NEW YORK – Diagnostics for the Real World, colloquially referred to as DRW, spun out of the University of Cambridge more than 20 years ago. But in many ways, the molecular diagnostics firm resembles a newly minted startup as it prepares for the imminent launch of a retooled version of its rapid, multiplexed, point-of-care molecular diagnostics platform and six new test panels.
The company, which is headquartered in Little Chesterford, UK, with a location in Morgan Hill, California, will also target new markets as it seeks UK and European regulatory compliance while remaining true to its tagline: "Balancing doing well with doing good."
For the first 15 years or so of its existence, DRW focused primarily on developing molecular diagnostic tests for the developing world. The company had moderate success, placing its early SAMBA (simple amplification-based assay) systems and various tests — based on isothermal nucleic acid amplification — in several African countries.
Then, in late 2019, everything changed with the COVID-19 pandemic. Like so many others, the company quickly pivoted to develop COVID tests, and its inexpensive and easy-to-use technology had some success, garnering a CE-IVD mark for a SARS-CoV-2 assay in 2020 and subsequently winning a sizable contract for the assay from the UK government.
DRW was able to parlay that success into new investments and a somewhat new direction, technologically speaking, CEO Helen Lee said earlier this week at the European Society of Clinical Microbiology and Infectious Diseases global congress in Vienna, where the company organized a symposium and had a booth in the exhibit hall.
Whereas previous SAMBA platforms used an isothermal amplification technology, the forthcoming SAMBA III will now be based on rapid qPCR, which is generally more accurate and robust than isothermal amplification but usually with the trade-off of higher costs.
The COVID pandemic was transformative for the company and taught it plenty of new ways to approach molecular testing. "We were doing things in impossible situations, dealing with supply chain issues," Lee said. "It was baptism by fire."
Now, with SAMBA III, Lee said, the company has achieved rapid qPCR through the careful optimization of every aspect of the process, or, as Lee put it, "a more holistic approach."
SAMBA III is a quantitative real-time PCR platform that can detect up to 18 targets divided among three amplification "cartridges" that are seated in a rotor contained within an otherwise starkly plain-looking benchtop module about the size of a Nespresso machine. In the only truly hands-on step, a user places a patient sample — usually a swab — into a large external plastic prep tube filled with liquid, then uses a disposable plastic pipette to dispense the prep tube liquid into three smaller tubes on the cartridges. After scanning some barcodes, the user then places the cartridges in the instrument.
An app running on an external tablet controls up to eight separate platforms, and all extraction, sample prep, and thermal cycling occurs automatically on the system. The app reports a yes/no answer but can also provide Ct values for those who find that information useful. Finally, each machine can be used as standalone or can be integrated into a LIMS, and an optional middle step called the DRW Hub provides a mini-informatics system through which users can view and analyze all results coming off of the machines controlled by a particular app.
The turnaround time for results varies depending on the type of panel, but in general, the company claims it is between 35 and 50 minutes.
SAMBA III will launch with six test panels, including a test to detect and distinguish between two major SARS-CoV-2 variants; a SARS-CoV-2/influenza A-B/respiratory syncytial virus panel; and an extended respiratory panel with eight different targets. The launch menu will also include a panel for sexually transmitted infections associated with skin ulcers, including mpox (STI ulcer panel); a test to distinguish between mpox clades I and II (Mpox I/II); and a test for common STIs and antibiotic resistance using discharge samples (STI discharge panel).
The company also has a gastrointestinal panel and malaria panel in research and development.
DRW will target the UK market first and has already submitted SAMBA III for UKCA marking. It also very recently submitted the platform for CE-IVDR registration, which would allow the firm to market it throughout the EU and other territories recognizing the CE-IVDR mark. It expects this registration by June, Lee said. The various test panels are also all on track for either UKCA or CE-IVDR registration this year.
Lee also noted that the company has self-funded SAMBA III's entire development and still has a cash runway of 2.5 to three years at its current spend rate. As such, it is not currently seeking additional funding, but it is looking for "a good commercial partner since sales and marketing are the aspects we are lacking."
The company has not finalized pricing yet, and Lee declined to provide a ballpark figure, instead noting that "since the design and manufacturing of SAMBA III cartridges are much simpler than many of the microfluidic-based cartridges, we expect that at equal volume, the SAMBA III highly extended multiplex cartridges will be significantly cheaper." She also said that the company will "definitely" use two-tier pricing, selling the tests at a greatly reduced price in resource-limited settings.
