Women with endometriosis may soon be able to have a simple blood test to diagnose their disease thanks to a breakthrough by Proteomics International Ltd. that has developed a plasma protein biomarker panel that identifies all stages of endometriosis.

The question of how skin pigmentation affects the performance of pulse oximeters has drawn the U.S. FDA’s close attention for several years, and the agency issued a draft guidance to address these questions. The draft guidance recommends that new and existing devices be evaluated to establish performance across different pigmentations, a development that would address concerns among clinicians and patients alike.

Artificial intelligence (AI)-based models developed by a team of international researchers were able to identify ovarian cancer in ultrasound images more accurately than humans. Results from a study published in Nature Medicine showed that the AI models achieved an accuracy rate of 86.3%, compared to 82.6% for the experts and 77.7% for the non-expert examiners.

For more than a decade, HIV remained the only sexually transmitted infection (STI) with U.S. FDA approval of at-home sample collection, but a growing number of tests for sexually transmitted infections have received the regulatory greenlight for patients to swab themselves in the privacy of their own homes in recent years. With STIs reaching levels not seen in decades, regulators and physicians hope that the move will increase diagnostic rates and reduce disease spread by overcoming stigma and access barriers.

AI-powered drug R&D platform firm Oncocross Co. Ltd. is leading the procession of year-end Korea biotech IPOs this week, pricing an offering of about 11.85 million shares on the Korea Exchange at ₩7,300 each for gross proceeds of ₩85.56 billion (US$59.5 million).

South Korea’s Ministry of Food and Drug Safety cleared Acryl Inc.’s Acryl-D01 as the country’s first AI-based digital therapeutic software solution to aid depression screening and diagnosis on Dec. 20. Approved as a class II software as a medical device, Acryl-D01 utilizes a patient’s medical records to quantify and analyze the individual’s emotional response and assess the probability of having clinical depression based on the data.

A new method to diagnose skin cancer was validated for the first time in clinical trials that show Dermr Health Solutions Pty Ltd.’s non-invasive microneedle patch collects near-equivalent genetic information compared to a skin biopsy without pain or cutting.

In a recently published study, researchers from the University of Pennsylvania and collaborators aimed to identify compounds with high affinity to α-synuclein aggregates and high selectivity toward pathological α-synuclein compared to other brain targets.

AI-powered drug R&D platform firm Oncocross Co. Ltd. is leading the procession of year-end Korea biotech IPOs this week, pricing an offering of about 11.85 million shares on the Korea Exchange at ₩7,300 each for gross proceeds of ₩85.56 billion (US$59.5 million).

Labcorp Holdings Inc. launched its new H5N1 bird flu molecular test for humans in the U.S. as an international outbreak of the disease continues to spread in cows and poultry – and people. As BioWorld reported recently, just one mutation would make the flu variant highly transmissible in humans.