Overview

Preora Diagnostics is a medical technology company focused on commercializing low-cost, minimally invasive, highly sensitive and highly specific screening tests for the most common types of solid-tumor cancers. The tests are designed to be simple enough to be performed in a primary care physician’s office without any extensive preparation.

The entire Preora team approaches each day with a clear mission: save lives by revolutionizing early cancer detection. Our screening tools use proprietary technology – Partial Wave Spectroscopy (PWS) Nanocytology – to detect cellular changes at the nanoscale level. PWS-based tests may aid in risk assessment and early detection of cancers in high-risk, asymptomatic patients. Tests results may provide physicians with information that they need to encourage patients to comply with national screening guidelines for lung, colorectal and other solid-tumor cancers.

Revolutionizing Early Cancer Detection

Preora President & CEO John Hart provides a brief summary of the company’s mission, vision and foundational scientific principles

Leading with Lung Cancer

Due to the lack of a convenient, cost-effective screening test and therefore limited early detection, lung cancer is the leading cause of cancer mortality in the United States, with more than 150,000 deaths a year. To address this unmet medical need, Preora is working with clinical collaborators in Chicago and Boston to complete and publish clinical results in preparation for market introduction of its first screening test for lung cancer.

lung-graphic

The Company is working with clinical collaborators at North Shore Health system and Northwestern Healthcare in Chicago, Boston University Medical Center, and New York University Health system to complete and publish clinical results in preparation for market introduction. We will partner with leading advocacy groups (e.g., American Cancer Society, American Lung Association, American Academy of Family Physicians, etc.) to raise awareness of and demand for the availability and effectiveness of the test.

The Preora lung cancer screening test requires a simple cheek swab to collect buccal cells that are then placed in solution and shipped to the Preora lab for testing. The cheek cells are deposited on a slide and then processed and analyzed in Preora’s lab by the Company’s proprietary, automated Partial Wave Spectroscopy (PWS) Nanocytology microscope. PWS Nanocytology software generates test outcomes, sending a corresponding HIPPA-compliant report to the prescribing PCP for review and consideration of next steps.

“A new test that could provide me with the information I need to encourage my patients to comply with national cancer screening guidelines, while also reducing exposure to radiation, would have a significant positive impact on early cancer detection.”
David S. Wilson, MD, FCCP; President/CEO Respiratory Critical Care Associates

Management

John Hart

President and CEO, Board Member

35-year career with Baxter, Allegiance, and Cardinal Health. Involved in bringing new drug-delivery-platform technologies and over 100 new product codes to market.

Hariharan Subramanian, PhD

Chief Technology Officer

Research Assistant Professor, Biomedical Eng. Dept., Northwestern University, Evanston, IL. One of the lead developers of the PWS technology platform.

Advisory Team

Vadim Backman, PhD

Chairman of the Board

Professor of Biomedical Engineering, Professor of Biophotonics, Northwestern University. Leader, Cancer and Physical Sciences Program at the Robert H. Lurie Comprehensive Cancer Center.

Hemant Roy, MD

Board Member, Chair of the Advisory Board

Professor of Medicine, Chief, Section of Gastroenterology; Boston University Medical Center Boston.

Stuart Cornew

Board Member

Founder and Managing Director of AnswerMine. Chairman of Northwestern University’s Chemistry of Life Processes Institute Executive Board.

Bob Altman

Board Member

Previously, senior executive at Pinnacle Biologics (the U.S.-based subsidiary of Concordia Healthcare), Marathon Pharmaceuticals, Astellas Pharma and Abbott Laboratories. Current board member of Toltec Pharmaceuticals and Output Medical.

Steve Ducommun

Legal and Intellectual Property

Partner at the Chicago law firm Perkins Coie; counsels Preora on a broad range of legal and IP issues

Colleen Hittle

Regulatory

Managing Director, Leader of Navigant’s Regulatory Services Group; counsels Preora on regulatory affairs strategies

Company History

The opening chapter of the Preora Diagnostics story begins with a young boy’s wish to become a physician to help people. Years later, while enrolled in the Harvard-MIT Health Sciences and Technology program, Vadim Backman started to “think big,” transforming his childhood goal to become a doctor into a dream of saving millions of lives through the development of advanced technology. To realize this dream, Dr. Backman came to Northwestern University.

Dr. Backman believed that a team of experts that shared his vision could have as significant an impact on several cancer types as the Pap smear has had in cervical cancer. To realize his dream of enhancing the early detection of cancer, he created the Backman Photonics Laboratory at Northwestern University in 2008, which lead to a partnership with Dr. Hariharan Subramanian and their co-creation of their proprietary PWS Nanocytology technology platform.

Recognizing their shared values and their ability to collaborate effectively, Drs. Backman, Subramanian and Hemant Roy formed NanoCytomics LLC in 2011. The company’s name connotes its focus on studying cells at the nanoscale level. Their resulting research efforts spawned a new field, nanocytology, which today is the foundation for the company’s new product development efforts to revolutionize early cancer detection. NanoCytomics is the exclusive licensee of product candidates generated by the PWS Nanocytology technology platform.

In 2015, NanoCytomics created a new company, Preora Diagnostics Inc., as the exclusive licensee of NanoCytomics’ cancer screening tests. Led by President and CEO John Hart, Preora’s vision is to be the company that commercializes screening tests uniquely suited to be the first step in a two-tiered approach to detecting solid-tumor cancers, and to do so around the world.

Market Opportunity

market-opportunity
Approximately 12 million Americans are at high risk for lung cancer (ages 55-80 with a history of smoking). Millions more have hereditary concerns and/or have been exposed to other environmental conditions (e.g., radon, industrial chemicals) that are known to increase the risk of lung cancer, representing a total market size of approximately $2 billion/year. International markets also provide significant revenue opportunities, especially Europe, China, and India, where smoking and environmental risks are high.

Preora’s approach meets the criteria for an effective pre-screening test in that it is:

  • Effective: High sensitivity (low false negatives) and high specificity (low false positives)
  • Low Cost: Approximately $150/test (est.)
  • Easy to Use: PCP office test – Cheek-swabbed cells deposited in a liquid vial, shipped to Preora lab for evaluation

Intellectual Property

intellectual-property
The Company has six issued patents and has filed non-provisional applications, which together cover all key aspects of the platform, from the principles of technology to specimen processing to clinical use. The Company anticipates filing additional patents on new cell collection and slide processing technologies which are currently under development.

Regulatory & Reimbursement Strategy

The Company intends to enter the market as a Laboratory Developed Test (LDT) with claims of “…providing additional information to physicians so they can make a more informed decision as to the next step in diagnoses.” Preora is planning for the commencement of a robust clinical study and the construction of an operating lab to support LDT status. The Company expects to partner with a significant commercial entity with domestic and international market reach to help fund the additional clinical studies required to broaden regulatory claims.

The Company is also working with consultants to prepare for meetings with the American Medical Association (AMA) and the Centers for Medicare and Medicaid Services (CMS) to review coverage strategy/opportunities. With health care coverage plans migrating to support preventive and early-diagnostic testing, we expect the Preora test will become part of the annual physical exam for people at high risk of lung cancer. Preliminary market research indicates that many individuals with high-deductible plans would be willing to pay out of pocket expenses of $150 for an effective pre-screening cancer test.