With FDA clearance of its Endoscreener that uses artificial intelligence (AI) to detect polyps during coloscopy procedures, Wision AI Ltd. is expanding its product portfolio to include colorectal histopathology tools.
The U.S. CMS has expanded the population of Medicare beneficiaries who are eligible for lung cancer screening via low-dose CT (LDCT) imaging. The news drew raves from stakeholders who also lauded the expansion of the facilities that can conduct the procedure, constituting a set of changes that advocates say will save thousands of additional lives.
Oncology genomic testing company Berry Oncology Corp.’s latest research results showed promising data for its Hifi platform-based technology, its CEO Jun Zhou said during the first International Biopharma Industry Week held in Shanghai. With the Hifi liquid biopsy test, users can receive early screening of six cancers, including liver cancer, lung cancer, gastric cancer, colorectal cancer, esophageal cancer, and pancreatic cancer, with an overall sensitivity of 87.6%, specificity of 99.1%, and overall tissue of origin precision in 82% of positive cancers.
Berry Oncology Corp. raised $99.15 million in a series B1 financing round to expand in the early cancer screening industry as it is seeing a growing demand in the sector. This brings the total capital raised to what it says is “the highest level in China’s early cancer screening industry.” The round was led by China Merchants Capital Management Co. Ltd., along with existing investors Qiming Venture Partners and Legend Capital.
A first-of-its-kind blood test that can detect whether cancer is absent, imminent, or present in different stages is on its way to the market. This is a claim made by brothers Ashish Tripathi and Anish Tripathi, who lead Singapore-based molecular diagnostic company Tzar Labs Pte. Ltd. and Mumbai-based Epigeneres Biotechnology Pvt. Ltd., respectively.
The U.S. Preventive Services Task Force (USPSTF) has updated its recommendations for lung cancer screening, which expands the age group for screening to include those aged 50-54 years. The change has forced CMS to reopen the national coverage memo for low-dose CT screening for lung cancer, which appears to be set to add millions to the number of Americans who are eligible for annual screening procedures.
The U.S. Centers for Medicare & Medicaid Services (CMS) has determined that the time has come to offer Medicare coverage for blood-based in vitro diagnostics as a screening tool for colorectal cancer (CRC), but there’s one catch: At present, there is no such test approved by the FDA that qualifies under the terms of the coverage memo, making this a null coverage proposition, at least for the time being.
HONG KONG – The third pre-revenue med-tech firm to list on the Hong Kong Stock Exchange in a month, New Horizon Health Technology Co. Ltd. raised HK$1.9 billion (US$245.08 million) in an IPO that began trading Thursday, Feb. 18. New Horizon placed 76.6 million shares at HK$26.66 apiece and said part of the funds will help the company commercialize its FIT-DNA test Coloclear to screen for colorectal cancer.
The draft version of the U.S. Medicare national coverage analysis for blood-based biomarker tests for colorectal cancer (CRC) engendered a large body of support, but several stakeholders recommended that the Centers for Medicare & Medicaid Services (CMS) avoid prescriptiveness regarding the sensitivity and specificity for any tests that would be covered under the policy.
Precision oncology company Genetron Holdings Ltd. will help develop a liquid biopsy-based malignant tumor screening and early detection testing kit based on its mutation capsule technology.
