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Codetta Biosciences Developing Highly Multiplexed, Multiomic PCR Platform

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BALTIMORE – With $15 million injected into its balance sheet from a Series A financing, Codetta Biosciences has received a boost in its mission to develop a digital spatial PCR (dsPCR) platform with multiplex and multiomic capabilities.

The startup claimed its anticipated platform integrates reagents, hardware, and software, and will enable "highly multiplexed, quantitative, simultaneous multiomic analyses" of DNA, RNA, and protein, though its technical details remain nebulous to the public at this time.

"We're not disclosing a lot of depth on the technology at this point in time," said Codetta CEO TJ Johnson. "Essentially, we run a chemistry that runs independent, spatially differentiated reactions in a microfluidic chip."

According to Johnson, Codetta started to operate last November, built upon a microfluidic technology invented by the Michael Ramsey lab at the University of North Carolina at Chapel Hill that was exclusively licensed to the company.

Johnson said Codetta aspires to solve two bottlenecks in the industry. For one, he said, currently in order to obtain multiomic data, labs often require multiple pieces of equipment and various workflows, which demand more samples and higher research costs. And he believes Codetta's integrated platform will help labs "consolidate their workflows" to achieve multiple analyses on the same platform.

Additionally, he believes there is an underserved mid-plex market that sits between next-generation sequencing and real-time or digital PCR platforms. Codetta's technology and platform will "fit in perfectly and very nicely" in that space, he said.

To that end, Johnson said Codetta's benchtop platform will especially differentiate from existing digital PCR platforms by its higher multiplexing capability — digital PCR technologies tend to cover fewer than 10 targets at once, but Codetta's platform is already designed to simultaneously target 30 DNA, RNA, and protein markers "in a seamless fashion" on the same specimen, with the possibility to continuously improve in the future.

"The issue that a lot of digital PCR instruments have is as you increase in plex, you decrease in sensitivity," said BJ Kerns, Codetta's chief marketing officer. But she said that won't be a concern for Codetta's instrument because it is "a highly parallel partitioned digital apparatus," and the system's spatial partitioning design can help avoid that problem.

Another pitfall for conventional digital PCR technology is false positivity, Kerns added. In contrast, she said Codetta's system offers both real-time PCR and digital PCR readouts. And the combination of real-time PCR's cycle threshold (Ct) values and digital PCR's endpoint data allows researchers to discern false positive or negative results, augmenting the data's accuracy.

One more advantage of Codetta's instrument that Kerns touted is that it can generate results in the same format across DNA, RNA, and protein readouts, eliminating the hurdle for researchers to assimilate various results generated from different workflows, such as nucleic acid assay, flow cytometry, immunoassay, and immunohistochemistry analysis.

While Codetta remains reticent about its technology, Kerns said the workflow involves both digital spatial PCR and digital spatial immuno PCR, which has "an immunoassay component to it." And according to Johnson, the platform's "specimen in, data out" workflow covers the upfront fluid reagent handling, the PCR reactions, as well as the optical capabilities to quantitate.

In terms of throughput and turnaround time, Johnson said the company currently aims to design the platform to achieve upwards of 40 samples per run with two to three hours of turnaround time. He said the platform will be compatible with liquid or FFPE specimens and extracted total nucleic acid.

For post-PCR analytics, Johnson said the company has also hired a team of software engineers to develop data analysis software that will be proprietary to Codetta as part of the integrated workflow. While users can define their own PCR targets, the company also plans to develop proprietary chip panels with preset markers, he added.

With the Series A funding, Johnson said the company will now predominantly focus on taking the technology out of the university lab and accelerating it into a commercially viable platform. To that initiative, he said the company plans to further expand to over 20 employees by the end of this year from the current 15. Meanwhile, Codetta is also in the process of settling into its R&D center in Durham, North Carolina, in addition to its headquarters in Morrisville.

Johnson said he is optimistic that the system will ​​"'move the needle" in translational research, and while it will initially be a research-only product, Codetta is eyeing the clinical diagnostic market in the long run. But he declined to provide a clear commercialization timeline or potential price tag for the instrument.

According to Johnson, the company currently has "a very active" key opinion leader program, through which Codetta has already engaged with potential customers, mostly translational researchers spanning academic labs and the biopharma industry. One "very key outcome" of this program, he said, is to generate studies and publications that can bolster the platform as the company gets close to the commercial launch.

"We think we have a great technology," Johnson said. "We want to rapidly put it into the appropriate form factor of a commercial instrument and get it on the market."

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