NEW YORK – Singapore-based Credo Diagnostics Biomedical is preparing to start US clinical trials for a new near-patient point-of-care molecular diagnostic system and multiplex respiratory test. The company intends to submit the instrument and assay to the US Food and Drug Administration for 510(k) clearance and to use it as a springboard for entering the US diagnostic testing market.
Called the VitaSIRO Solo — with SIRO short for "sample-in, results-out" — the new system was developed with the intention of bringing lab-quality testing to the point of care, according to Tan Tai Lim, the firm's vice president.
Credo expects to begin clinical trials at 15 US sites in November for an assay to detect SARS-CoV-2, influenza A and B, and respiratory syncytial virus. Lim said the company's predicate device is Cepheid's Xpert Xpress CoV-2/Flu/RSV plus assay, adding that it has achieved 98.2 positive percent agreement and 100 negative percent agreement with this assay.
The firm already markets a near-patient system called VitaPCR that has a 20-minute turnaround time that Lim said generated "explosive revenue" during the Covid-19 pandemic. "Like our peers, respiratory testing is now seasonal," he said, with seasons alternating between the Northern and Southern Hemisphere.
But unlike the VitaSIRO Solo, the VitaPCR system performs direct PCR and does not have on-board sample extraction, Lim said. It was adopted for COVID testing globally during the pandemic, but its use is limited to respiratory swab samples, he added.
Realizing that "POC is the future," Lim said, Credo decided to go back to the drawing board and develop another platform.
Like others in the POC space, Credo established that connectivity and ease of use are among the most critical requirements for end users in all settings. The VitaSIRO system was therefore designed to integrate seamlessly with electronic health records, Lim said, including having an ethernet port for local area network connectivity as well as using POCT-1A device communication.
The system is small — weighing less than a gallon of milk, with the footprint the size of a standard sheet of printer paper — and has a built-in seven-inch interactive LCD screen. It was also built to help lab customers meet ISO 15189 standards for quality control and risk management, Lim said.
The assays come in self-contained, all-in-one reagent cartridges that use microfluidic technology. Turnaround time is 40 to 45 minutes, Lim said, and the system can process other types of specimens besides respiratory samples, such as blood and urine.
Credo expects to offer the VitaSIRO Solo system for $6,000 and each assay for $20, Lim said.
The firm is able to keep the cost of the system low because it builds approximately 90 percent of the VitaSIRO instruments and cartridges in-house at its manufacturing facility in Taiwan. "We will translate these cost savings to patients and to end users … but importantly, without compromising performance," he said.
The VitaSIRO system has seven optical channels, so it can detect six targets and one control. This could be expanded to up to 18 targets and three internal controls to enable syndromic testing. It also reports Ct values.
Furthermore, "we wanted a maintenance-free platform," Lim said, so the VitaSIRO Solo does not require any calibration, pre-analytical sample steps, or maintenance, with ease of results interpretation.
Credo has 135 employees and is headquartered in Singapore, with a branch in Taiwan, Lim said.
The company sells its systems and assays in more than 50 countries, primarily through distribution partnerships. Its end users include laboratories, clinics, and hospitals, and are deployed in emergency rooms and operating rooms. Within this near-patient molecular testing space, it will potentially face competition from established systems like the Cepheid GeneXpert, as well as newer ones like the QuidelOrtho Savanna, SD Biosensor Standard M10, or Becton Dickinson Elience.
Credo is growing its list of distributors by exhibiting at major conferences like the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) and Association for Diagnostics & Laboratory Medicine (ADLM) meetings, as well as through direct marketing and referrals from existing distributors, Lim said, adding that the firm also has some distributors that came directly to the company.
The VitaPCR platform and respiratory assay line are all CE-marked, Lim said, and the firm recently received the CE mark for the VitaSIRO Solo platform and the VitaSIRO Solo SARS-CoV-2/Influenza/RSV assay.
While Credo is not yet selling in the US, it hopes to kick off commercialization after obtaining 510(k) clearance for the VitaSIRO platform and multiplex respiratory assay and plans to work with distributors.
Credo is also still learning about reimbursement in the US, Lim said, in part through its membership in the MedTech Innovator Program.
Future tests for the VitaSIRO Solo include an HPV assay, scheduled for the second half of next year; a four-target sexually transmitted infections panel to detect Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and Mycoplasma genitalium in 2027; a gastrointestinal panel in 2028; and a Troponin I test at a future date.
The firm also intends to increase its activities in the animal health and veterinary medicine space globally, Lim said.
Credo is privately held, and its operations were first funded by its shareholders and subsequently with revenues. "We are now considering inviting cornerstone investors as part of our grand plan to seek a listing on the Nasdaq in 2027/2028," Lim said.