Diagnostics launches a $30 test that aims to tell if your liver is working

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If you are in a hurry In the hospital and for emergency surgery, it is helpful if the anesthesiology team can predict whether your body will react as they expect. In most cases, things go pretty smoothly, but if a patient has liver failure, things can get hairy quickly. Eventually, the diagnostics hope to solve this problem, although there are some regulatory hurdles to overcome before the device shows up in an ambulance near you. For now, the company is focusing on the veterinary market and announcing that it is starting to ship its products to the first wave of customers.

Pitching at TechCrunch Disrupt Battlefield 20 today, founding team Octavian Florescu (CEO) and Ana Florescu (COO) spent the last five years building and refining the tech at the heart of the device.

Citrus Heights Pet Hospital Dr. Avery Brickson, along with Booker, officially diagnosed with the first patient. Under her care, Booker is treated for Valley Fever and monitored bi-weekly from home with InD’s equipment. Image credit: in diagnostics

The company has developed a blood-testing platform that takes a drop of blood and displays diagnostic measurements on a phone or computer. At its core is a custom microchip containing a high-precision spectrophotometer (basically, a little camera) that can analyze blood. The first product is called the Quic ALT+AST test – a glucometer-like test that provides ALT and AST liver enzymes from a drop of blood in 5 minutes.

“Right now in emergency departments, they have an i-STAT, which measures things like electrolytes, blood gases, and they have kidney function, but they’re missing the liver. So that was the whole point of using the gap between other tools,” says Octavian. “We can just work with them and get your liver function for imaging, anything with anesthesia, anything with heavy-duty drugs that you need to treat right away. It gives you a quick, quick clue. “

The journey from genesis to launch of this product has been cyclical, starting with a doctoral thesis at UC Berkeley that was created at a company called Xip. Before being acquired by another company, the company was developing drop-of-blood immunoassay tests to detect heart attacks in patients with chest pain. Another company decided not to do anything with it, so the Florescus were able to buy back the IP for pennies on the dollar and continue building the company.

Diagnostics’ Quick Test in Action. Image credit: In Diagnostics.

The company’s first product is a liver enzyme test aimed at the veterinary and research markets — and enables home consumers to test their pets’ liver health.

“This is particularly useful in the research market for laboratory animals. So if you have a clinical trial, where you’re working with mice, you have a challenge: mice have small bodies, so they have very little blood to begin with. “It’s very important for them to note how the liver is doing. It’s especially important if they’re doing any toxicology-related studies,” explains Anna.

Instead of taking the always-publicly unsuccessful Theranos approach of testing everything on a very small blood sample, In Diagnostics is using similarly small sample sizes. A standard pipette drop is about 50 microliters. The diagnostics system needs only 25 microliters — half a drop of blood — to run its tests.

Within five minutes, the team showed the product in action, explaining how its device returned measurements of 67 and 151 for ALT and AST, respectively. Fully calibrated lab results running on the same blood were 70 and 165 — both numbers are within 10% of each other, but lab machines can’t compete with price, portability, convenience, and speed. The team conducted a correlational study at UC Davis, where they observed correlations of .98 and .92 for the respective measurements over a period of 60 measurements.

So that’s all well and good, but why does it matter? Well, it turns out that livers are pretty good up to a point, and beyond that point, things go downhill fast.

Octavian and Ana Florescu at their booth at the Packet Trade Show. Image credit: in diagnostics

“ASD and ALD enzymes are usually concentrated in the liver tissue, in two separate areas of the liver. If you have them in high values ​​in the bloodstream, it means that one or the other part of the liver is damaged and struggling. This is a sign of liver stress. And when it’s certain When it reaches values, it’s a sign of acute liver failure,” explains Octavian. “It’s an enzyme that shouldn’t normally be in the blood. And if it turns up in the blood, something’s wrong.”

The bottom line, the team tells me, is that the liver can reduce efficiency by up to 80% without any sign of a problem: you feel perfectly fine. Then you can go from only 20% liver function to acute liver failure in a very short period of time. Being able to monitor liver function over time can help inform how the liver is doing and take corrective action.

The company raised a $3 million Series A back in 2019 and is not yet sure if the growth path will lead them to additional VC funding or if they will continue with a leaner team and increased cash flow.

“We’re on the fence about whether to take the money and expand the menu and grow faster that way,” explains Octavian. “Menu,” in this case, is the number of tests the company offers to use with its device. “Our plan B is to just keep going, turn a profit and use the free cash flow to continue expanding the menu and market.”

With its current setup, the company says it can produce 400 test chips per day at a retail price of about $30 per chip. A dongle that plugs into a computer or smartphone is included in the free box with the clinic’s first order. The company plans to increase production significantly and consequently achieve better economics of the unit.

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