Summary
Overview
Work History
Education
Skills
Timeline
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Sundaresh Brahmasandra

Ann Arbor,USA

Summary

Visionary executive with a proven track record in leading global R&D, driving innovation strategy, and executing high-impact product development diagnostics. Expertise in building and leading high-performing cross-functional teams, securing regulatory approvals and delivering transformative solutions designed to enhance patient outcomes. Adept at leveraging emerging technologies, forging strategic partnerships, and fostering a culture of innovation to drive business growth and market leadership

Overview

25
25
years of professional experience

Work History

VP Assay R&D and Clinical Affairs

Luminex Corp
02.2023 - Current
  • Company Overview: Luminex is on a mission to empower labs to obtain reliable, timely, and actionable answers, ultimately advancing health by offering a wide range of solutions across diverse markets including clinical diagnostics, pharmaceutical drug discovery, biomedical research, genomic and proteomic research, and food safety
  • Led global R&D and Clinical Affairs teams, translating emerging market trends and technological advancements into high-impact diagnostic solutions across four different product platforms spanning targeted, point of care, and highly multiplexed diagnostics
  • Spearheaded international R&D initiatives, securing four FDA 510(k) clearances and the first IVDR certification in Europe within 12 months
  • Fostered cross-functional collaboration between clinical, marketing, and scientific teams to significantly improve operational efficiencies while ensuring alignment between innovation priorities and business objectives
  • Assisted in critical diligence for partnerships and M&A activities, contributing to strategic growth
  • Luminex is on a mission to empower labs to obtain reliable, timely, and actionable answers, ultimately advancing health by offering a wide range of solutions across diverse markets including clinical diagnostics, pharmaceutical drug discovery, biomedical research, genomic and proteomic research, and food safety

COO

Strata Oncology
01.2022 - 09.2022
  • Company Overview: Strata Oncology is on a mission to accelerate the impact of precision medicine for patients with cancer through the development of innovative and effective diagnostic tests and large-scale clinical validation
  • Transformed innovative oncology research into commercial diagnostic solutions, launching Precision Oncology 2.0 with personalized therapy and MRD tests
  • Optimized clinical lab operations, achieving a reduction in turnaround time and re-run rates
  • Cultivated an innovation-driven culture, mentoring teams in bioinformatics, clinical lab operations, and product management
  • Strata Oncology is on a mission to accelerate the impact of precision medicine for patients with cancer through the development of innovative and effective diagnostic tests and large-scale clinical validation

Independent Consulting

Hollow Oak Consulting
03.2021 - 12.2021
  • Provided product development and strategic consulting services to companies in the medical device and diagnostics sector
  • Consultant, Quotient Bio (QTNT) – Led an international cross-functional team in the feasibility evaluation and definition of a multi-modal microarray-based integrated diagnostic system for blood screening applications
  • Consultant, Gregor Diagnostics – Provided critical development analysis of a multi-modal in vitro diagnostic product for prostate cancer detection, stratification & active surveillance; Continue to serve as member of the Board of Directors

VP/Site Head Operations & Product Development

NeuMoDx, a QIAGEN Company
09.2020 - 03.2021
  • Company Overview: QIAGEN is the leading global provider of Sample to Insight solutions that enable customers to gain valuable molecular insights from samples containing the building blocks of life
  • Served as the technical and operational interface for post-merger transition activities
  • Led site expansion to meet explosive market demands implementing significant workforce and facility expansions during a pandemic putting organization on track to achieve upwards of $150MM in revenue in 2021
  • Championed product development & commercialization strategy and worked in close partnership with broader QIAGEN organization to ensure accomplishment of strategic initiatives
  • QIAGEN is the leading global provider of Sample to Insight solutions that enable customers to gain valuable molecular insights from samples containing the building blocks of life

President & COO

NeuMoDx Molecular
07.2012 - 09.2020
  • Company Overview: NeuMoDx Molecular Inc developed vastly superior solutions for molecular diagnostic (MDx) testing in hospital and reference lab settings
  • The company was acquired by QIAGEN for an enterprise value of $300+ MM
  • Drove the conceptualization and commercialization of novel diagnostic platforms bringing the ‘simplicity of clinical chemistry to molecular diagnostics’ and resulting in a $300+ MM acquisition by QIAGEN
  • Secured over $77 million in venture financing, propelling the company from early-stage development to commercial launch
  • Defined and executed innovation strategy for NeuMoDx 288 and 96, bringing the simplicity of clinical chemistry workflows to molecular diagnostics
  • Co-led menu development strategy, integrating high-growth esoteric test development and strategic licensing to expand test menus across viral load monitoring, transplant testing, and STI detection resulting in the launch of 16 CEIVD assays and three FDA cleared assays
  • Built and scaled high-performing, cross-functional R&D teams, fostering a culture of innovation, collaboration, and accountability to drive high-impact diagnostic solutions
  • Developed and executed financial strategy aligning R&D investment with innovation priorities, ensuring high ROI and sustainable growth
  • NeuMoDx Molecular Inc developed vastly superior solutions for molecular diagnostic (MDx) testing in hospital and reference lab settings
  • The company was acquired by QIAGEN for an enterprise value of $300+ MM

