries
Customers Pathologists, histotechnologists, reference labs, clinical lab
professionals, pharmaceutical/biotechnology and academic
researchers
Patents 25 US and foreign patents granted
28 US and foreign patents pending

Mission Statement

Mission Statement

Our Core Values

BioGenex has a performance-oriented culture with a customer-centric approach creating a foundation for our continuing success. Out of that strong foundation six business themes emerge – they define who we are and guide every decision we make.

  • Empowerment: Employees at every level of the company make decisions that help improve our products, services, and internal operations.
  • Dedication: Our success is due to the commitment, passion and dedication of our employees, delivered every day.
  • Collaboration: The cornerstone of our work culture is collaboration and teamwork, both between divisions within the company and through reaching out to companies with which we can work together to mutually increase value and develop better systems.
  • Customer Focus: Our top priority is our customers in the biomedical sphere. Every client counts, we build long term relations through excellence, superior product performance, fairness and attentiveness to client requirements.
  • Innovation: Our new products are created by continually challenging ourselves to seek better solutions to complex problems that our customers may face. Innovation is a key driver for our growth.
  • Integrity: We “do the right thing” and believe in being responsive, straight-forward and committed to our customers.

Our History

BioGenex was founded in 1981 in San Ramon, California. The mission was clear, become a global molecular medicine company providing affordable biomedical reagent systems.

Towards this goal, in 1991 BioGenex acquired American Bionetics (ABN) and turned their DNA/RNA reagent business into a profitable venture within six months. Since then, the company has launched a series of automated staining systems and a full suite of innovative histology products.

Today, BioGenex is a global market leader in molecular pathology providing customer-centric solutions for complete automation of cell and tissue staining. Through proprietary cutting-edge technologies, the company has transformed the practice of slide-based staining performed in modern molecular pathology laboratories.

Early, affordable and accurate diagnosis at the molecular level has resulted in a higher quality of life for cancer patients. For example, revolutionary immunotherapy PDL1 checkpoint inhibitors for lung cancer treatment are prescribed on the basis of an IHC biomarker test. BioGenex takes pride in making a difference through its innovative products and superior customer service.

BioGenex Timeline

2010s
2015 – Xmatrx® offered in situ PCR and miRNA assays
2015 – Dedication of 100,000 sq.ft. Regional Center of Excellence in Hyderabad, India
2014 – Introduction of Xmatrx® ELITE, NANO and MINI systems
2014 – BioGenex S.R.L., a wholly owned subsidiary of BioGenex, established in Milan, Italy
2014 – Introduction of multiple Nucleic Acid Detection (NAD) products
2010 – Agency office open in Shanghai, China

2000s
2009 – Abbott and BioGenex extended Xmatrx® technology co-development and distribution agreement
2009 – Introduction of eFISHiency, fully automated FISH system powered by Abbot
2006 – Hyderabad, India subsidiary established
2005 – Introduction of Super Sensitive Polymer-HRP detection system
2005 – Introduction of Xmatrx® staining system
2004 – BioGenex entered agreement with Abbott to co-develop FISH automation
2001 – Introduction of i6000™ staining system

1990s
1999 – Introduction of special stain kits to OptiMax Plus staining system
1996 – Introduction of Advanced OptiMax Plus staining system
1994 – Introduction of first generation of OptiMax Plus staining system
1994 – Introduction of DNA probe product line for in situ hybridization
1991 – Acquisition of American Bionetics (ABN) was completed
1990 – Introduction of MultiLink IHC detection system

1980s
1989 – Introduction of BioGenex antigen retrieval products
1981 – Company founded in San Ramon, California

Our Commitment

BioGenex is committed to the design, manufacture, and distribution of best in class quality products. This is reflected in:

• Meeting or exceeding internal and external customer needs
• Meeting or exceeding international (ISO) quality standards and country-specific regulatory requirements
• Quality by design (QbD) and continuous improvement implemented by our employees