NEW YORK – Traditionally a reagents and instrument supply firm, Takara Bio USA recently partnered with a clinical laboratory to develop high-throughput multiplex syndromic qPCR panels. The San Jose, California-based company now hopes to expand further into the clinical lab diagnostics space through additional partnerships with customers.
Developed and validated by Houston-based BioExcel Diagnostics, the laboratory-developed test panels use the Takara SmartChip qPCR System to detect viruses, bacteria, fungi, and antimicrobial resistance genes. BioExcel has validated multi-pathogen panels specific for urinary tract infections, respiratory tract pathogens, sexually transmitted infections, wound infections, nail fungus, antibiotic resistance, and women's health.
BioExcel Diagnostics is a full-service, CLIA-certified high complexity laboratory specializing in molecular diagnostics and clinical genomics.
Mehdi Dehghani started BioExcel in 2021, bringing 20 years of experience developing genomic testing workflows at his former employer Companion Dx Reference Lab as well as other firms.
The clinical lab space is "a tough business," he said in a recent interview, but he saw a need for a service provider that understands the details of molecular diagnostic testing.
"My vision was to start a lab to mitigate some of the inefficiencies that we see in molecular diagnostic testing, while still providing high quality results," Dehghani said.
As a new lab, BioExcel needed a system for molecular testing, and to his mind there were three or four commercial offerings that could perform high-throughput qPCR. However, "one of the challenges in the last three years has been the reduction in the lab fee schedule," Dehghani said. "Sometimes it is very difficult to get reimbursed for the testing menu, even for infectious disease."
Thus, BioExcel sought a system that could help better manage cost, which for Dehghani meant more control over the panel design. For reference and clinical labs, the number of samples varies day to day, so a modular, customizable format enabling change in pathogen targets is important.
"At the end of the day, you validate each assay; you don't validate the panel," he said.
The SmartChip can be customized by end users, and it also has a lower price point than similar systems, Dehghani said. The reaction size of 100 nanoliters may also enable increased sensitivity compared to competing technologies with reaction sizes of 33 nanoliters, for example.
"That means you can add more sample, and have more DNA in your reaction," he said, adding BioExcel has achieved a turnaround time of 24 to 48 hours using the Takara SmartChip system.
Overall, Dehghani said the quality and reproducibility of the panels is great, but added that "a test is not just a platform." The lab has established extensive quality controls to make sure it delivers high quality results, including layers of QC and process controls, as well as an added QC step at the end of testing reviewing results in the context of patient information before they are entered in the laboratory information system.
The BioExcel team plans to publish studies of its panels, but it currently is focused on commercialization.
Liz Quinn, VP of marketing at Takara Bio USA, said the firm is partnering with Dehghani in the panel development, and also hopes to assist other customers to run similar panels.
From a commercial side, Dehghani is also helping Takara Bio engage new customers to start running infectious disease panels, and potentially developing other panels in the future.
Historically, "Takara Bio has been an enzyme supplier into diagnostic labs," Quinn said. "Our new strategy is to develop more content — more panels, and more targeted assays in the clinical space — and then combine that with our instrumentation."
The SmartChip technology came to Takara in the US through the acquisition of Wafergen in 2017, and all of the developments in infectious disease and antimicrobial resistance is happening in the US and then sold globally, she said. Takara developed a high-throughput SARS-CoV-2 assay on its SmartChip system in 2020, but by the time the firm filed for Emergency Use Authorization, the US Food and Drug Administration had shifted focus to point-of-care testing over high-throughput.
Quinn said the firm did see a lot of traction supplying enzymes during periods of supply chain crises, however. This in turn had a positive impact on the business, acting as a catalyst to collaboration with customers, and helping establish the partnership with BioExcel Diagnostics.
The SmartChip system consists of three parts: a dispenser, a thermal cycler, and the chip itself.
Using a computer interface, the SmartChip can be laid out to run more assays on fewer patient samples, or more patient samples each run with fewer assays. "It gives you a lot of flexibility on how you use the real estate on that chip," Quinn said.
Specifically, the chips can be configured to run 14 different sample and assay configurations, with as few as 12 assays run on 384 samples, or as many as 384 assays run on 12 samples. This flexibility may differ from similar commercial technologies which are sold with assays pre-dispensed in chips.
"Especially in infectious disease, you might change your mind on one of the pathogens or assays you want to include," Quinn said, which can be tricky with a fixed chip.
"With our dispenser, you can make that decision in the morning," she said, which is helpful for clinical labs that have variable numbers of samples to run each day. "It gives them complete control over their testing," Quinn added.
Takara Bio also sells optimized enzymes and reagents for use on the instrument, but customers are in charge of the assay component of the testing.
The SmartChip instrument list price is approximately $200,000, Quinn said. Customers also need to purchase chips, source plates, and qPCR master mixes.
As an example, the reagents and consumables to run the UTI, STI, and wound infection panels in parallel cost approximately $800, she said, or approximately $10 per reaction. However, the pricing is also account-specific, and the list price doesn't always reflect the true selling price.
"We work closely with each customer to develop a pricing structure that works for their budget," Quinn said.
To date, the customers for the SmartChip system include academic core labs, diagnostic clinical testing labs, and pharmaceutical companies, Quinn noted.