Modality Dx
- Industry
- Medical Diagnostics
- Founded Year
- 2008
- Headquarters
- 2345 NE Overlook Dr. Suite #140, Hillsboro, OR 97006
- Employee Count
- 21
Key People
- Srinivasa R. Nagalla - President and Chief Executive Officer
- Charles Roberts - Vice President and Chief Science Officer
- Paturi V. Rao - Co-Founder
- Sunil Hazaray - Chief Commercial Officer
- Barbara Chiapuzio - Chief Financial Officer
- Dave Gunderson - Executive Vice President
- Steven Kazmierczak - Vice President and Laboratory Director
Assessment
- Team
-
Aspect: Multiple successful MedTech entrepreneurs
Summary: The leadership team comprises experienced professionals with successful backgrounds in medical diagnostics and biotechnology.
Dr. Nagalla, the CEO, previously founded ProteoGenix, which was acquired by Hologic, Inc. Dr. Roberts has over 25 years in diabetes research and has authored over 250 scientific papers. Their combined expertise provides a strong foundation for the company's endeavors.
- Clinical Need
-
Aspect: Very Strong
Summary: The company's focus on non-invasive, point-of-care diagnostics addresses significant unmet needs in maternal health and diabetes management.
Preeclampsia and gestational diabetes are major concerns in maternal health, and early detection can significantly improve outcomes. Similarly, non-invasive monitoring of diabetes can enhance patient compliance and management. DiabetOmics' products like Lumella and Glucema directly cater to these needs.
- Competition
-
Aspect: Somewhat crowded
Summary: The diagnostics market is competitive, but DiabetOmics' non-invasive, point-of-care solutions offer differentiation.
Major players in the diagnostics field offer various solutions, but DiabetOmics' focus on non-invasive, rapid tests provides a unique value proposition. However, market penetration will require strategic positioning and partnerships.
- Technical Challenge
-
Aspect: Moderate
Summary: Developing accurate, non-invasive diagnostic tests presents moderate technical challenges.
Non-invasive diagnostics must achieve high sensitivity and specificity to be clinically useful. While challenging, the company's existing products suggest a capability to meet these standards.
- Patent
-
Aspect: Strong
Summary: The company holds several key patents on biomarkers for clinical diagnostics.
Dr. Nagalla is the lead inventor on several patents related to biomarkers, which can protect the company's innovations and provide leverage in the market.
- Financing
-
Aspect: Medium
Summary: The company has raised approximately $15.2 million over multiple funding rounds.
Funding from investors like Ventureast and Rogue Venture Partners indicates confidence in the company's potential. Continued financial support will be essential for scaling operations and market penetration.
- Regulatory
-
Aspect: 510k/PMA
Summary: The company has achieved ISO 13485:2016 certification, indicating compliance with international quality standards.
ISO certification demonstrates the company's commitment to quality management systems, which is crucial for regulatory approvals and market acceptance.
Opportunity Rollup
- Odds of Success
- 3.55
- Peak Market Share
- 4.8
- Segment CAGR
- 1.9%
- Market Segment
- In Vitro Diagnostics
- Market Sub Segment
- Point-of-Care Testing
| Year Post Launch | Market Penetration (%) |
|---|---|
| 1 | 0.24 |
| 2 | 0.72 |
| 3 | 1.68 |
| 4 | 3.36 |
| 5 | 4.80 |
Key Takeaway
DiabetOmics, with its experienced leadership and innovative non-invasive diagnostic solutions, is well-positioned to address significant clinical needs in maternal health and diabetes management. However, navigating a competitive market and ensuring regulatory compliance will be critical for its success.