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.

Pattern Computer Inc.'s test for SARS-CoV-2 infection gives new meaning to rapid results. Taking 15 seconds from start to result, the test offers balanced accuracy of better than 96%, according to the company. The test is also not dependent on timing, unlike current antibody tests, and takes less time than point-of-care PCR tests. Its light-based system creates patterns based on a saliva sample, which is then matched against a previously developed model.

Princeton University spinout Neutigers Inc. is launching a study to explore the use of artificial intelligence (AI) and everyday wearables to flag early symptoms of sickle cell anemia vaso-occlusive crisis (VOC) before they get worse and land patients in the hospital. The aim is to reduce deaths and facilitate interventions to address the entire continuum of care for patients with the inherited red blood cell disorder, Adel Laoui, founder and CEO, told BioWorld.

LONDON – New data from a randomized community study involving more than half a million people has shown that of 92,116 who had symptomatic COVID-19, 38% were still reporting symptoms 12 weeks later.

Adela snapped up $60 million in a series A financing round to commercialize its blood test for cancer detection and disease monitoring. At the same time, the company announced its name change from Dnamx Inc. The Adela system profiles all methylated DNA fragments in a blood sample, allowing it to determine the tissue of origin early in development of a malignancy and potentially simplifying screening across all cancer types.