Amplified Sciences Achieves CLIA Certification for New Cancer Test

Amplified Sciences Receives CLIA Certification

Amplified Sciences, a clinical-stage life sciences diagnostic company, has made significant strides in early cancer detection by obtaining regulatory clearance under the Clinical Laboratory Improvement Amendments (CLIA) for its groundbreaking product, PanCystPro™. This product serves as a vital tool for assessing the risk of pancreatic cancer, aiming to enhance the accuracy of diagnoses in patients with pancreatic cystic lesions.

About the PanCystPro™ Test

The new CLIA-certified laboratory operated by Amplified Sciences is located in Irvine, California, and is fully licensed by the state's Department of Public Health. The laboratory will conduct the PanCystPro™ test, designed to stratify patients known to have pancreatic cystic lesions, which are precursors to pancreatic cancer.

Scientific Insights Behind the Test

V. Jo Davisson, the Chief Scientific Officer at Amplified Sciences, who also serves as a professor at Purdue University's College of Pharmacy, emphasizes that the PanCystPro™ incorporates a protease turnover assay. This innovative test identifies specific enzymes typically associated with the pancreas, providing crucial biological insights that can indicate the malignancy potential of the cysts.

Addressing the Need for Early Detection

Poverty Caldwell, the CEO of Amplified Sciences, expressed her enthusiasm regarding the introduction of the PanCystPro™ test. "Pancreatic cancer is notably challenging due to its low survival rates, typically linked to late detection," Caldwell highlighted. "With so few warning signs early on, our test aims to provide vital information to healthcare professionals, enabling them to make informed decisions for their patients suffering from this devastating illness."

The Role of Education and Awareness

According to recent studies, pancreatic cancer is the third leading cause of cancer-related deaths in the United States. This underscores the importance of awareness campaigns and educational efforts directed toward both clinicians and patients. Caldwell remarked, "Understanding the relationship between pancreatic cystic lesions and cancer risk is crucial for early detection efforts. Our mission is to offer clarity through innovations in diagnostics."

The Path Forward for Amplified Sciences

PanCystPro™ marks a significant starting point for Amplified Sciences' plans in commercializing its diagnostic capabilities. The company intends to conduct pivotal clinical trials to establish the test's utility further. Caldwell mentioned the introduction of an early access program in 2025, allowing targeted healthcare systems to utilize PanCystPro™ as part of their care protocols.

Regulatory and Financial Milestones

As part of their ongoing efforts, Amplified Sciences has filed for a Proprietary Laboratory Analyses (PLA) code, which is essential for determining a standardized payment rate through the Medicare Clinical Lab Fee Schedule once it is approved. Such actions reflect the company’s commitment to ensuring that its innovative diagnostic solutions are accessible to a broader patient population.

Collaborative Innovations with Purdue University

At the core of Amplified Sciences' advancements is the BioMatra™ optical reporter system. This cutting-edge technology is a result of extensive research and development at Purdue University, where Davisson and his team have pioneered various diagnostic tests.

The Legacy of Partnership

Partnerships like that with Purdue Strategic Ventures are vital for Amplified Sciences. The support from such entities enables the company to secure funding, as evidenced by the successful $2.6 million Series Seed Preferred capital raise. This investment exemplifies the robust support network that surrounds Amplified Sciences in its mission to revolutionize early cancer detection.

Frequently Asked Questions

What is PanCystPro™?

PanCystPro™ is a diagnostic test developed by Amplified Sciences to assess the risk of pancreatic cancer in patients with pancreatic cystic lesions.

Why is CLIA certification important?

CLIA certification ensures that the test is compliant with federal regulations, demonstrating that it meets high standards for laboratory testing and accuracy.

How does the test benefit patients?

The test helps healthcare professionals identify patients at higher risk of developing pancreatic cancer, potentially leading to earlier intervention and better outcomes.

What future plans does Amplified Sciences have for PanCystPro™?

The company plans to conduct clinical trials and initiate an early access program to provide the test to healthcare systems in a controlled manner.

How does collaboration with Purdue University aid Amplified Sciences?

Collaboration with Purdue allows Amplified Sciences to leverage advanced research, gain access to innovative technologies, and secure funding from strategic ventures, bolstering the company’s growth trajectory.

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