June 20, 2023, Exact
Sciences, an international leading company for early cancer screening, announced that its clinical trial code-named BLUE-C has been completed and the results of the trial have been announced. Compared with the previous generation, the new generation of Cologuard has significantly improved the specificity, reaching 91%, and the sensitivity has increased from 92% to 94%, among which the sensitivity of precancerous lesions has increased by 1 percentage point, reaching 43%. This means that the new generation of Cologuard has higher accuracy and reliability in the early detection of colorectal cancer and precancerous lesions, surpassing the previous generation of products in an all-round way.
Based on this result, Exact Sciences plans to submit a marketing application for its next-generation Cologuard to the U.S. Food and Drug Administration (FDA) by the end of 2023.
It is worth noting that the BLUE-C clinical trial also collected blood samples in preparation for subsequent evaluation of blood-based colorectal cancer detection methods.The move signals Exact Sciences’ plans to develop a blood sample-based method for early screening of colorectal cancer, into the field of blood testing. This has increased competitive pressure for companies such as rival Guardant Health, as the blood test has significant potential and market opportunity in colorectal cancer screening.
It is not difficult to see from the above that the sensitivity of CRC early cancer and precancerous lesions is the most important clinical value index, and blood testing has become a key field for many companies to compete. These trends and results will have a major impact on the field of early screening and diagnosis of colorectal cancer.
Early detection of colorectal cancer (CRC) and precancerous lesions (AA) plays an important role in reducing the mortality of colorectal cancer. Precancerous lesions are reversible changes that precede the initiation of development on the inner surface of the colorectum, which can gradually develop into cancer. Early CRC and AA are often asymptomatic, so early detection by trusted screening methods is key.
As a key method for CRC screening, blood testing plays an important role in this field. Traditional CRC screening methods include colonoscopy, fecal occult blood test, etc., but these methods have problems such as low sensitivity and compliance. For example, colonoscopy requires a long time and professional technical operations, which may lead to unwillingness or delay of some people for screening. However, the fecal occult blood test has limited ability to detect precancerous lesions, and there is a certain risk of misdiagnosis and missed diagnosis, which further reduces its reliability and compliance. Blood sample collection is relatively convenient and does not require invasive examinations such as colonoscopy, so it has wider applicability and acceptance, and can indirectly evaluate the presence of colorectal cancer or precancerous lesions by detecting specific markers in the blood.
In addition to Exact Sciences, the domestic Zhongjing Pukang also recently announced exciting news. The company’s self-developed Precogify Advanced Colorectal Neoplasia Screening test (PrecogColo Dx?
test) based on serum metabolism detection for early screening of colorectal cancer and advanced adenoma, has obtained the breakthrough medical device certification from the US Food and Drug Administration (FDA), proving its innovation in the field of early diagnosis of colorectal cancer Sexuality and leadership, reflecting the leading position in blood testing methods in the field of CRC and AA.
test (Zaochangjing?) is the first blood test product launched by Zhongjing Pukang for early detection of colorectal cancer. The detection method is based on serum metabolism detection and has obtained international and domestic patents.According to clinical trial data, Zaochangjing? has further improved the sensitivity of precancerous lesions compared with the data disclosed by Blue-C. In the early stage of colorectal cancer data, the sensitivity and specificity of Zaochangjing? are comparable to the data performance of Blue-C, far higher than those of Freenome and Guardant
Data released by Health at the same time. Therefore, the clinical detection performance of Zaochangjing is at the leading level in the world, and it has become the first self-developed multi-omics blood detection product for early colorectal tumors in China.
Obtaining FDA breakthrough medical device certification is an important milestone for Zhongjing Pukang. The FDA’s Breakthrough Devices Program is an approval process for medical devices that more effectively treat or diagnose life-threatening diseases. “Breakthrough Devices
The Program aims to increase patient access to innovative, safer new treatments and diagnostics by expediting the development and review process and increasing access to treatment for patients with life-threatening and irreversible diseases of aging.
Dr. Dai Xudong, the founder of Zhongjing Pukang, said that the sensitivity and specificity of Zaochangjing® are significantly better than Septin 9 blood test and Cologuard test based on stool DNA in advanced adenoma and early colorectal cancer stage. Therefore, the acquisition of this certification marks an important starting point for Zhongjing Pukang to base itself on domestic clinical practice and move towards the global market strategy. He also emphasized that Zhongjing Pukang will carry out international cooperation based on the core AI causal discovery platform and rapid mass spectrometry kit conversion technology platform to accelerate product development and commercialization.
The breakthroughs of these two companies will bring new possibilities and opportunities to the field of early screening of colorectal cancer. With the continuous development of early tumor detection technology, patients will be able to detect and treat colorectal cancer earlier, thereby improving survival rate and quality of life. In addition, this will also prompt other competitors to accelerate the pace of innovation to meet the demand for more accurate, non-invasive early screening methods. With more innovations and breakthroughs, it is believed that there will be more exciting news and progress in the field of early screening of colorectal cancer, which will bring good news to the cause of human health.