Truvian Sciences is developing an automated benchtop broad panel testing system on a “small sample of blood” to support which the company just raised $27.1 million.
How small? Seven drops to be precise. That’s six more than Theranos, which had an ignominious fall once the tall tales of its CEO caught up with the reality of how hard the science was
That comparison with the now-defunct Theranos is something that the chief execute of San Diego-based Truvian Sciences is more than prepared to counter.
In response to email questions surrounding its Series B funding forwarded by a spokeswoman, Jeff Hawkins, president and CEO lays out several differences including the “scrutiny” of the regulatory world.
“We are working toward a CE Mark in the European Economic Area and a submission to FDA for a 510(k) clearance along with a CLIA waiver application that will allow for use at a doctor’s office or retail setting,” he said. “We are on track to submit to FDA in the second half of 2020. Theranos operated under insufficient regulatory oversight, as we have all since learned in the media coverage of the fallout.”
In addition to performing a broad wellness panel on just 7 drops of blood compared to traditional lab testing that requires two to three vials through a venous blood draw, Truvian Sciences is also acknowledging the value of those tests that do require larger blood samples.
“Our platform is designed for flexibility allowing medical personnel the option for capillary sampling (finger stick) or venous blood sampling for a more comprehensive view of a patient’s health,” Hawkins explained of the system.
The product is designed to deliver results in 20 minutes compared with those that need to be sent to Quest Diagnostics or Labcorp for off-site lab analysis. The automated benchtop system that Truvian is developing combines chemistries, immunoassays and hematology assays in a single device for use in retail or clinics. Hawkins declared that “no single on-site diagnostic platform, until now, covers those three modalities while providing accuracy that rivals off-site labs.”
It’s not just the speed. If the system works, there’s a ton of cost savings to the system. Hawkins put it like this:
To give you an idea, currently for a consumer to get 40 of the most commonly ordered diagnostic tests the out-of-pocket costs are can be $250 or more. And, insurance companies often pay a higher cost at $500-1,000 for such tests. Our long-term goal is to drive the cost to less than $1 per analyte (i.e. $40 or less for the 40 analyte panel).
That potential for lower costs has impressed venture capitalists who pumped $46.3 million into Truvian to date, including the $27.1 million raised in the Series B round announced Wednesday. That investment was led by GreatPoint Ventures and included DNS Capital and Tao Capital Partners. Existing investor Domain Associates also participated in this round and Kim Kamdar, partner with the venture capital firm and chair of Truvian’s board also happens to be the diagnostic startup’s co-founder and previous CEO.
In a news release, Kamdar hailed the experienced industry executives that have joined Truvian. On Wednesday, in addition to announcing the fundraise, the diagnostics company named Katherine Atkinson as chief commercial officer and Paul Meister a board member. Atkinson held the same title at Epic Sciences and Meister was CEO of inVentiv Health and board chairman at Thermo Fisher Scientific. Hawkins comes from Illumina where he was vice president and general manager of reproductive and genetic health.
“The Board is especially encouraged by the support Truvian has received from the investment community and are pleased by the caliber of industry veterans who have joined the company,” Kamdar said in a statement.
While Truvian has been able to attract these executives, they will have to contend with competitors both in its backyard and halfway across the globe. Genalyte, based in San Diego, has raised $91.8 million per Crunchbase — more than Truvian — and has investors like Khosla Ventures and Redmile Group. Genalyte also appears to be ahead in its regulatory pathway – the company’s website notes that the FDA is currently reviewing its technology and the diagnostic device is named Merlin.
And then there is Sight Diagnostics, based in Israel, which has developed the Olo device which digitizes blood samples and then returns results using machine learning algorithms within minutes.
So, while Theranos is history, the traditional lab players like Quest Diagnostics and LabCorp shouldn’t rest easy with the likes of Truvian, Genalyte, Sight Diagnostics and others taking them on with fingerstick blood testing available at the point of care.
Photo: Truvian Sciences