NEW YORK – With the launch of its first product, a rule-out test for pancreatic cysts that can help risk-stratify patients who may have pancreatic cancer, Purdue University spinout Amplified Sciences is aiming to improve early cancer detection.
Using ultrasensitive dyes developed at Cofounder Vincent Jo Davisson's laboratory at Purdue, the company developed its test to "look optically at disparate types of biomarkers" and improve early cancer detection, said CEO Diana Caldwell. The dyes are most sensitive and accurate when used with surface-enhanced Raman spectroscopy (SERS), which forms the basis of the firm's technology.
The patented dyes are tagged to a biomaterial to create the test's reagents. When the reaction occurs, the dyes are cleaved and then light up to provide a visual signal when a biomarker is present in the sample. That visual signal is then read with the company's SERS technology using an instrument from Wasatch Photonics. The ultrasensitivity of the dyes "enables very low limits of detection and … small volumes of sample," Caldwell said.
"When there's low abundance or low volume, these dyes really can shine," she added.
By detecting the signal from the dyes rather than directly detecting a biomarker, the background noise in a sample decreases and the assay's sensitivity increases, Caldwell said. The test runs on the company's BioMatra platform, which combines spectroscopy hardware, chemometric tools, chemistry reagents, and machine-learning algorithms.
The lead analyte in the PanCyst Pro Panel is an undisclosed novel enzyme while the assay detects catalytic activity of the enzyme within a sample, she said. The test also includes two additional analytes and the machine-learning algorithm that determines whether a patient is high risk or low risk based on whether a cyst is mucinous or non-mucinous — a non-mucinous cyst is generally low risk, and cancer can be ruled out, Caldwell added.
Last year, the company published an abstract at the American Society for Clinical Oncology Gastrointestinal Cancers Symposium. According to the abstract, the test identified non-mucinous cysts with 99 percent sensitivity and a negative predictive value of more than 95 percent in 185 retrospective samples.
Davisson also published a paper in Diagnostics in 2022 describing and validating an earlier version of the assay. The test had an area under the curve of 0.87 and showed sensitivity of 80 percent and specificity of 90 percent in 69 retrospective samples.
Caldwell said Amplified Sciences also anticipates a "pivotal publication" coming soon that will provide further clinical validation for the test.
Amplified Sciences decided to focus on pancreatic cancer because there is a "big unmet medical need" for early detection of pancreatic cancer and because there are challenges when collecting pancreatic cyst fluid that the company felt its technology could assist with, Caldwell said. While pancreatic cyst fluid is often aspirated to help risk-stratify patients with pancreatic cancer, low sample volume is a persistent issue.
"Pancreatic cystic lesions are small, or they don't have a lot of fluid," Caldwell said. The fluid is also viscous and "doesn't come out as a pure liquid," so it is "oftentimes difficult to get a high volume," she added. Molecular tests like next-generation sequencing-based assays or PCR-based assays generally need a higher sample volume to work accurately, so there was a "need for a creative solution that was able to have ultrasensitivity."
A "more accurate tool" was needed to help rule out cancer in patients with pancreatic cysts, as well as to determine how aggressively they should be monitored and whether the cysts should be surgically removed, she added.
The number of patients with pancreatic cystic lesions is also increasing as the population ages and imaging technologies improve. As a result, the lesions can be discovered more quickly and with more accuracy, so there is an unmet need for a test that can stratify those patients by risk accurately, Caldwell noted.
Right now, the company is gearing up for an early-access program that will be conducted in partnership with an undisclosed healthcare system. The firm is also enrolling sites for a clinical utility study to gather data that is important for submission to payors for reimbursement and coverage of the test, Caldwell said.
West Lafayette, Indiana-based Amplified Sciences will initially market the assay as a laboratory-developed test and will run the test in its CLIA-certified laboratory in Irvine, California, but Caldwell noted that it will eventually pursue approval from the US Food and Drug Administration for its BioMatra technology platform and for the PanCyst Pro Panel.
The firm has also applied for a Proprietary Laboratory Analyses code from the US Centers for Medicare and Medicaid Services that will allow it to receive pricing from government payors.
The company has focused on the US market thus far because that is where it is based and because it is a smaller company, but Caldwell said that she has had conversations with clinicians and other potential partners outside of the US that could lead to clinical collaborations and partnerships.
The firm has received funding from the National Cancer Institute to develop a second test to help grade dysplasia using fluid from pancreatic cystic lesions, she said. It is also conducting studies to demonstrate the value of its technology in other sample types, including urine and blood, and in other cancers.
Amplified Sciences also has a test in development for use with tissue samples in another undisclosed oncology application, Caldwell noted.
Thus far, the company has raised $2.6 million from two rounds of funding with a mix of venture capital firms and angel investors and has received nearly $1.5 million of non-dilutive funding.
Amplified Sciences will join an increasingly crowded field of companies and research groups looking to improve early detection of pancreatic cancer. Swedish diagnostic firm Immunovia is preparing to launch its antibody-based PancreaSure test in the second half of this year and recently published new clinical validation data on the assay, while German cancer diagnostic company Mainz Biomed also last month announced a deal with Liquid Biosciences to develop a blood-based test for early detection of pancreatic cancer.
ClearNote Health's epigenetic Avantect Pancreatic Cancer test, meantime, recently received approval from the New York State Department of Health Clinical Laboratory Evaluation Program. Breakthrough Genomics is also working to validate its liquid biopsy next-generation sequencing-based test for early pancreatic cancer detection.
On the research side, Oregon Health and Science University published a study in February describing its protease-based assay for screening and detection of pancreatic cancer in patients with elevated risk. Johns Hopkins University researchers have also published data on a gene variant test for early detection of pancreatic cancer.