diagnostics Archives - Medical Design Sourcing

Brain breakthroughs: Aprinoia Therapeutics’ harnesses AI and strategic partnerships to propel neurodegenerative disease research

Neurodegenerative disease research is witnessing significant advances. To that end, Hong Kong-headquartered Aprinoia Therapeutics is embracing a ‘precision neuroscience’ approach to neurodegeneration diagnostics. The company’s lead program, APN-1607, represents a new generation of advanced tau positron emission tomography (PET) tracers, which play a crucial role in effective and efficient diagnosis of patients suffering from neurodegenerative disorders.

Aprinoia Therapeutics’ strategy to neurodegenerative disease research focuses in part on artificial intelligence (AI) and forging strategic collaborations. Paul Tempest, the head of medicinal chemistry at Aprinoia, leads a team of experts in the field of neuroscience, AI, and pharmaceutical development. In a recent interview, Tempest explained how this multifaceted approach supports innovation in the development of novel diagnostic tools and therapies for neurodegenerative diseases.

AI in dr…

FDA will review fewer COVID-19 test EUA submissions

The FDA has granted emergency use authorization for more than 430 COVID-19 tests. [Photo courtesy of Mayo Clinic]

The FDA is pushing COVID-19 test developers away from emergency use authorization (EUA) submissions in favor of more traditional pathways, the agency said today.

The FDA said it intends to review “only a small subset” of new EUA submissions, encouraging test makers to seek regulatory approval through de novo classification or 510(k) clearance pre-market review pathways.

The policy update comes a week after the U.S. Department of Health and Human Services Office of Inspector General released a study that found the FDA’s EUA process authorized problematic tests and frustrated diagnostics developers.

The FDA’s “calculated decisions to increase availability of COVID-19 testing … often came at a potential cost to test quality,” the report said. R…

Startup licenses Harvard tech to develop ultra-sensitive COVID antibody assay

This colorized scanning electron microscope image shows SARS-CoV-2 (round blue objects), the virus that causes COVID-19, emerging from the surface of cells cultured in the lab. [Image courtesy of National Institute of Allergy and Infectious Diseases]

New startup Spear Bio plans to commercialize ultrasensitive protein-detection technology from Harvard University’s Wyss Institute for Biologically Inspired Engineering.

Boston-based Spear Bio licensed the DNA nanotechnology-driven Successive Proximity Extension Amplification Reaction (SPEAR) in a worldwide exclusive agreement with Harvard’s Office of Technology Development.

Spear Bio will develop a reagent-based platform for ultrasensitive protein detection in small-volume samples with an initial focus on research-use-only applications, Harvard said in a news release.

RELATED: Here’s where Harvard’s engineering dean sees medtech research going Read more

Roche to donate more medicines and diagnostics to Ukraine

With the war in Ukraine on the verge of entering its second month, Roche (SIX:RO, ROG; OTCQX:RHHBY) has announced that it will donate additional medications and diagnostics to the country.

The company had announced its plans to aid the country in early March, which included 150,000 packs of the antibiotic Rocephin, an antibiotic WHO lists as an essential medicine.

Roche will donate an additional 4,600 packs of medicines for influenza, rheumatoid arthritis, spinal muscle atrophy and some cancers. Additionally, the company will provide reagents and consumables to support testing 120,000 blood donations and 31,000 units for diabetes management.

In addition to providing supplies to Ukraine, several pharma countries, including Lilly, GSK and Pfizer, have announced plans to curtail operations or realign their business focus in Russia.

Are predictive diagnostics the Doppler radar of disease?

Image courtesy of Wikipedia

What do cupcakes have to do with oncology, and more specifically, predictive diagnostics?

Before I explain, I’ll provide some context. I recently came across an image that illustrated the difference between how Doppler radar detects conditions for a Tornado Watch versus a Tornado Warning using cupcakes.1 One side of the graphic shows each of the ingredients measured in individual containers. This visual represents when you have everything you need to make a cupcake; in weather terms, the conditions are favorable for a cupcake. A cupcake watch could be declared, but no fully-baked, devourable cupcake is visible yet. On the other side of the image, once the ingredients are assembled and baked, it’s much clearer that we have an actual cupcake on our hands and, therefore, a warning would be in place. For meteorologists, this is when Doppler radar has detected a full tornado, com…