CHICAGO — Cancer diagnostics firm Mercy Bioanalytics took first place in the Disruptive Technology Award Competition at the Association for Diagnostics & Laboratory Medicine's annual meeting here on Monday.
The Waltham, Massachusetts-based company is pursuing an extracellular vesicle-based approach to early cancer detection, with an initial focus on ovarian and lung cancer.
Mercy believes that analysis of extracellular vesicles (EVs) could enable more sensitive early detection than the circulating tumor DNA-based approaches that have to date dominated the liquid biopsy and blood-based early detection spaces.
In many early-stage cancers, "there just isn't very much circulating tumor DNA available in the blood to measure," Mercy CEO Dawn Mattoon told 360Dx prior to the competition. EVs, by contrast, "exist at high abundance in circulation," she said. These membrane-bound particles are shed by cells, including tumor cells, into the blood stream, and their contents can reflect the biology of their cells of origin. This has made EVs an area of emerging interest within oncology, with a number of industry and academic outfits exploring their use.
Mercy's testing platform measures tumor-associated proteins present on the surface of EVs. The company's tests detect combinations of surface proteins, with three tumor-associated proteins required to be present on an EV to trigger a positive result. This allows for high specificity, Mattoon said, noting that while it is possible one tumor-associated protein might be present on an EV derived from a healthy cell, the likelihood that three different such proteins would be present "is very low."
Mercy detects the presence of these protein combinations using a proximity ligation assay in which antibodies to the target proteins are tagged with pieces of complementary single-stranded nucleic acids. When those antibodies bind to their targets, the complementary nucleic acids anneal and produce a nucleic acid strand that can be read out via PCR. To date, Mercy has relied on well-established tumor-associated proteins for its tests, as opposed to identifying novel biomarkers via its own discovery work.
Mercy's lead product, called Halo, is a blood test for the early detection of ovarian cancer. At the recent annual meeting of the American Society of Clinical Oncology (ASCO), the company presented data on patients sampled within 12 months of their diagnoses in which the test performed with 82 percent sensitivity and 98 percent specificity. It showed 85 percent sensitivity for stage I and II tumors. The test detected 15 percent of cancers in patients sampled between two and three years prior to their diagnosis.
Some experts raised questions about the test's specificity for high-grade serous ovarian cancer, however, as this form of the disease is responsible for the majority of ovarian cancer deaths.
Nonetheless, the test received breakthrough device designation from the US Food and Drug Administration in May, and Mattoon said Mercy aims to submit it to the FDA for premarket approval in the first half of 2026. In her presentation during the competition, Mattoon said the company intends to use the test as a tool for annual screening of post-menopausal women and plans to price it at around $200.
The company's second product is an EV-based blood test for lung cancer, which Mattoon said is intended to capture high-risk patients who have not undergone lung cancer screening by low-dose computed tomography (LDCT), which the United State Preventive Services Task Force recommends for current and former heavy smokers. Despite this recommendation, only a small proportion of eligible individuals receive LDCT screening.
"It's our view that a blood-based lung cancer screening test would go a long way toward bringing additional folks into that screening test," Mattoon said.
Mercy, which has roughly 40 employees, is in the middle of a Series B funding round targeting $80 million, which Mattoon said will allow the company to accelerate its FDA submission. The firm closed a $41 million Series A round in April 2023.
While the competition's judges — Richard Creager, managing partner at NaviDx Consulting; Kimberly Gasuad, senior VP of business development & strategy at Ibex; and Nancy Sullivan, CEO and managing director of Illinois Ventures — awarded Mercy top prize, the audience, which was also given a vote, chose a different winner, Utrecht, Netherlands-based Vitestro. Last year's competition also saw a split between the judges' and audiences' decisions.
Vitestro has developed an autonomous phlebotomy system that uses ultrasound-guided robotic needle insertion to conduct blood draws without the need for a human phlebotomist. The company won 56 percent of the audience vote with Mercy taking 36 percent and the competition's other participant, precision psychiatry firm Dionysus Digital Health, taking 9 percent.
Vitestro is positioning its technology to address the shortage of phlebotomists currently facing the healthcare industry while also reducing preanalytical error rates by automating and standardizing the blood collection process, Luuk Giesen, the firm's chief medical officer told 360Dx.
In May, the company reported initial results from its Autonomous Blood Drawing Optimization and Performance Testing (ADOPT) study. According to the study, 95 percent of draws were successfully conducted on the first attempt, on par with manual phlebotomy. Eight-three percent of patients rated the pain of the draw as less than or comparable to a manual draw. The hemolysis rate was 0.6 percent, which exceeded the American Society for Clinical Pathology's benchmark of 2 percent. The two-year study will ultimately test the device in 10,000 patients and will run through 2025.
During the competition, Vitestro Cofounder and CEO Toon Overbeeke said the firm received a CE mark for the device three weeks ago and has sold 10 devices to four customers in the Netherlands and Denmark.
He noted that the company is initially targeting the system to central phlebotomy departments within hospitals and that it plans to target large private laboratory firms with smaller locations like doctor's offices and retailers afterward. He said Vitestro is currently in discussions with several large European lab companies about setting up clinical trials of its instrument. The company is also in discussions with a number of large US hospitals about establishing research partnerships exploring the utility of its device in the US, Overbeeke said. It hopes to make an FDA submission next year.
Vitestro announced in April that it closed a $22 million funding round, which it said it will use to speed commercialization of its device. In total, the company has raised $50 million in grant and equity funding since it launched in 2017. Overbeeke said the company aims to close a Series B round of $50 million to $70 million next year.
San Diego-based Dionysus Digital Health rounded out the competition. The company has developed an epigenetic test for identifying pregnant women's risk of developing postpartum depression. The test assesses the methylation status of the genes TTC9B and HP1BP3, which research by Zachary Kaminsky, Dionysus cofounder and University of Ottawa associate professor, and others have linked to the condition.
The company has received $415,000 from the National Institutes of Health as part of the RADx Tech for Maternal Health Challenge and has raised $1 million in seed funding. Dionysus has also received a $6 million grant from the US Department of Defense, Cofounder and CEO Andrea Cubitt told 360Dx.
Cubitt said the company is currently in the process of preparing a de novo submission for the FDA. She said that Dionysus ultimately aims to apply its epigenetic approach to a number of other psychological conditions as well as to better predicting which psychiatric drugs will be most effective in which patients.