Newsroom — Singlera Genomics

On October 1, 2024, Singlera Genomics is pleased to share an exciting update on our Taizhou project. Our innovative multi-cancer early detection (MCED) tests are now being evaluated through large-scale population screening, with over 20,000 participants enrolled. This initiative is a significant step toward revolutionizing cancer screening by enabling early detection of multiple cancers from a single blood test. Our technology promises to improve healthcare efficiency and outcomes worldwide.

Read more about these advancements here.

Singlera Genomics Achieves Significant Breakthrough: ColonAiQ® Granted NMPA Certification for Colorectal Cancer Screening

🕒 May 14, 2024

Shanghai, May 14, 2024 – We are excited to announce that our cutting-edge product, ColonAiQ® - a targeted gene methylation combined detection reagent kit using the PCR-fluorescence probe method, has received official approval from the Chinese National Medical Products Administration (NMPA). This approval, resulting in a Class III medical device registration certificate, represents a monumental achievement in the early detection and diagnosis of colorectal cancer.

ColonAiQ® is the fruit of extensive research and innovation conducted by our dedicated R&D team. It signifies a significant leap forward in oncology by offering a non-invasive, highly sensitive, and specific approach for the early detection of colorectal cancer through methylation changes in specific genes. The NMPA certification reaffirms ColonAiQ®'s reliability, safety, and clinical relevance, establishing a new benchmark in cancer diagnostics.

Qiang Liu, COO of Singlera Genomics, expressed his enthusiasm, stating, "This accomplishment is a source of great pride for us and holds the potential to alter the lives of millions globally. The key to combating colorectal cancer lies in early detection, and ColonAiQ® brings us closer to making comprehensive, early screening a feasible goal. This certification not only recognizes our team's unwavering commitment and perseverance but also marks a significant step in our continued dedication to enhancing personalized medicine and patient care."

The NMPA's approval of ColonAiQ® marks a crucial milestone for Singlera Genomics and the future of colorectal cancer screening. By offering a non-invasive and precise testing option, Singlera aims to promote earlier and more frequent screenings, ultimately aiming to save lives through timely detection and treatment.

Singlera Genomics Secures a Milestone Patent for Revolutionary Genetic Analysis Technology

🕒 April 23, 2024

Singlera Genomics, Inc. is thrilled to announce a significant milestone in our journey toward revolutionizing genetic and genomic analysis. Our pioneering efforts have been officially recognized with the awarding of Patent Number 11965157. This patent covers the innovative compositions and methods for constructing polynucleotide libraries and/or polynucleotide sequencing, including related kits and devices, which are integral to our Titan and mTitan Technology and products.

This patented technology marks a significant leap forward by enhancing the ligation efficiency and conversion rate during sequencing processes. It represents a major advancement in genetic research and diagnostics. Specifically, our technology offers targeted solutions for analyzing polynucleotide fragments, including circulating tumor DNA and other circulating polynucleotide fragments. This opens new pathways for the detection and understanding of various diseases at the molecular level, providing a foundation for more effective treatments and diagnostics.

This achievement underscores the dedication, creativity, and hard work of our team at Singlera Genomics, Inc. We extend our heartfelt gratitude and congratulations to the inventors, Jeffrey Gole, Athurva Gore, and Rui Liu, whose contributions have been instrumental in reaching this milestone.

Our mission to advance the frontiers of genomics and personalized medicine is further invigorated by this accomplishment. We are eager to leverage our patented technologies to support researchers, clinicians, and patients worldwide, offering new insights and possibilities in genomic analysis.

Stay tuned for further updates and insights on how our patented technologies are paving the way for future breakthroughs in genomic analysis.

Link: https://ppubs.uspto.gov/dirsearch-public/print/downloadPdf/11965157

Breakthrough Genomics Collaborates with Singlera Genomics to Launch Revolutionary Pancreatic Cancer Screening Service in California

🕒 May 6, 2023

On May 6, 2023, Breakthrough Genomics, a company based in the United States, launched early cancer screening and testing services in California. The launch ceremony was attended by Fiona Ma, the Treasurer of California, Dr. Laura Li, founder and CEO of Breakthrough Genomics, as well as leaders and guests, including Mr. Liu Qiang, co-founder and COO of Singlera Genomics. Phoenix TV reported on the event. Singlera Genomics, as the technical support provider for Breakthrough Genomics, will use its pancreatic cancer liquid biopsy technology PDACatchTM to assist in serving a wide range of patients. PDACatchTM testing received breakthrough medical device certification from the U.S. Food and Drug Administration (FDA) in April of this year. PDACatchTM is a novel liquid biopsy detection technology based on DNA methylation, used for detecting pancreatic cancer in high-risk populations.

