Medical devices & diagnostics · Digital pathology
Instapath
A fluorescence microscope that turns a fresh, uncut biopsy into an image resembling a stained slide, in minutes. The device is listed with the FDA as a Class I microscope, with no clearance, no registered trial and no named customer on the record.
Two to three minutes
A radiologist pulls a core of tissue through an 18 gauge needle. In the standard workflow that core goes into formalin, then paraffin, under a microtome, onto glass, into a stain bath. A pathologist reads it days later.
Instapath proposes a different path. The core goes into a cartridge, is bathed in two fluorescent dyes chosen so the image mimics hematoxylin and eosin, and is imaged whole by a structured illumination microscope. Nothing is cut or fixed. The tissue comes out intact and can still go to the pathology lab and to molecular testing.
A trade podcast that interviewed the company in 2023 put a number on it. “For an 18-gauge biopsy the time from tissue removal from the body, through fluorescent staining, image processing, and upload to the image viewer is between two and three minutes.” The Y Combinator line is blunter: “We built the world’s first automated digital pathology lab.”
What happens while you wait
The pitch that carried Instapath through four competitions in 2017 was repeat biopsies. Doctors sample a lesion, send it away, and learn later that the sample missed or was too small. An Inc. feature sponsored by Cox Business that year reported that “one in five patients will receive an inconclusive result on a biopsy”, and that of roughly 5 million US biopsies a year, about 1 million lead to a repeat.
Tools for reading fresh tissue at the bedside already exist. Frozen section takes about twenty minutes, destroys part of the sample, and needs a pathologist in the building. Touch preparation cytology is fast but insensitive, and both do poorly on fatty breast tissue. That is the opening Instapath is aimed at.
The field is crowded and nobody has won the argument. A 2019 review in Archives of Pathology & Laboratory Medicine surveyed confocal, optical coherence tomography, light sheet, Raman and structured illumination and concluded: “Very few of these platforms are available commercially for imaging tissues in surgical pathology practice, and all of them are currently investigational.”
A lab, and four people out of it
The technology started in J. Quincy Brown’s lab at Tulane. The company’s about page says so: “The idea of high-resolution, rapid imaging microscopy for slide-free pathology was born in our founders’ biomedical engineering lab at Tulane University.”
Mei Wang, a Tulane biomedical engineering PhD, is co-founder and CEO. David Tulman and Peter Lawson came through Tulane’s bioinnovation PhD program. Brown, the faculty member, is listed by Y Combinator as a founder and appears in early coverage as scientific advisor. In 2017 the four won the Get Started Louisiana pitch prize at New Orleans Entrepreneur Week, took a $12,500 prize at Tulane’s Novel Tech Challenge, and beat 38 teams to a $30,000 grand prize at the International Business Model Competition in Mountain View.
Wang described the customer research to Cox BLUE the following year: “After interviewing over 200 physicians, we found that the physicians are still using technology from over 100 years ago for biopsy quality evaluation.”
From a campus lab to a medical center suite
Instapath incorporated in Delaware in 2017 and took NSF money early: an STTR Phase I award of $225,000 from July 2018, with Wang as principal investigator and Brown as co investigator, performed at Tulane. The company went through Y Combinator in Winter 2019 and filed its only Form D that September, by then from a Houston address inside the Texas Medical Center.
A larger NSF award followed in March 2021 and runs into 2027. In May 2024 Instapath was granted its first patent in its own name and registered a fluorescence microscope with the FDA as a Class I device. In March 2025 Wang told Tulane’s business school magazine: “our Neo system is now registered as a Class I medical device, and we are actively engaging in market entry efforts”.
