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Gypsy Bay Genomics, Inc.

Molecular Pap test to detect cervical cancer caused by HPV

Presenter: Jenna Baker


Monday, Dec. 16, 2019

Embassy Suites, Chesterbrook, Pennsylvania (directions)




Gypsy Bay Genomics (GBG) is a Department of Defense spinout licensed in Delaware to commercialize the Molecular Pap, a novel diagnostic and prognostic test that detects cervical cancer caused by the Human Papilliomavirus (HPV). The culmination of ten years of DOD-funded research with multiple human studies, our genomic test provides numerous competitive advantages:  1) early revenue generation,  2) de-risked IP,  3) built-in pipeline generation,  4) money-saving DoD support,  5) universal HPV genotyping,  6) epigenetic biomarkers,  7) predictive analytic software, and 8) can be developed using common laboratory equipment, resulting in a less expensive test. 


Customer problem:

The current FDA approved HPV DNA tests are for qualitative detection of virus infection (either positive or negative). These HPV tests have low positive predictive value for early indicators of cervical cancer and are generally used in conjunction with cytological testing (PAP smear).  This can lead to unnecessary additional testing and overly-aggressive treatment strategies, and generate unnecessary patient distress in the event of a false-positive result. False-negative results can lead to a failure to detect cervical cancer in sufficient time to stop disease progression. 



Leveraging universal HPV genotyping and novel epigenetic profiling, the Molecular Pap can identify the specific HPV type infecting a patient, differentiate between grades of cervical cancer by molecular signature, and detect emerging HPV genotypes for which no current diagnostic test exists. Preliminary research indicates the Molecular PAP provides greater accuracy and more personalized test results than the current standard of care.  Additionally, the laboratory equipment required to perform the Molecular PAP is more broadly available than specialized cytology labs and can extend affordable cancer screening into global markets where it is not routinely available.


Market Overview:  

In the US, 79 million men and women are currently infected with HPV and roughly 14 million new cases arise each year, resulting in $8B in direct medical expenses. Incidence of select HPV cancers (oral, anal, penile) are significantly rising. 


Business Model:  

GBG is set to enter the Research Market in Q120 to distribute the molecular diagnostic test to epidemiologists, national laboratories, product developers, and basic researchers. In parallel, GBG plans to file with regulatory authorities by Q420 to begin clinical trials for the IVD. Plans are underway to extend the screening platform for the detection of other HPV related cancers with large market potential (anal, oral, vulva, vaginal and penile).



3 Major Issues


  1. Should GBG focus on offering the cervical cancer screening at a centralized laboratory (e.g., Cologuard), partner exclusively with a diagnostics company (e.g., proprietary platform), or offer proprietary reagents to all interested distributors?
  2. De-identified results will be fed into bioinformatic software to help improve predictive analytics of molecular diagnostics and build a real world database for our global HPV platform.  Data accumulation will begin with the RUO (Research Use Only) and be extended after commercial launch.  Should this be considered a separate business or integrated into the value proposition?
  3. The Molecular PAP will provide the benefit of HPV tests and the additional results from the biomarkers that will eventually eliminate most need for reflex cytology. How should GBG target the market (value pricing with benchmark to HPV test or premium pricing with benchmarking co-testing)? 





6:30 - Cocktails & Dinner (Cash bar and special 2-entree buffet menu)

7:45 - Jenna Baker, , PhD, Founder & CEO of Gypsy Bay Genomics, will deliver "Elevator" Pitch to the Group

8:00 - A Panel will address three major issues crucial to helping the Company reach the next level.

9:00 - Open discussion: members and guests




Available Media

Please note: All information obtained here is the property of those presenting and should not be copied or duplicated without written consent.



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Gypsy Bay Webcast - 12/16/19


The webcast recording of the PCCI meeting is posted on the PCCI website a few days after the event.

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