WEST LAFAYETTE, INDIANA, March 14, 2023 (GLOBE NEWSWIRE) -- A series of early-detection diagnostic tests under development by a Purdue-sponsored startup may commute the death sentence often associated with pancreatic cancer.
The devastating disease – the third most deadly cancer and the cause of death for Alex Trebek, John Lewis, Steve Jobs, Sally Ride and Aretha Franklin – kills 74 of every 100 victims within a year of diagnosis, largely because it is rarely discovered early enough to treat successfully.
Amplified Sciences Inc. aims to change that. Its patented tests use dyes to identify the potential for malignancy in fluid extracted from a cyst on the pancreas. These cysts, when accurately assessed, can provide a window to earlier detection.
“Earlier detection, followed by surgical removal, has a much better prognosis,” said Diana Caldwell, Amplified Sciences’ chief executive officer. “We also hope that, with early detection, scientists can identify interventions that can impact early stage pancreatic cancer. That’s a principle of cancer treatment – the earlier you get it, the more likely pharmaceuticals and other therapies are able to resolve it.”
Amplified Sciences’ tests that are in development are designed to confirm the risk that cancer will develop, said Vincent Jo Davisson, their inventor and the company’s chief scientific officer. The test results also may relieve the worries of a patient whose cyst is not malignant. Such a breakthrough could reduce the number of inaccurate diagnoses, said Davisson, a professor of medicinal chemistry and molecular pharmacology at Purdue University since 1989.
“Early disease detection is something I’ve been drawn to for a long time,” Davisson said. He started Amplified Sciences intending to develop and commercialize a screen for chronic kidney disease, but investors weren’t interested; they viewed it as too risky, he said. Then a “collusion of multiple things” turned his attention to pancreatic cancer diagnosis, including relevant professional connections and personal considerations: Six people in his life had died of pancreatic cancer. One of them was misdiagnosed three times before the cancer was confirmed, too late.
He invested a sizeable amount of his own money, and took his invention in 2016 to Purdue Foundry, a hub created by Purdue Research Foundation to provide practical entrepreneurial support to startup companies created by Purdue faculty members and students. There he met Caldwell, an entrepreneur-in-residence who previously worked more than 15 years at Eli Lilly and Co. and later co-founded a company that guides drug, device and diagnostic companies through clinical trials and regulatory requirements.
Davisson’s startup got its first external validation in 2016 and 2017, when it won black and gold awards totaling $100,000 from Elevate Ventures. Those proof-of-concept funds enabled him, Caldwell said, “to demonstrate outside of his research lab the power, flexibility and cost-effectiveness of these dyes,” publish his results and emerge from “the valley of death” that kills off many embryonic scientific ideas.
Soon after meeting in 2018, Davisson and Caldwell decided to combine their respective talents to grow Amplified Sciences and ultimately commercialize the tests.
Progress has been steady since. The pancreatic cancer test has been used in clinical samples and is ready for translation to a clinical lab and to enter the regulatory process. The company’s team, which includes three Ph.D. scientists is set to expand soon, has begun research and development on additional assays.
Investors have responded positively to these tests, which “are all based on functional properties of the biomarkers, which I think has been an unmet or a lost opportunity in the diagnostic industry for a long, long time,” Davisson said. Pancreatic cancer’s lethality – “once you’re diagnosed with it, you get your affairs in order because the end is near,” he said – makes for a compelling story for investors, who see the work as “a very high-value proposition.”
To date, the company has raised $1.8 million from several investors, according to Crunchbase and, despite it being what Caldwell called “one of the worst capital-raising markets we’ve seen in years,” she expects to announce shortly that it has made significant progress in the company’s latest fundraising round, with a goal of $3 million.
Because Davisson invented the dyes in his Purdue lab, the university owns the intellectual property; Amplified Sciences holds an exclusive license to advance it. Profits realized when the tests are commercialized will be shared.
Caldwell credited what she called “the Purdue ecosystem” for enabling Amplified Sciences to advance this far. The Foundry, she said, helped the company identify appropriate markets and provided expertise from entrepreneurs-in-residence, a position she previously held. She is a member of a group created by the foundry of “like-minded and similar-stage CEOs” that is moderated by a professional who provides business coaching. Purdue also provides Amplified Sciences’ scientists with access to expensive lab instruments that the company could not afford. In addition, university faculty members are available for collaboration.
“We really value the Purdue ecosystem resources and culture that are favorable toward startups,” she said. “We are partnering with other academic institutions across the country now via collaborations and clinical-sample agreements, but it’s so fortunate that our hometown institution is key for our success.”
The future looks promising, but it also holds some challenges besides those in the laboratory. If the tests meet regulatory approval, more gastroenterologists will have to be trained to retrieve fluid from pancreatic cysts, a procedure not typically taught to all gastroenterologists in medical school, Davisson said.
In addition, Amplified Sciences must persuade insurance companies and Medicare to authorize and pay for a test when a physician orders it. A clinical utility study will be conducted to demonstrate to payers the value and impact of the test on clinical decisions.
Ultimately, “the patient is waiting,” Caldwell said. “And the patient is waiting for us, all of us in the industry, to deliver these life-saving diagnostics to them. It is an awesome responsibility.”
Writer: Mary Dieter
Source: Diana Caldwell, diana.caldwell@amplifiedsci.com
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