Legacy Infectious Disease Product Portfolio
Prior to shifting our focus to COVID-19 testing in February 2020,
we had established our company as a leading provider of diagnostic
tests for infectious diseases with a broad portfolio of infectious
disease products. We refer to our infectious disease products,
other than the DPP COVID-19 System, as our legacy products. We
expect to generate an immaterial amount of revenue from our legacy
products for the foreseeable future, while we continue to focus on
the manufacture and commercialization of the DPP COVID-19 System.
Thereafter, however, we intend to recommence the development,
marketing, manufacture and sale of the legacy product portfolio
consistent with market demand.
Our legacy infectious disease products are based on our DPP
technology. They require only a single drop of blood from the
fingertip and provide results in approximately 15 minutes. These
enhanced sensitivity and
when used with our Micro Reader,
numerical results processed in approximately 15
Our legacy products include both stand-alone and multiplex tests
for sexually transmitted infectious diseases such as HIV and
Syphilis. We have sought to address the global concerns related to
HIV and Syphilis co-infection through the development of a novel,
multiplex test for both HIV and Syphilis. We developed a DPP
HIV-Syphilis multiplex test and received regulatory approvals
covering a number of international markets, including Brazil,
Europe, Malaysia and Mexico.
Our legacy products also include tests for selected fever and
tropical diseases such as Chagas, Ebola, Leishmaniasis and Zika.
The market for lateral flow tests for mosquito-borne diseases
includes established markets for diseases such as Dengue and
Malaria. There are also a number of emerging markets for lateral
flow tests for infectious diseases such as Burkholderia,
Chikungunya, lassa, leptospirosis, Marburg, Rickettsia and Zika.
Our legacy products in development include tests using our DPP
platform to detect all of the aforementioned fever and tropical
diseases, as stand-alone or multiplex tests.
Research & Development Services
Our commercially available products employ either our proprietary
DPP technology or traditional lateral flow technology. In recent
years, we have, while concurrently developing our own products,
executed a strategy to leverage DPP intellectual property, as well
as our scientific and operational expertise, through our Research
& Development Services program of collaborative projects.
Research & Development Services develops tests for third
parties using our DPP platform and, in limited cases, other
platforms in projects that we believe have the potential to create
value for the rest of our business. Research and development, or
R&D, costs related to these collaborations are fully funded by
our collaborators. We believe that, in addition to providing
revenue to support our R&D organization, these activities
further validate the DPP platform’s ability to provide superior
diagnostic performance compared with products that utilize
traditional lateral flow technology. The projects also expand the
know-how of our R&D team, which we seek to leverage in the
development of our own products.
Examples of projects performed by Research & Development
Services include a biomarker development project agreement entered
into with AstraZeneca plc in October 2017 in which we use both our
DPP and optical analyzer technologies, and a potential
companion/compatible diagnostic test being developed in
collaboration with Shire Human Genetic Therapies, Inc. a subsidiary
of Takeda Pharmaceutical Company Limited.
We believe leading global healthcare organizations and others have
chosen to collaborate with us based on our deep scientific
expertise with our DPP technology platform and capabilities, our
successful record of developing DPP tests with a diverse set of
collaborators, including global commercial companies, governments
and non-governmental organizations, and our extensive experience in
obtaining regulatory approvals from various regulatory authorities
in the United States, Brazil , the European Union and Mexico.