Diagnostics · Consumer blood testing
SiPhox Health
An MIT spinout building a silicon photonic chip meant to run immunoassays in a countertop box at home. Until that chip clears the FDA, it sells mail-in blood panels collected from the arm and run by somebody else’s laboratory.
The box on the counter
A Boston Globe reporter visited Burlington in early 2025 and came away with a comparison the company has not shaken since. The device looks like a Mr. Coffee machine. You feed it a few drops of blood in a plastic cartridge, a pump pushes reagents over a chip the size of two grains of rice, and a laser reads each sensor in turn.
“It’s like a chemistry lab in there,” co-founder Michael Dubrovsky told the Globe.
The chips shown that day carried fourteen sensors. The version headed for the FDA is to carry forty-five tests, in a cartridge costing $50 to $75, with results in about an hour. None of it is on sale. It is the reason the company exists, and it is still ahead of it.
What SiPhox actually sells
What you can buy today is a mail-in kit. A device the company calls EasyDraw takes a small sample from the outside of the upper arm rather than a fingertip. The kit holds a single-use lancet, capillary collection tubes and a prepaid mailer. You drop it at FedEx the same day, a laboratory runs the panel, and results reach a dashboard in three to five business days. Membership is $124 for a first cycle and $149 after. Panels run from fourteen biomarkers to sixty, and the company says more than 50,000 people have used it.
The laboratory is not SiPhox. Across the company pages reviewed here it is described only as CLIA certified and CAP accredited, never named. In a 2023 thread on r/medlabprofessionals, an account identifying itself as a SiPhox co-founder and chief product officer put it plainly: “SiPhox partners with a major CLIA lab for its testing. SiPhox itself is not yet a lab.” Nothing found since names a successor.
That distinction carries weight. These are laboratory developed tests, ordered without a doctor in most states and run on capillary blood. The partner panel listings label individual markers capillary, a different specimen type from the venous tube a hospital draws. The consumer pages say the arm method avoids the interstitial fluid contamination that dogs finger sticks, and that results are validated against venous draws. No published comparison was found.
Two engineers with no medical background
Diedrik Vermeulen and Michael Dubrovsky met through MIT in 2019. Vermeulen had been a research scientist in the Silicon Photonics Group and director of engineering at Analog Photonics; Dubrovsky was in materials science. Neither had worked in medicine. They began filing patents in February 2020, took bench access through START.nano, and went through Y Combinator that summer. Their first product was a $1 COVID-19 test on a cartridge. The pandemic pushed them into biosensing and then immunoassays, which measure proteins and hormones by antibody binding. Blood cell counts were never on the menu.
“A lot of blood tests aren’t done because they’re too inconvenient,” Dubrovsky told MIT News in 2024. Vermeulen frames the engineering the same way each time: “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.”
The name everyone says out loud
Coverage reaches Theranos within four paragraphs, and SiPhox gets there first: it does not attempt the tests that broke Theranos, and clearance is promised before the home device goes on sale. John P.A. Ioannidis, a Stanford professor of medicine and one of the first scientists to raise the alarm about Theranos, gave the Globe a split verdict. “Testing, like any other medical procedures, requires some reason,” he said of routine screening. For people with chronic illness who already need repeated draws, though, “There’s some merit in allowing people to get a bit more control of their life.”
