NEW YORK – When OraSure Technologies announced a $30 million investment and exclusive distribution contract with Sapphiros last week, it was a sign of a financial turnaround for the nearly 40-year-old Bethlehem, Pennsylvania-based diagnostics developer. After emerging from a period of strategic review and restructuring, the deal is part of the new CEO's broader strategy to build on OraSure's strengths, including in manufacturing and distribution.
OraSure's investment also affords it a minority ownership position and a seat on Sapphiros' board of directors, CEO Carrie Eglinton Manner said on a conference call held last week to discuss the deal, adding that the multiyear exclusive distribution agreement for Sapphiros' new products begins when the products launch.
The deal is ultimately expected to allow OraSure to offer a more comprehensive range of low-cost tests and sample management solutions. The first product launched will likely be a self-collected blood sampling device for molecular testing, Manner said on the call, followed by visual and digital lateral flow tests for infectious diseases and a molecular diagnostics platform.
After incremental SG&A expenses over the next two years, OraSure expects to leverage its existing infrastructure, capabilities, and customer relationships so that Sapphiros' products will be accretive to its operating profile in 2026.
In a follow-up interview, Manner noted that the OraSure and Sapphiros teams are well aligned both in terms of purpose and portfolio.
Both firms aim to meet a global need for high quality, affordable, and accessible diagnostic assays, she said, and both have developed novel technologies that encompass sample collection and testing.
The firms' areas of expertise are also complementary. OraSure specializes in saliva-based sample collection for genomic testing as well as over-the-counter infectious disease diagnostics. Sapphiros, meanwhile, has expertise in self-collected blood sample collection and has developed low-cost, instrument-free, at-home, and point-of-care diagnostic platforms that can be manufactured in a scalable way at high capacities, Manner said.
"These low-cost, high-volume platform technologies have the potential to increase access to segments that are harder to reach," she added.
Sapphiros is a private growth equity firm that was founded by Namal Nawana with support from investment firm KKR and Neoenta, a design and investment firm focused on medical devices and diagnostics. Nawana previously served as CEO of Alere before that firm was acquired by Abbott for $5.8 billion. He was then CEO of UK medical equipment firm Smith & Nephew until stepping down in 2019.
As a partnership between KKR and Neoenta, Sapphiros consists of a portfolio of consumer diagnostic technologies, according to Mark Gladwell, president and CEO of Sapphiros who also served with Nawana at both Alere and Smith & Nephew.
Sapphiros was originally created in 2021 via an undisclosed stake in GrapheneDx, a diagnostics company also founded by Nawana, combined with the acquisition of Biocrucible, a molecular diagnostics firm founded by Niall Armes, the cofounder of TwistDx and a co-inventor of recombinase polymerase amplification.
Sapphiros subsequently acquired Flexotronix, a developer of high-speed reel-to-reel manufacturing lines for printed electronics using conductive inks and proprietary lateral flow formats.
Development of Flexotronix's Extreme Volume Manufacturing process for diagnostics was funded in part by approximately $5 million from the Bill & Melinda Gates Foundation. In a press release to announce the acquisition of Flexotronix in 2022, Sapphiros said the manufacturing line has a measured capacity of up to 5 billion tests per year.
Sapphiros also made an investment in Satio, a maker of blood collection and vaccine delivery patches, and has a direct-to-consumer sales organization, called GoToKnow, distributing wellness genomic tests and COVID-19 rapid antigen assays branded iHealth.
In 2023, Sapphiros was awarded $11.1 million from the US National Institutes of Health's Rapid Acceleration of Diagnostics, or RADx, program to develop an over-the-counter multiplex assay for the rapid detection of respiratory syncytial virus, influenza A and B, and COVID-19. Its Biocrucible division was granted $1.0 million over eight months by the Gates Foundation for the development of a "ultra low-cost" field and consumer molecular diagnostic platform with its proprietary isothermal nucleic acid amplification technology.
With the new partnership, "OraSure provides us the opportunity to leverage their strong customer relationships and commercial capabilities," Gladwell said. OraSure in turn will have access to Sapphiros' patch devices, and diagnostics encompassing visual and digital lateral flow, biosensors, and molecular technologies, he added.
Going forward, Manner said the partnership also stipulates an opportunity for co-funding and codevelopment of additional products and access to Sapphiros' "exciting" pipeline of next-generation technology platforms.
