The FDA has given a green light to Foundation Medicine Inc.’s Foundationone CDx as a companion diagnostic for Takeda Pharmaceutical Co. Ltd.’s Alunbrig to identify patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small-cell lung cancer (NSCLC). The approval comes as Laboratory Corp. of America Holdings (Labcorp) is launching a companion diagnostic to identify NSCLC patients with the KRAS mutation. NSCLC accounts for about 85% of all lung cancers, with an estimated 1.8 million new cases diagnosed each year worldwide. Of those, 3% to 5% carry the ALK gene mutation, which is often missed with standard testing methods.
PERTH, Australia – With FDA approval of its Guardian system to detect early heart attacks, Angel Medical Systems Inc. (Angelmed) will launch the device in the next six weeks in the U.S., and partner Hydrix Ltd. will launch the devices in eight Asia Pacific markets.
Looking to allow customers to directly purchase its diagnostics system that runs a full panel of blood tests, Babson Diagnostics Inc. raised $31 million in new series B financing. The proceeds will be used to scale the Austin, Texas-based company to bring its finger-prick blood microsampling system to retail locations across the country.
An artificial intelligence (AI)-powered tool invented by researchers from a trio of Singaporean institutions could speed up the diagnosis of cardiovascular diseases. The innovation uses electrocardiograms (ECGs) to diagnose coronary artery disease, myocardial infarction and congestive heart failure.
As the first flagship action of Europe’s plan to beat cancer, the European Commission launched its Cancer Knowledge Center June 30. The new online platform will map the latest evidence on cancer, provide health care guidelines and quality assurance schemes, and monitor and project trends in cancer incidence and mortality across the EU, where cancer is the No. 1 killer for people younger than 65.
PERTH, Australia – Cyclopharm Ltd. said it received a complete response letter (CRL) from the FDA for its Technegas NDA for pulmonary embolisms. The CRL relates to better defining and validating production and delivery of the Technegas particle and other aspects of crucible manufacturing and dosimetry that need to be addressed before the NDA can be approved.
Mfb Fertility Inc. received CE mark approval for its Proov PdG tests, giving European women direct access to information about ovulation without a prescription. The test enables a woman to test her urine for production of sufficient progesterone to confirm ovulation and favorable conditions for conception.
PERTH, Australia – Cyclopharm Ltd. said it received a complete response letter (CRL) from the FDA for its Technegas NDA for pulmonary embolisms. The CRL relates to better defining and validating production and delivery of the Technegas particle and other aspects of crucible manufacturing and dosimetry that need to be addressed before the NDA can be approved.
The U.S. Senate and the House of Representatives have reintroduced the Verifying Leading-edge IVCT Development (VALID) Act, a bill that would authorize the FDA to regulate lab-developed tests (LDT). The question of the agency’s statutory authority to regulate LDTs is part of a long-running debate, but the immediate question is whether Congress will see fit to deal with the question this year rather than wait until 2022, when the next device user fee will require legislative authorization.
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