Given the advances being made in cancer treatments, it’s time to move beyond the maximum tolerated dose (MTD) to dose-optimization trials for targeted therapies, the U.S. FDA said in a new draft guidance.
Act Genomics (Hong Kong) Ltd. won U.S. FDA approval for its genomic profiling test for solid tumors, Actonco. This marks the first time an Asia-based company has received FDA clearance for a comprehensive genomic profiling test.
The U.S. FDA has granted Datar Cancer Genetics Inc. a breakthrough device designation for Trinetra-Glio, a blood test to help in the diagnosis of brain tumors.
The new year kicked off with good news from the U.S. FDA for Onconano Medicine Inc. The agency granted the company’s pH-sensitive fluorescent nanoprobe, pegsitacianine, breakthrough therapy designation for use as an adjunct for visualization of metastases in the peritoneal cavity.
Engineers from Washington University in Saint Louis are developing a novel imaging technique for evaluating the use of alpha-particle emitting radiopharmaceutical therapy in tumors and other radiation-sensitive organs of the body. They have tested a low-count quantitative single-photon emission computed tomography (LC-QSPECT) method to provide reliable measurements of the radionuclide uptake in lesions and at-risk organs after its administration.
Burning Rock Biotech Ltd.’s share price flared up on Tuesday morning on news of U.S. FDA breakthrough device designation for its Overc multi-cancer detection blood test (MCDBT). The stock closed on Dec. 30, 2022, at $2.26 and rose sharply on the announcement to open at $2.89. By the end of the day, however, the stock had sunk to $2.15.
Bertis Co. Ltd.’s artificial intelligence (AI)-based diagnosis model is able to detect diseases, such as cancers, with more than 95% accuracy, according to preliminary testing results reported at the Human Proteome Organization 2022 meeting in Cancun, Mexico on Dec. 8.
Transition ultrasound startup QT Imaging Inc. is poised to go public via a merger with Gigcapital5 Inc., a special purpose acquisition company (SPAC), in a deal that puts the equity value of the combination at $151 million. The combined company, QT Imaging Holdings Inc. will be traded on the NYSE under the ticker symbol QTI.
Avenda Health Inc. secured FDA 510(k) clearance for its Iquest platform, which uses artificial intelligence to map the location of a tumor within the prostate. The visualization created provides better assessment of the extent of the malignancy and improves selection of treatments. Avenda raised $10 million in August to support development of Iquest, which guides the company’s Focalpoint laser ablation system.
Pancreatic cancer is the deadliest of cancers with just one in nine patients surviving five years after diagnosis. The low rate of survival largely results from the late stage at which the cancer is first detected, as 65% patients are not diagnosed until the disease has metastasized. Bluestar Genomics Inc. hopes it has developed an assay that can detect the cancer much sooner, allowing patients and their physicians to get ahead of the malignancy well before it spreads.
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