Fall and rise
From previous executive positions at Quest Diagnostics and GE Healthcare, she was charged with leading OraSure out of a bit of a tailspin. The firm parted ways with its former CEO, Stephen Tang, and entered the strategic review process in January 2022, due in part to troubles related to manufacturing scale-up for its COVID-19 assay and global supply chain challenges.
"The business had become unprofitable through investing to serve the COVID pandemic," Manner said. "What we really had to do was rebalance the cost structure of the organization, apply Lean Six Sigma process improvements, and take out a lot of product cost in order to get to a place where we could deliver efficiencies and rebuild our cash balance," she added.
In February 2023, OraSure disclosed that it had restructured to merge its diagnostics and molecular business units, a move that led to layoffs of 11 percent of its workforce but is projected to save the firm $15 million per year over the first two years.
The firm then moved forward by focusing on building on its strengths, Manner said.
For example, during the pandemic OraSure developed a new testing technology, branded InteliSwab, with a sample collection element connected to a lateral flow test to enable a simpler consumer experience.
"There's no counting droplets; it is just swab and swirl," Manner said.
It's InteliSwab COVID-19 test was granted Emergency Use Authorization by the US Food and Drug Administration for use on adults as well as children as young as 2 years old. It was selected for mass distribution in US schools in 2022 as part of a $205.2 million procurement contract with the US Defense Logistics Agency.
Through funding OraSure received to ramp up manufacturing of COVID-19 testing — specifically $109 million from the US Department of Defense and approximately $5.7 million from the US Department of Health and Human Services — it was able to expand its local manufacturing and close its overseas production operation as part of a broader strategy to consolidate manufacturing, Manner said.
OraSure in late 2022 opened a brand new 139,000-square-foot manufacturing facility with the capacity to manufacture approximately 2 million COVID-19 tests per week through highly automated manufacturing processes.
"We eliminated significant product costs by improving the yield of our manufacturing," Manner said. The company also designed more efficient packaging for the InteliSwab, eliminating costs on the materials as well as freight and shipping.
By implementing all of these strategies, "we've turned the business around toward profitable growth and more than doubled our cash balance in less than a year," she said, citing OraSure's first quarter 2023 revenues.
After strengthening the foundation and elevating core growth, the third step in Manner's plan is to accelerate profitable growth.
This includes plans to both "advance our internal innovation roadmap and to invest in external partnerships to expand our portfolio of diagnostic tests and sample management solutions," she said, with the Sapphiros investment being an example of the latter.
OraSure has also seen steady core growth in the past year or so.
This was supported in part by the adoption of the firm's non-COVID testing portfolio, for example, through selection to be the test provider for a Centers for Disease Control and Prevention HIV self-testing program called "Together Take Me Home."
The federal contract supports supplying up to 1 million OraQuick In-Home HIV Tests over five years to be delivered to at-risk people by mail.
OraSure obtained FDA clearance for over-the-counter, direct-to-consumer use of its OraQuick saliva collection device in late 2022 through its partnership with Grifols to support screening for alpha1-antitrypsin deficiency. Grifols began offering a free AlphaID At Home Genetic Health Risk Service to support alpha-1 screening using the device to help identify individuals at risk for alpha 1-related lung disorders.
OraSure also recently signed a multiyear collaboration contract with the Regeneron Genetics Center, a wholly owned subsidiary of Regeneron Pharmaceuticals, that will leverage OraSure's in-house kitting and single-order fulfillment services to remodel RGC's DNA collection workflow and supply OraGeneDx saliva collection devices for its early gene discovery and functional genomics work.
The firm was awarded an $8.6 million contract from HHS's Biomedical Advanced Research and Development Authority to develop a second generation of its de novo authorized rapid test for the Ebola virus.
And OraSure subsidiary Novosanis' self-sampling device for urine sample collection, called Colli-Pee, was used in a recent UK study of human papillomavirus detection for cervical cancer screening. Published in BMJ Open, the economics study found that self-collected urine samples were more cost-effective than self-collected or clinician-collected vaginal samples for HPV-based screening and could improve patient access.
Overall, "I'm really proud of what the team did to serve in a crisis, but also fundamentally then reset and move forward with stronger muscles that we built during the process," Manner said.