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Truvian Sciences Looks to Disrupt Dx Market With Three-Modality Platform

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NEW YORK – Theranos sounded too good to be true – and it was. Truvian Sciences has heard the comparisons to Elizabeth Holmes' company and wants you to know it's different.

Despite having another blood sample-based platform making bold promises, combining three different technologies to deliver point-of-care diagnostics in the retail clinic setting, CEO Jeff Hawkins was careful to emphasize that Truvian won't be taking any shortcuts in verifying its claims. 

"We will go the way of diagnostic platforms," Hawkins said. "We will take it through the regulatory path and undergo that scrutiny."

Truvian's as-yet-unnamed system is an automated benchtop system which the company claims can deliver lab-accurate results on par with Roche's cobas system when performing the three core parts of blood diagnostic testing: clinical chemistry, immunoassays, and hematology. 

The system uses "tried-and-true" technologies found in larger-scale diagnostic platforms and combines them with some of its own inventions within the platform. "When it comes to the technology and the science, our approach first has always been don't invent if you don't need to," Hawkins said. "You can get yourself into trouble by always trying to customize something or make something unique when it's not needed."

For example, in the clinical chemistry section, Truvian uses traditional absorbance technology to read those analytes, as well as similar chemistries and reagents that have been used for decades. It's currently using spectroscopy to do clinical chemistry, Hawkins said. It also, however, has developed a way to create a monolayer of cells for a complete blood cell count without using continuous flow or a Coulter counter, Hawkins said.  

The company wants to cover all the tests doctors order at a routine annual wellness exam, Hawkins said, including a comprehensive metabolic profile, a lipid panel, a thyroid stimulating hormone panel, and a complete blood cell count. Though there may be room eventually to expand the system's offerings to fertility or specific women's or men's health panels, Hawkins noted, right now the routine wellness visit tests are the main priority. Hawkins did mention the company is considering additional analytes such as vitamins D and B12, and folate.

"We think focus is key to staying on timeline and to continuing to execute in the way we have," Hawkins said. "We have not allowed ourselves to stray yet and expand the next set of work behind the scenes." 

Truvian has high hopes for the future of the system, and it recently announced a $27.1 million Series B financing round, which will help support its plans for a regulatory submission in the US next year. 

The company has already been in talks with the US Food and Drug Administration and is working to complete the clinical studies required for 510(k) clearance and a CLIA-waiver, with the goal of making its regulatory submissions by the end of 2020. It also hopes to obtain a CE-IVD mark once the FDA submission is made and begin commercializing right away. New Chief Commercial Officer Katherine Atkinson is working on defining the rest of the countries in which Truvian may want to commercialize the platform, Hawkins said. 

Currently, the company has no price point for the platform, but Hawkins said there's "substantial room" to reduce the prices of these tests in the market. He noted that the lower prices for comprehensive panels of 35 to 40 analytes are $300 to $400, with higher-priced tests topping out above $1,000.

"Making it more affordable is absolutely a big driver for us," Hawkins said. "It will be a significant shift from what insurance companies are paying for this test every day and in the market." 

The goal is to get the technology into retail, corporate, and private clinics with the potential to expand to primary care settings eventually. If that expansion does occur, Hawkins said, it will be in partnership with someone who has an appropriate commercial channel. 

The system will also launch with the capability to return results on patients' smartphones within 20 minutes of testing, said Kim Kamdar, co-founder of Truvian and the chair of the board of directors.

In-house, the company is currently running its second-generation alpha systems, which are fully integrated and running with plastic molded consumables. In the first quarter of next year, the company expects to have its beta systems ready with all the final changes Truvian wants to make. Those are the systems that will be used to complete development and run future studies in preparation for regulatory submission, Hawkins said. Final integration testing is also coming in the first part of next year.  

The company doesn't yet have external data, only the internal measurements it has shared with investors and which it refused to disclose. But, Hawkins said the company is comparing its clinical chemistry and immunoassay technology with Roche's cobas system, and comparing its hematology technology to Sysmex. 

"We're not doing internal comparisons against one-off platforms, or even other point-of-care platforms," Hawkins said. "We're making sure we hold ourselves to that higher standard of performance and test quality of those larger machines."