What is proven, and what is still claimed
| Evidence | What the record shows | Source type |
|---|---|---|
| FDA clearance | No 510(k) and no PMA in openFDA searches as of Sep 23, 2026. The only FDA footprint is an establishment registration for SiPhox, Inc. (FEI 3018308579, Burlington) and a device listing for SiPhox collection kit v1, v1.1 and v1.2 under product code PQD. A contract manufacturer in Indianapolis lists the same kits from Nov 2022. | Public record |
| What PQD means | Blood Specimen Collection Convenience Kit, class II, regulation 862.1675. The FDA classification record says this kit type “is under enforcement discretion, and does not require a premarket notification (510(k)) to market” under the 1997 convenience kit guidance. Registration is not clearance. | Public record |
| Who runs the samples | A third-party laboratory described as CLIA certified and CAP accredited, not named on any SiPhox page reviewed. | Company-stated |
| Test category | Laboratory developed tests on capillary specimens. The FDA rule that would have regulated such tests as devices was vacated in full on Mar 31, 2025 by a federal district court in Texas, so CLIA remains the operative framework. | Public record |
| Independent validation | Company pages say results are validated against venous draws and that third parties have validated the chip system. No report, method comparison or peer-reviewed paper was found. | Not found |
| Peer-reviewed literature | A PubMed search for SiPhox on Sep 23, 2026 returned four records, one about the company: a 2024 Trials protocol (REED, NCT06450951) that used SiPhox as a commercially available at-home test. That is a use of the product, not an evaluation of it. The trial completed Jun 30, 2026 with 1,074 enrolled. | Public record |
| Patents | Justia lists SiPhox, Inc. on four granted US patents and sixteen published applications, covering modular photonic assemblies, an in-body sensor circuit, an optoelectronic reader and an optical matrix multiplier. A home testing cartridge was filed Jan 5, 2026. | Public record |
| Non-dilutive funding | $681,631 from the Massachusetts Manufacturing Innovation Initiative, announced Jul 13, 2022, to lift biochip output from about 100 a month to roughly 5,000, using AIM Photonics 300 mm silicon photonics. No NIH or NSF award was found. | Public record |
| How the mail-in test gets described | MIT News wrote in 2024 that SiPhox provides mail-in testing “using approved technology.” A trade summary of it rendered that as FDA-approved technology. The FDA record shows no cleared or approved SiPhox test. | Differs from the record |
| State ordering rules | New York, New Jersey and Rhode Island restrict direct access lab ordering. A 2023 thread comment said SiPhox kits were unavailable in New York on that basis; a New York resident in that thread said a kit reached them anyway. | Unresolved |
Read plainly: SiPhox has a manufacturing base, a state grant, a patent estate and a paying consumer business. What it lacks is a cleared device, a named laboratory and one published method comparison. The business paying the bills is a mail-in wellness panel regulated as a laboratory service rather than a product, and the technology the company is named for has not yet reached a customer.
What to watch
- An FDA submission for SiPhox Home. SiPhox told TechCrunch in 2023 it was working toward clearance within a year, and the Globe reported in 2025 that a bedroom service was expected by 2026. Neither shows in the record.
- A named laboratory partner, or a CLIA certificate in SiPhox’s own name. Either would settle who is accountable for a result.
- A published method comparison against venous draws for the capillary panels now on sale.
- Whether the Series B that an SEC filing name points to in December 2025 is ever announced.
- Pricing pressure from Function Health, which raised $298 million at a $2.5 billion valuation in November 2025.
In their words
“A lot of blood tests aren’t done because they’re too inconvenient.”
Michael Dubrovsky, co-founder, MIT News, 2024 · Independent
“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.”
Diedrik Vermeulen, co-founder and CEO, MIT News, 2024 · Independent
“The real holy grail is to have it done immediately at home, because it cuts the cost by a factor of three.”
Michael Dubrovsky, The Boston Globe, 2025 · Independent
“Testing, like any other medical procedures, requires some reason.”
John P.A. Ioannidis, professor of medicine, Stanford, to The Boston Globe, 2025 · Independent
“There’s some merit in allowing people to get a bit more control of their life.”
John P.A. Ioannidis, on chronic disease monitoring, The Boston Globe, 2025 · Independent
“The technology is unproven. The application of their chips to clinical testing is mostly theoretical, and no studies have been published comparing their technology to established methods.”
Commenter, r/medlabprofessionals thread on SiPhox, 2023 · Independent
“SiPhox partners with a major CLIA lab for its testing. SiPhox itself is not yet a lab.”
Account identifying as SiPhox co-founder and chief product officer, r/medlabprofessionals, 2023 · Company-stated
Related companies
Sources
- Public recordopenFDA registration, listing and classification records, SiPhox, Inc. and code PQD
- Public recordForm D and Form D/A filings, SiPhox Inc., CIK 0001824002
- Public recordBaker-Polito Administration Awards $681,000 Grant to Burlington’s SiPhox
- Public recordPatents assigned to SiPhox, Inc.
- Public recordREED protocol, Trials PMID 39587613, and ClinicalTrials.gov NCT06450951
- Public recordFederal Court Vacates FDA Rule on Laboratory Developed Testing Services
- IndependentDo-it-yourself home blood tests may be available next year from this Burlington company
- IndependentBringing lab testing to the home
- IndependentIntel Capital, Khosla lead $27M investment into SiPhox Health
- IndependentIs this even leggit? Siphox Health claim to tests 17 biomarkers
- IndependentFunction Health raises $298M Series B at $2.5B valuation
- CompanyWhat Is SiPhox? and SiPhox Testing Process
- CompanyHow It Works, Programs and Partner
- CompanySiPhox Health company page and GLP Monitoring launch
Profile researched and written by Healthcare Discovery. Last updated September 29, 2026.
