Latest In Vitro Diagnostics News

Atomo Diagnostics has signed an MOU with Innovation Scientific to develop a fourth-generation HIV rapid test using its Galileo cassette. The project could add a new product to Atomo’s pipeline, but regulatory approval, clinical work and definitive commercial agreements remain outstanding.

Biotron has appointed Glenn Gilbert as chief executive and executive director, bringing more than two decades of pharmaceutical, medical device and diagnostics experience to the company’s SedRx and antiviral programs. His package combines a $250,000 salary with up to 100 million performance-based options and $230,000 in milestone-linked cash bonuses.

Pacific Edge is positioning Cxbladder for a Medicare-led recovery, but the company remains loss-making with NZ$7.8 million in net cash after a difficult FY26. The investment case now turns on final US coverage, test volumes and whether the enlarged balance sheet can carry the business to scale.

Pacific Edge’s draft Medicare Local Coverage Determination for its Cxbladder bladder cancer tests marks a pivotal step toward unlocking a $10.2 billion global market. Despite FY26 setbacks, the company is poised for growth with improved reimbursement prospects and strategic cost management.

INOVIQ Ltd has revealed significant sample quality problems in its EXO-OC ovarian cancer diagnostic study, prompting a technical review and a refined development approach while maintaining its dual commercialisation strategy.

INOVIQ Limited hit a roadblock in expanding clinical validation of its EXO-OC™ ovarian cancer test due to unsuitable biobank samples, yet improved its diagnostic algorithm and progressed its CAR-exosome therapeutic program, maintaining a solid cash position of A$9.35 million.

BCAL Diagnostics has acquired a 10.2% stake in Genetic Signatures for $1.39 million, aiming to merge early cancer detection with infectious disease diagnostics and expand its international footprint.

Pacific Edge reported a $35.8 million loss in FY26 amid a 47% revenue drop following Medicare coverage loss, but a draft Medicare policy and $36.1 million capital raise set the stage for recovery.

Nexsen Limited has cleared a major FDA regulatory hurdle for its StrepSure rapid Group B Streptococcus test, confirmed a clear 510(k) submission pathway, and secured over A$1.7 million in non-dilutive grants to expand clinical validation and market rollout in Asia-Pacific and neonatal diagnostics.

A new clinical study from Sichuan University confirms that TruScreen’s AI-enabled cervical cancer screening combined with high-risk HPV testing outperforms traditional cytology methods, reinforcing its global potential.

AnteoTech has raised A$3.5 million through a discounted share placement to accelerate commercialisation of its advanced battery and life sciences technologies globally. The capital injection supports strategic partnerships and sales expansion in key markets including the US and India.

Atomo Diagnostics has locked in exclusive global rights to a novel liver function test that rapidly detects liver injury, expanding its footprint in point-of-care diagnostics. The test, delivered on Atomo’s Pascal platform, targets drug-induced liver injury and chronic liver conditions with significant commercial potential.