What is proven, and what is still claimed
| Evidence | What the record shows | Source type |
|---|---|---|
| Accuracy, prostate | A 2015 Cancer Research study imaged 34 uncut prostate punch biopsies. Per a 2019 review: “The sensitivity ranged from 63% to 88% and specificity from 78% to 89% in this first study that used SIM for rapid evaluation of human tissue.” A 2023 Cancers study imaged 39 patients on site, averaging 145 seconds each. | Peer reviewed |
| Accuracy, breast | PLOS One, 2024, 47 fresh breast biopsies read by one pathologist untrained on the images: “a 92% sensitivity, 97% specificity, and 96% accuracy was achieved when binary diagnoses from SIM images were compared to diagnoses obtained from subsequent histology slides”. The authors call it preliminary. | Peer reviewed |
| Whose instrument was tested | Those studies used customized systems built in the Tulane lab, not a commercial unit. The 2024 competing interest statement reads: “JQB is a co-founder and officer of Instapath, Inc., which however did not support the work presented here.” No published study evaluates Neo or Luci. | Gap between paper and product |
| FDA status | Registration 3016418391, correspondent David Tulman. One listed product under code IBK, “Microscope, Fluorescence/U.V.”, 21 CFR 864.3600, class 1, listed May 30, 2024. The 510(k) and PMA databases return no records. The company calls the registered device Neo; the FDA listing carries the name Nova. | Public record |
| Research only product | Instapath’s Luci page states: “This device is not approved by the FDA for clinical use”. | Company-stated |
| Federal grants | NSF STTR Phase I 1820258, $225,000. NSF SBIR Phase II 2039417, $1,499,999 obligated across FY2021 and FY2023, to February 2027. Total $1,724,999. The Phase I outcomes report on 30 prostate biopsies: “The study pathologist was able to identify 4 out of 5 samples using the VR-SIM images alone.” | Public record |
| NIH money | No awards to Instapath. The underlying science was funded at Tulane through Brown, via NCI grants R33CA196457 ($945,617, FY2015 to FY2017) and R01CA222831 ($1,594,733, FY2018 to FY2021). | Public record |
| Patents | US11988584B2, “Disposable biopsy staining kit and related methods and systems”, granted May 21, 2024 to Instapath, Inc. The core patent US10768402B2 is assigned to Tulane University of Louisiana. | Public record |
| Trials and customers | No trial registration for Instapath on ClinicalTrials.gov, and no named hospital, clinic or biobank customer in any public source, as of Sep 22, 2026. | Not found |
Read plainly: the science has been tested on patient tissue, published in peer reviewed journals, and reproduced across three organ sites. What has not been tested in public is the product. Every accuracy number on the record belongs to a bench system in a university lab, and the commercial instrument reached the market through a Class I listing, which is a notification that a device exists, not a finding that it works. That is a legitimate route for a microscope. It is also why there is nothing to read.
What to watch
- Whether Instapath files a 510(k). A Class I listing supports selling a microscope; a diagnostic claim would need a different submission.
- A study registered under the company’s own name, using the shipping instrument rather than a bench rig.
- A named customer. Seven years after Y Combinator, none has been identified publicly.
- The NSF Phase II award, which runs to February 2027. Its stated deliverable is verification and clinical validation of the integrated system.
- Any new SEC filing. The only Form D on record is from 2019, and Y Combinator lists the team at six.
In their words
“After interviewing over 200 physicians, we found that the physicians are still using technology from over 100 years ago for biopsy quality evaluation.”
Mei Wang, co-founder and CEO, Cox BLUE, 2018 · Interview
“For a medical device, it’s typical to take about six to 10 years from a prototype to an actual product on the market.”
Mei Wang, Inc. sponsored feature, 2017 · Interview
“This prize will help us accelerate testing of the new platform in partnership with several major cancer centers in Louisiana and New York so we can get it approved for widespread use in hospitals within the next few years.”
David Tulman, co-founder, Silicon Bayou News, 2017 · Independent
“Our goal was to transform digital pathology and cancer management by eliminating the need for time-consuming and destructive cutting steps”
Mei Wang, Tulane Freeman News, March 2025 · Independent
“our Neo system is now registered as a Class I medical device, and we are actively engaging in market entry efforts”
Mei Wang, Tulane Freeman News, March 2025 · Independent
“Very few of these platforms are available commercially for imaging tissues in surgical pathology practice, and all of them are currently investigational.”
Archives of Pathology & Laboratory Medicine, 2019 · Peer reviewed
“JQB is a co-founder and officer of Instapath, Inc., which however did not support the work presented here.”
Competing interests statement, PLOS One, May 2024 · Peer reviewed
Related companies
Sources
- Public recordopenFDA device registration and listing, registration 3016418391, code IBK
- Public recordopenFDA 510(k) and PMA searches, applicant Instapath, no records
- Public recordNSF awards 1820258 and 2039417, with outcomes report
- Public recordNIH RePORTER, Tulane awards to J. Quincy Brown; none to Instapath
- Public recordForm D, Instapath Inc., CIK 0001788885
- Public recordUS10768402B2 and US11988584B2 assignment records
- Peer reviewedStructured illumination microscopy for cancer identification in diagnostic breast biopsies
- Peer reviewedRapid On-Site Microscopy and Mapping of Diagnostic Biopsies
- Peer reviewedEx Vivo Microscopy: A Promising Next-Generation Digital Microscopy Tool
- InterviewVirtual H&E. How Instapath uses optical sectioning microscopy
- InterviewWhere Are They Now: Mei Wang of Instapath
- IndependentInstapath Bioptics Wins Get Started New Orleans 2017
- IndependentTBMC Past Winners: A faster, better way to perform pathological evaluations
- IndependentTulane Team Wins International Business Model Competition
- IndependentInstapath Wins Tulane Novel Tech Challenge
- CompanyInstapath home, about, products, Neo and Luci pages
- CompanyInstapath Inc. profile, Winter 2019 batch
Profile researched and written by Healthcare Discovery. Last updated September 29, 2026.