Early data
At the ESCMID symposium, Sonny Assennato, DRW's director of R&D, shared early top-line data from the SAMBA III STI ulcer, Mpox I/II, and STI discharge panels.
The STI ulcer panel tests for mpox alongside four other STI targets likely to cause skin ulcers (herpes simplex viruses I and II, Treponema pallidum, and Lymphogranuloma venereum) and can be run in one cartridge on the SAMBA III with a second cartridge containing the Mpox I/II test to determine the specific clade.
DRW retrospectively tested the SAMBA III Mpox I/II assay on 25 mpox clade I specimens (all positive) from Uganda and Gabon and found 100 positive percent agreement (PPA) compared to molecular tests from the US Centers for Disease Control and Prevention and BioMérieux, with Illumina sequencing performed to confirm the clade. They also ran the assay on 136 specimens (31 positive) from Denmark and found 100 percent PPA and negative percent agreement (NPA) when compared to Qiagen's QiaStat-Dx Viral Vesicular Panel.
Company scientists also tested the SAMBA III ulcer panel on 184 specimens from Africa and Denmark and found that it had 100 percent PPA and NPA for the three types of infections found: mpox I/II, HSV-1, and HSV-2.
"When I was in Gabon, they provided a sample to me, and in under an hour we got positivity for mpox but also the clade … and they couldn't believe that," Assennato said at the symposium, further noting that the status quo in Gabon has been to send samples collected from anywhere to the capital Libreville to test for mpox positivity, then the samples are sent to a different location in the country to determine the clade, resulting in a turnaround time of a few days at best.
At the symposium, Isaac Ssewanyana, director of laboratory services at the Uganda National Health Laboratory Services, discussed the ongoing mpox outbreak in his country and other African nations, noting that on Aug. 13, 2024, the Africa CDC declared the outbreak a Public Health Emergency of Continental Security (PHECS), about two years after the World Health Organization declared it an emergency on the continent.
"The current mpox situation in Uganda as of March 2025 [is that] clearly the virus is gaining transmission and the routes of transmission are expanding," Ssewanyana said. "There are challenges in surveillance in the ongoing response — it’s not easy to predict where we will see the next outbreaks. Centralized testing especially makes it difficult, as it has a long turnaround time and fragmented data collection tools and systems. This is where the SAMBA comes in. We need SAMBA III yesterday."
DRW recently submitted the Mpox I/II test to the World Health Organization for Emergency Use Listing and is awaiting a determination.
Assennato also presented data for the SAMBA III discharge panel, which tests for Chlamydia trachomatis, Neisseria gonorrhoeae and NG quinolone resistance, Trichomonas vaginalis, and Mycoplasma genitalium and MG macrolide resistance.
For this prospective study, they tested 243 samples, a large proportion from sex workers, at a clinic in Iloilo City, Philippines, collecting vaginal swabs from women and urethral swabs from men. Of the 243 samples, 112 were positive for some kind of infection with 41 coinfections.
They compared the results of the SAMBA III panel with Roche Cobas CT/NG and TV/MG tests, an EliTech InGenius MG macrolide resistance assay, and a sequencing-based NG quinolone-resistance assay from Eurofins Genomics and found that the SAMBA PPAs ranged about 96.6 percent to 98.5 percent with 100 percent NPA across the board.
John White, a UK National Health Service consultant physician and executive medical director at Preventx, a UK provider of online self-sampling services for STI/HIV testing, said in an email that the SAMBA III is a "really exciting development" that offers a "new paradigm in the way that we manage symptomatic patients within clinical sexual health services."
"Previously, we have relied on centralized laboratories to give us diagnostic test results using extremely sensitive and specific molecular tests, but results usually took days or even weeks to come back," said White, who also has been a part-time clinical consultant for DRW since 2006.
"SAMBA III offers us the potential for diagnostic test results that are more accurate and also available while the patient is still in the clinic," he added. "This will allow us to inform our patients of their diagnosis, and for some STIs, it also allows us to choose the right drug and commence this treatment straightaway. This means that they also can inform relevant sexual partners of their diagnosis so that they too can get prompt and specific treatment, and this should help interrupt chains of transmission."
White noted that he has not used previous iterations of the SAMBA platform in his clinical work since they were optimized primarily for use in resource-poor settings. However, "the technology DRW has developed can also now benefit people working in any setting, and I'm keen to get my hands on SAMBA III," he said.