Breakthrough Genomics is now preparing to conduct large-scale clinical trials, offering PDACatchTM testing services to high-risk populations, including individuals with newly diagnosed diabetes, chronic pancreatitis, and other genetic risk factors. The company plans to provide this service through its CAP and CLIA-certified genomics laboratory in Irvine and offer it as a Laboratory Developed Test (LDT) to healthcare providers and their patients.

Minister Fiona Ma stated, "I am delighted to be here; our Southern California companies and scientific leaders are using world-class innovative technology to save lives." Dr. Laura Li, founder and CEO of Breakthrough Genomics, expressed, "So many people and their loved ones are affected by cancer, so we are honored to be part of this effort, continually improving this life-saving technology and providing this crucial testing service to those in need."

Singlera Genomics and Breakthrough Genomics had previously signed a strategic cooperation agreement in 2022 to jointly explore the U.S. cancer early screening market. In the future, Breakthrough Genomics will launch a series of products and services developed by Singlera Genomics to serve a wide range of patients in the United States. Mr. Liu Qiang, co-founder and COO of Singlera Genomics, stated, "As an important step in the company's internationalization strategy, Singlera Genomics will leverage its technological advantages, collaborate with partners, and bring more and better products and services to the world."

Singlera Genomics, in collaboration with Clinomics. Launching early cancer detection services.

🕒 April 28, 2023

Singlera Genomics announced a strategic cooperation agreement with Clinomics USA, a subsidiary of South Korean company Clinomics. Mr. Liu Qiang, co-founder and Chief Operating Officer of Singlera Genomics, attended the signing ceremony. This marks one of Singlera Genomics' significant steps in expanding its overseas market, demonstrating international recognition and favor for Singlera Genomics' technological capabilities in the global market.

After the signing of the agreement, the collaborating parties plan to establish a global strategic partnership for early cancer detection and diagnosis based on liquid biopsy. They intend to conduct business in early cancer detection and diagnosis based on blood globally. Both parties have reached an agreement to launch Singlera Genomics's independently developed ColonES® (colorectal cancer), PDACatch™ (pancreatic cancer), and PanSeer® (pan-cancer screening technology) testing services to the market. These services will be offered through Clinomics Irvine CLIA Lab located in the United States.

Mr. Liu Qiang expressed that the collaboration with Clinomics is a crucial step for Singlera Genomics in expanding its global market presence. Early cancer screening can effectively reduce the risk of illness, as well as the associated pain and economic burden, impacting the well-being of people worldwide. Singlera Genomics possesses advanced technology in the field of cancer early screening, and partnering with Clinomics will facilitate the efficient promotion and application of these technologies in relevant areas. This collaboration holds significant positive implications for Singlera Genomics, the early cancer screening industry, and people worldwide. In the future, Singlera Genomics will continue to deepen its involvement in this field, making every effort to keep people away from the suffering caused by cancer.

Clinomics (352770.KQ) is a South Korean biomedical innovation company dedicated to advancing the development and commercialization of liquid biopsy and multi-omics-based early cancer diagnostic technologies. In the first half of this year, they began introducing related early tumor detection products and expanded their presence to the United States, Europe, Japan, South Korea, and other Asian markets. According to the U.S. global market analysis firm GLOBE NEWSWIRE, as of 2022, the global early cancer diagnosis market is valued at $171.6 billion (approximately ¥1.213 trillion), with an annual growth rate of 8.6%. In order to provide services to the global market, Clinomics established subsidiaries in the United States and Hungary six years ago, setting up laboratories, human resource centers, and other infrastructure for clinical services related to early cancer diagnosis. They have also obtained relevant national/regional certifications for such services.