July 16, 2026 | Much like the trajectory of infectious disease diagnostics was changed by PCR and molecular methods, Epi One is looking to alter the course of cancer diagnostics with direct, highly sensitive molecular detection of specific epigenetic biomarkers of multiple malignancies. First out of the gate will be a prostate cancer re-biopsy decision tissue-based assay, immediately followed by an initial prostate cancer biopsy blood-based test, according to John Meduri, co-CEO of the biotechnology startup.
The test portfolio additionally includes blood-based tests for assessing indeterminate lung nodules and monitoring minimal residual disease in lung cancer patients and will expand to include assays for other cancers including breast and pancreatic cancers. Epi One has already developed a multi-cancer early detection (MCED) set of biomarkers that is expected to launch in a few years, Meduri says. Current pre-clinical performance of the MCED assay rivals that of current next-generation sequencing tests. After the latest fundraising round, the company will immediately begin the process of initiating its CLIA-lab permitting process through New York State—the regulatory prerequisite needed to perform laboratory-developed tests (LDTs).
Epi One’s molecular assays are directly targeting the global cancer death rate, which studies forecast will rise to over 18 million by 2050. Epi One believes that projection could be significantly reduced through early detection, says Meduri, an industry veteran who joined the company in February.
His co-CEO is Sophia Fang, M.D., Ph.D., who cofounded Epi One in 2016 with Neng Yang, M.D., Ph.D., vice president of research and development.
Meduri will speak about the value of capturing invisible transformational biology in speeding up cancer diagnostics at next month’s Next Generation Dx Summit in Washington, D.C. He will present the latest performance data from preclinical validation studies with Epi One’s prostate and lung cancer assays, all of which are PCR-based tests utilizing less than 10 biomarkers. Close to 1,500 patient samples have been tested thus far.
Results to date for the pancreatic cancer assay are superb, Meduri notes, and also personal to him due to the loss of a family member. “They were diagnosed on Halloween one year and they were no longer with us on Thanksgiving that same year.” Cancer is so common that most people have been similarly affected by a family member or close relative who has battled the disease.
“The goal is to democratize cancer diagnostics, making it available to every clinical laboratory around the world so we can truly impact the patient where they are,” Meduri says. “That’s difficult to do based on the technological advancements that have come about, especially on the molecular front with respect to next-generation sequencing and targeted sequencing.”
The blood-based tests of Epi One can produce test results in well-under seven hours, “basically the same shift,” and aims for an estimated cost of under $200 per patient, he continues. That could drastically reduce the cost of early detection and targeted treatment by intercepting diseases before they progress.
Meduri has personally witnessed that same evolution in the infectious disease testing space where Pasteurian methods gave way to advances in total lab automation and molecular diagnostics progressed from centralized, single-pathogen tests to decentralized, multiplexed syndromic testing near the patient. “Now’s the time to see similar transformations within cancer diagnostics,” he says.
Early in his career, Meduri was a clinical microbiologist at Hartford Hospital in Connecticut, where he also taught immunology. While he enjoyed providing diagnostic results that tangibly influenced patient care, a colleague convinced him he could impact many more patients by joining a diagnostic company. He took a position as a commercial representative for Becton Dickinson (BD), also being convinced that his teaching background and understanding of medical technology made him a “natural salesperson,” he recalls.
Meduri eventually moved in-house with BD to drive a lot of the company’s pre-commercialization activities, he says. “My passion over the years has been bringing innovation, and many times ‘big I’ innovation ... to significantly reduce human morbidity and mortality and improve healthcare economics for the global healthcare community.”
This has included many leadership roles within industry, the last before joining Epi One being the chief strategy officer for Accelerate Diagnostics. Meduri also was doing some consulting work for startup companies, including Epi One, which is how he became acquainted with the game-changing work of Drs. Fang and Yang.
For well over 100 years now, cancer has been defined based on the physical shape of cells as they appear under a microscope, Meduri says. But numerous companies, Epi One among them, have shown that cancer starts as a molecular disease, and the biological shifts happen imperceptibly deep inside the cell long before any physical damage occurs.
One of the lessons learned on his journey is that it invariably takes longer than anticipated for even the best-performing assay to gain clinical acceptance, says Meduri. A test needs to prove it delivers the promised clinical and economic outcomes for the targeted populations and needs to be written into order sets within hospitals, which means approaching different healthcare stakeholders as well as professional societies to ensure they endorse the new evidence-backed technology so it receives the reimbursement it deserves and out-of-pocket costs are negligible to patients.
Even then, he continues, “it takes time and perseverance to change the practice of medicine, but the fruits of these labors are undeniable.”
Epi One hasn’t yet commercialized any of its assays. The first order of business is to receive a CLIA permit for its own lab, based in New York City, Meduri says.
“That will allow us to start early revenue generation ... [by] testing clinical specimens from around the country and initiating healthcare economic outcome research studies,” he explains. The company wants to generate proof in peer-reviewed publications that its assays enable a significant reduction in morbidity and mortality associated with the various cancers.
“At that point, we will begin porting the assays onto various molecular systems already in routine clinical use worldwide,” says Meduri. Several multinational corporations with established molecular instrumented platform solutions (e.g., syndromic molecular and digital PCR-based systems) on the market have already begun lining up for the opportunity, he adds.
“Ultimately, we want to bring our assays as close to the patient as possible, so rather than sending specimens out to a reference laboratory a pathologist could, in line with the oncologist, order our assays in the clinic or in the hospital and get results the very same shift,” he says. “That’s really a breakthrough in cancer diagnostics ... [and] just not possible today even with the emerging next-gen sequencing testing that’s done, mostly in LDT CLIA laboratories sponsored by Guardant [Health], GRAIL, and Exact Sciences.”
The first product introduced to market will be the prostate re-biopsy decision assay, which involves taking a fresh tissue sample and sending it to Epi One’s lab to assess whether cancer is present when patients with PI-RADS 4 or 5 lesions (based on MRI-guided biopsies) ultimately have benign biopsies. This initial assay will inform clinicians whether future biopsies will be necessary. In preclinical validation studies with hundreds of tissue samples, the test has an area under the curve score in the high 90s, meaning excellent sensitivity and specificity, says Meduri.
That assay will launch in the U.S. initially as an LDT while real-world evidence studies are being conducted to substantiate company claims, he says. Epi One plans to gain its own proprietary reimbursement code for the assay.
Next up will be the prostate cancer initial biopsy test, which has similarly high overall accuracy, and will allow urologists, oncologists, and pathologists to determine if an initial biopsy is required based on molecular-level analysis of a blood sample. After that will be the triage test for lung nodule indeterminate results from a prior imaging study to rule cancer in or out.
Since time to results is calculated from the point a sample is received, findings over the near term will reach clinicians within one to two days. As oncologists indicated in a recent Labcorp survey, test turnaround time is a number one hurdle delaying early cancer detection, Meduri points out.
Ultimately, when the MCED test is released, the goal is to target high-risk and symptomatic populations, including patients under the age of 50, he adds. “That’s where we think our MCED assay is really going to provide significant benefit to the global community.”