Amplified Sciences Secures CLIA Certification for Pancreatic Test
Breakthrough for Pancreatic Cancer Detection
Amplified Sciences, a pioneering life sciences diagnostic company, has achieved CLIA certification for its innovative test, PanCystPro™. This advance is a significant milestone in the early detection of pancreatic cancer, a notorious disease known for its high mortality rate. The test's development aims to provide healthcare professionals with tools to identify patients at risk before the disease manifests.
The Importance of CLIA Certification
Receiving CLIA certification signifies that Amplified Sciences has met the stringent requirements set forth by the Clinical Laboratory Improvement Amendments. This regulation ensures that laboratories maintain high standards of accuracy and reliability in diagnostic testing. The certified lab, situated in California, is now poised to offer PanCystPro™ as part of its diagnostic services.
What is PanCystPro™?
PanCystPro™ is designed to help identify individuals diagnosed with pancreatic cystic lesions, a precursor to pancreatic cancer. This test analyzes biomarkers that provide crucial insights into the potential malignancy of cystic lesions, thus aiding in timely intervention and treatment planning.
Expert Insights into the Testing Process
The test leverages advanced technology to analyze enzymatic activity specific to the pancreas. According to V. Jo Davisson, chief scientific officer, this protease turnover assay plays a pivotal role in determining whether a pancreatic cyst poses a risk for cancer development.
The Clinical Relevance of PanCystPro™
Amplified Sciences' CEO, Diana Caldwell, emphasized the pressing need for effective diagnostic tools in combating pancreatic cancer. She referenced statistics revealing the disease's position as one of the deadliest cancers, with very few discernible symptoms in its early stages, which drastically lowers survival rates.
Future Plans and Milestones for Amplified Sciences
With CLIA certification secured, the company is now focusing on the commercialization of PanCystPro™. Key initiatives include launching a pivotal clinical utility trial aimed at further validating the test’s effectiveness and providing access through early access programs to select healthcare systems in the coming years.
Exploring Innovations in Cancer Detection
Furthermore, Amplified Sciences is working on obtaining a Proprietary Laboratory Analyses (PLA) code. This will facilitate the establishment of reimbursement rates for the test, thereby making it more accessible to patients through Medicare.
Partnerships and Collaborations
Amplified Sciences has an ongoing partnership with Purdue University, which has significantly contributed to its technological advancements. The company’s optical reporter system, BioMatra™, is derived from proprietary technology developed at Purdue, showcasing the synergy between academic innovation and commercial application.
The Role of Purdue University
Purdue University has been instrumental in the growth of Amplified Sciences, especially through its Office of Technology Commercialization. This office assists in bringing research innovations to market, ensuring that groundbreaking technologies benefit patient care directly.
Conclusion
As Amplified Sciences moves forward with its ambitious plans, the successful rollout of PanCystPro™ could revolutionize the way pancreatic cancer is detected and treated. With a focus on improving patient outcomes through innovative diagnostics, this company is at the forefront of tackling one of the most challenging cancers faced today.
Frequently Asked Questions
1. What is CLIA certification?
CLIA certification indicates that a laboratory complies with the regulations set forth for quality laboratory testing, ensuring accurate and reliable results.
2. How does PanCystPro™ work?
PanCystPro™ evaluates enzymatic activity in pancreatic cystic lesions to gauge the risk of cancerous changes.
3. Why is early detection of pancreatic cancer important?
Early detection significantly improves treatment outcomes, as pancreatic cancer often progresses silently, leading to late-stage diagnosis.
4. What are the next steps for Amplified Sciences after receiving CLIA certification?
The company plans to commercialize PanCystPro™ and initiate clinical trials to further establish its utility in cancer detection.
5. How can I learn more about Amplified Sciences?
For more information, you can visit Amplified Sciences' official website or consult press releases related to their ongoing research and products.
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