DNA Software: The Difference is in the Design

DNA Software, Inc. (DNAS) is a Michigan-based life science company located in Plymouth, MI at the Michigan Life Sciences Innovation Center (MLSIC) facility. DNA Software offers state-of-the-art software for the design of nucleic acid diagnostics, particularly in the polymerase chain reaction (PCR) market.

Before COVID, PCR wasn’t necessarily the household term it has become today. Awareness for PCR rapidly increased throughout the pandemic as PCR based testing for disease is recognized as the “gold standard” in diagnostics. Suddenly an acronym that was foreign to most was in the daily news, on the bottom of the sports-ticker and became a new requirement for travel. At a $7B market size pre-COVID in 2019, molecular diagnostics today is a $25B industry in 2024 which will grow to greater than $50B in 2030.

DNA Software has always been uniquely positioned in the PCR and molecular diagnostics space, however, now finds itself at an inflection point in its 23rd year of business. Demand for PCR-based testing from healthcare providers continues to grow. This includes multiplexed PCR based detection methods as multiplex based testing enables many samples to be tested at once to save costs. Multiplexed PCR assays allow for the most accurate detection of many diseases, lowering costs and increasing throughput. “All multiplex roads in molecular diagnostics run through DNA Software” shares Dr. John SantaLucia, founder and CEO of DNA Software, Inc. “Whether licensing software, our services , or our assays, our expertise shines when designing multiple PCR tests simultaneously because of the foundational science discovered at my academic lab at Wayne State University (Detroit,MI) where I was a professor for nearly 30 years”.

PCR tests are not only limited to COVID and respiratory illness (such as FluA/FluB/RSVA/RSVB) but include everything from the flu and strep throat. This also includes a multitude of panels including UTIs (urinary tract infections), STIs (sexually transmitted infections) GI (gastrointestinal) along with many other commonly ordered pathogen tests. Customer benefits include detecting many pathogens simultaneously, superior results and limit of detection while decreasing per sample test costs along with a higher sample throughput.

DNA Software has provided “best in class” software to leading biotech firms for FDA approved molecular diagnostics. DNAS worked on custom projects with Moderna to characterize modified nucleotide behavior in the mRNA vaccine delivery. During the onset of COVID, the Department of Defense contacted DNAS to design SARS-CoV-2 assays along with biodefense panels. DNAS has long been recognized as an industry leader for its software, R&D and client services and was the 2023 recipient for the Frost & Sullivan “best in class” award for multiplex solutions provider in the industry.

PCRAssays, a DNA Software company

Through a “COVID Awakening”, DNA Software realized that R&D teams throughout the molecular diagnostics field relied on its science, algorithms, software and models for diagnostic design. Having provided software and client services to a “who’s who” list of biotech organizations including BD, Cepheid, Roche, Qiagen, Hologic, Thermo Fisher and Eli Lilly, DNAS moved to the MLSIC facility in late 2020 to manufacture its own line of PCR kits and assays through its new subsidiary, wwww.pcrassays.com. DNAS is uniquely positioned to leverage its technology to build high performing multiplexed PCR assays.

To capture more of the value they create, DNAS launched a new brand, PCRassays, which directly provides multiplexed RUO qPCR kits. These assays detect human pathogens, food borne pathogens, and are used for wastewater surveillance and research-based applications. PCRassays offers flexible multiplex configurations. Through its unique automated design platform (DNA Software), these “plug and play” assays are adaptable for ever changing market dynamics. PCRassays has transformed the firm’s digital assets into physical assets as the organization now ships reagents throughout the world for a variety of applications.

Spotlight on Michigan based partnerships

The DNAS subsidiary PCRassays has grown with several Michigan based partners. This includes the State of Michigan Department of Health and Human Services (DHHS) (Lansing, MI) to develop a novel Hepatitis A assay. Recent outbreaks in MI of Hepatitis A brought about the need for the rapid development of a qPCR-based assay and the State of MI elected to work with DNAS and PCRassays for their expertise in the development of such an assay.

The portfolio of infectious disease qPCR assays has grown to nearly 200 pathogens, >50 in multiplex. PCRassays has focused on growing channel partners and distribution to increase its adoption. Michigan based partnerships include enzyme manufacturer Fortis (Formerly Empirical Biosciences in Grand Rapids, MI). Fortis custom formulated an enzyme that optimizes PCRassays kits and its product performance overall.

DNAS has also partnered with Cayman Chemical, (Ann Arbor, MI) a global leading supplier of research tools for the life science community, to widen their portfolio to include molecular-based detection kits through a strategic partnership. To build inroads into the clinical market, DNAS partnered and signed a distribution agreement with Horiba Medical (Canton, MI) to make its assays available to the Horiba team of 80 international distributors.

PCRassays has customers in Michigan that include Great Lakes Medical Laboratories (Farmington, MI), Biogenetics (Southfield, MI) and World Wide Labz (Detroit, MI), Henry Ford Health System (Detroit, MI) and Wayne State University (Detroit, MI).