President

Life Magnetics
04.2011 - 06.2012
  • Company Overview: Life Magnetics, Inc., pioneered the development of a novel, proprietary platform for label-free cell-based analysis
  • Recruited into organization to provide management and operational leadership for early product development team
  • Licensed enabling IP from the university tech transfer office and raised Series A financing
  • Researched and identified potential needs across mammalian and bacterial cell analysis markets
  • Re-defined initial product strategy as well as business model
  • Life Magnetics, Inc., pioneered the development of a novel, proprietary platform for label-free cell-based analysis

VP R&D, Assay Development

BD Diagnostics Systems
11.2009 - 03.2011
  • Company Overview: BD is a global leader of products used for diagnosing infectious diseases in the clinical market to screen for microbial presence, growth, and identification of organisms, as well as bacterial antibiotic susceptibility
  • Served as key technical liaison for knowledge transfer after the acquisition
  • Led internal test menu development on the BD MAX platform as well as validation of next generation BD MAX platform
  • Championed the strategy of menu extension by harnessing the power of partnerships leading to significant and rapid menu acceleration on the BD MAX platform
  • BD is a global leader of products used for diagnosing infectious diseases in the clinical market to screen for microbial presence, growth, and identification of organisms, as well as bacterial antibiotic susceptibility

VP Product Development & Co-Founder

HandyLab Inc.
01.2000 - 11.2009
  • Company Overview: A University of Michigan spin-off focused on the development of next generation molecular diagnostic platforms and tests based on proprietary nucleic acid extraction technology coupled with an innovative microfluidic real-time PCR module
  • The company was acquired by BD in Nov 2009 for an enterprise value of $283MM
  • As a founding team member, led the end-to-end innovation cycle—from concept to commercialization—of a fully automated molecular diagnostic system integrating nucleic acid extraction, real-time PCR, and microfluidics
  • Directed company-wide innovation and product strategy, leading cross-functional teams spanning R&D, product development, manufacturing, quality, clinical & regulatory affairs, and site operations
  • Cultivated a high-performance, innovation-driven culture by integrating market insights, regulatory pathways, and commercialization strategies to accelerate product launches and drive sustained business growth
  • Secured FDA 510(k) clearance and scaled commercialization efforts, positioning HandyLab for a $283M acquisition by BD, where the system became the thriving BD MAX platform
  • Secured and led high-impact, federally funded innovation initiatives (NIH, NIST, DoD) driving cutting-edge advancements in microfluidic-based diagnostics and detection technologies
  • Led high-impact product development initiatives in collaboration with global industry leaders including Pfizer, Dupont Qualicon, Monsanto, and Digene (QIAGEN)
  • Drove strategic partnerships that accelerated technology adoption, expanded diagnostic capabilities, and enhanced commercial viability of novel molecular testing solutions
  • A University of Michigan spin-off focused on the development of next generation molecular diagnostic platforms and tests based on proprietary nucleic acid extraction technology coupled with an innovative microfluidic real-time PCR module
  • The company was acquired by BD in Nov 2009 for an enterprise value of $283MM

Education

Ph.D. - Chemical Engineering

University of Michigan
Ann Arbor, MI
01-2001

Skills

  • Technology Strategy & Leadership
  • Innovation & Commercialization in Diagnostics
  • Advanced Molecular Technologies (qPCR, NGS, Microfluidics)
  • Regulatory Expertise (FDA, CE-IVD, IVDR)
  • R&D Portfolio Management
  • Business & Market Strategy
  • Strategic Growth & M&A
  • Cross-Functional Team Leadership
  • Scaling Global R&D & Operations

Timeline

VP Assay R&D and Clinical Affairs

Luminex Corp
02.2023 - Current

COO

Strata Oncology
01.2022 - 09.2022

Independent Consulting

Hollow Oak Consulting
03.2021 - 12.2021

VP/Site Head Operations & Product Development

NeuMoDx, a QIAGEN Company
09.2020 - 03.2021

President & COO

NeuMoDx Molecular
07.2012 - 09.2020

President

Life Magnetics
04.2011 - 06.2012

VP R&D, Assay Development

BD Diagnostics Systems
11.2009 - 03.2011

VP Product Development & Co-Founder

HandyLab Inc.
01.2000 - 11.2009

Ph.D. - Chemical Engineering

University of Michigan
Sundaresh Brahmasandra