Latest Real World Evidence News

Orthocell has lodged a regulatory application to distribute its nerve repair product Remplir™ across the EU and UK, aiming to tap into a $750 million market with approval expected by Q3 2026.

Rhythm Biosciences has begun commercialising ColoSTAT®, its blood-based colorectal cancer diagnostic test, following an updated ISO15189, 2022 accreditation. The test offers a new option for symptomatic patients where stool-based screening is unsuitable.

OncoSil Medical’s interim OSPREY registry data reveals promising survival improvements for patients with unresectable locally advanced pancreatic cancer treated with OncoSil™ plus chemotherapy. The findings suggest a meaningful step forward in a field with limited effective options.

BCAL Diagnostics has secured national ethics approval to establish a large-scale registry tracking the clinical impact of its BREASTESTplus blood test for breast cancer diagnosis, aiming to enhance doctor adoption and reimbursement prospects.

Enlitic has expanded its collaboration with GE Healthcare, adding around US$1 million in revenue and broadening the use of its medical imaging data solutions. This move underscores growing trust and integration between the two companies.

Pacific Edge reports a $19.1 million net loss for the first half of FY26 amid Medicare coverage loss but positions itself for a Medicare-led recovery with strong clinical evidence and a key advisory committee meeting set for February 2026.

CSL Limited’s latest Capital Markets Day presentation highlights CSL Seqirus’s strategic positioning to capitalize on a recovering US influenza vaccine market and global growth opportunities.

4DMedical secures a major commercial breakthrough with Stanford University adopting its FDA-cleared CT, VQ™ technology, while its partnership with AstraZeneca rapidly scales lung screening across Brazil.

The European Medicines Agency has approved continuous bi-monthly dosing of CLINUVEL’s SCENESSE® for adult erythropoietic protoporphyria patients, removing previous annual dose limits and aligning Europe with US treatment standards.

Orthocell Limited reports an 81.1% overall treatment success rate from its Remplir Real World Evidence study, reinforcing the product’s safety and efficacy as it expands sales in the US and prepares regulatory submissions for the EU and UK.

Enlitic, Inc. has confirmed its commitment to achieving operational cashflow break-even by the end of 2025, alongside maintaining its revenue guidance of US$9-11 million for the calendar year.

BCAL Diagnostics has secured a strategic partnership with Cancer Care Associates to fast-track the clinical adoption and revenue generation of its innovative BREASTEST plus™ breast cancer blood test starting FY2026.