Bringing lab testing to the home

Six in 10 Americans are living with at least one chronic disease, and four in 10 Americans have two or more chronic diseases. Some of those diseases, such as hypothyroidism and inflammatory diseases, require individuals to carefully track certain blood tests in order to manage their conditions. Unfortunately, that usually means an onerous cycle of scheduling appointments, traveling to hospitals, and waiting for lab results.

Now SiPhox Health is working to help patients and their doctors manage diseases from the comfort of their home with a new kind of blood test based on a silicon photonic chip. The system is the size of a coffee maker and can produce precise readings for 20 different biomarkers.

The chip-based device is not yet FDA-cleared, so it is currently only being used for research purposes, but SiPhox also provides mail-in blood testing to thousands of people with chronic diseases, both directly and through other health care and wellness businesses, using approved technology. The company hopes its new system can soon deliver faster results to every home that needs it.

"A lot of blood tests aren't done because they're too inconvenient," SiPhox founder and former MIT researcher Michael Dubrovsky says. "People skip scheduled blood tests, and physicians don't always prescribe blood tests because they know it's inconvenient. That requires them to base their decisions on symptoms, and that's not optimal for many of these chronic diseases."

Dubrovsky and SiPhox co-founder Diedrik Vermeulen met at MIT while researching photonic chip and laser technology. They see SiPhox's technology as the latest in a long trend toward smaller and more scalable devices as they are condensed onto integrated chips.

"Biolabs typically do blood testing with these large instruments that are full of optics, lasers, lenses, mirrors, and all these very expensive features," Vermeulen says. "We don't change any of the main features. We leave all the optics the same, but we miniaturize it onto our chips and make it so scalable that you can ship it to homes. It's like how computers used to be the size of a room and you could only find them in high-end universities - now they're all on a chip. We're doing the same for blood testing."

Photonic chips with electric properties

Dubrovsky and Vermeulen met through the MIT ecosystem in 2019. Vermeulen had worked in MIT's Silicon Photonics Group within the Research Laboratory of Electronics and Dubrovsky was working in the MIT Materials for Micro and Nano Systems group.

The two quickly bonded over a new way to approach optical chips.

"We had this idea of doing optical chips more like a printed circuit board," Vermeulen explains. "Electrical chips incorporate a lot of chips on one circuit board, but optical chips typically do everything with a single chip. We wanted to combine optical chips into a new kind of circuit board."

The founders met regularly in the Martin Trust Center for MIT Entrepreneurship to refine their approach. In February of 2020, they started filing patents and receiving guidance from MIT professors. They also entered the START.nano program, which helps early-stage companies accelerate their innovations by giving them access to MIT.nano's laboratories and equipment.

The same lasers that are used to mass produce traditional silicon chips can be used to manufacture SiPhox's integrated photonic silicon chips. Each 1-millimeter chip contains lenses, polarizers, modulators, splitters, and other optical components you'd see in a traditional lab-based system, but SiPhox's chips are cheap enough to be single-use.

Just as the founders were deciding on the first application for their new chip, the Covid-19 pandemic hit. They took that as a sign.

"We decided to focus on biosensing, with one of our chips being disposable and the other one being reusable," Vermeulen says.

The founders worked to detect infectious disease with their chips but realized the technology was better suited for high-fidelity blood testing.

"I worked a lot on tunable lasers at MIT, and we use a slightly different approach to lasers at SiPhox," Vermeulen says. "We applied all of the lessons we learned at MIT to design something from scratch."

SiPhox's chip testing system works with third-party arm patches that people already use to collect blood samples at home. Dubrovsky likens the system to a Nespresso machine in which users simply place a pod into the machine and press a button. Each of SiPhox's disposable cartridges contains an array of photonic immunoassay sensors that can be used to detect specific proteins or hormones.

The system includes a dashboard that can be viewed by a physician or the patient themselves to get biomarker data at home. The dashboard also provides historic data and educational content about the biomarkers measured. SiPhox also uses large language models to parse third-party blood test data, allowing users to track traditional blood tests in the same dashboard.

Because the approach makes use of semiconductor lasers and silicon chips, the founders say a single traditional chip manufacturing facility, or fab, could produce 1 billion of SiPhox's chips every month.

"Our technology is very scalable because it's all on a chip," Vermeulen says. "There are only two ways to really scale something: You can do injection molding; that's how you produce billions of plastic cups, for instance. But if you want to scale something very complex, you have to put it on a silicon chip."

A platform for health

The founders believe their technology could enable a world where tracking biomarkers is as easy as brushing your teeth. That would have huge implications for the tens of millions of Americans who need to get regular blood tests to manage chronic diseases.

"For people with inflammatory diseases, tracking inflammation levels is very important because they can develop resistance to their medicine," Dubrovsky says. "Once they experience symptoms of a flare-up, it's very hard to reverse. And these symptoms can be horrible, so catching it early is really important."

To gain FDA clearance, SiPhox plans to begin studies in coming months, but its system's accuracy has already been validated by third parties, and the company's Burlington, Massachusetts, facility is capable of manufacturing about 10,000 of its cartridges per month.

Once SiPhox gains FDA clearance, it plans to partner with health care systems, health insurers, employers, and mail-in blood testing companies to help people everywhere track their health.

"We can offer a new way for people to access health care in their home," Vermeulen says. "Once they have our blood testing device, whether for a chronic disease or something else, anytime they want telehealth-enabled by blood testing, they can use our device, similar to how Apple users have access to third-party apps from many different service providers. Siphox users will have access to curated third-party services built on top of the core blood testing capability."

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