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Diagnostics World | Even though roughly two-thirds of pivotal studies leading to FDA drug approvals now enroll women at rates aligned with their disease burden, their inclusion has “plateaued." Diagnostic criteria and disease models remain largely male-centered because they don’t take into account of the biological and hormonal rhythms that shape women’s health across their lives. That diagnostic blind spot reverberates throughout drug development.
Nov 12, 2025
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Diagnostics World | Veterans of Illumina and Grail launched Hepta, a biotechnology company using transformer-based AI to read the cell-free DNA (cfDNA) epigenome and detect organ-specific signals of chronic disease. Hepta emerged from stealth with $6.7 million in seed funding.
Nov 11, 2025
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Diagnostics World | For most physicians, concerns about artificial intelligence (AI) continue to outweigh enthusiasm for its potential to improve healthcare decision-making and patient outcomes. Doctors need to understand the reasons behind the predictions of AI tools if they’re expected to use the insights as a starting point for discussing treatment options with their patients.
Nov 6, 2025
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Diagnostics World | NHS England is trialing a 15-minute blood test that can distinguish between bacterial or viral infections, identifying serious diseases like sepsis or meningitis quickly in children.
Nov 4, 2025
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Diagnostics World | When patients are prescribed drugs with a narrow therapeutic window, where the difference between an effective and toxic dose can be frighteningly small, therapeutic drug monitoring is crucial to their safety. Outside of a hospital setting with expensive lab equipment and specialized staff to do the monitoring, things can get dicey.
Oct 30, 2025
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Diagnostics World | Pangaea launches its next-generation platform; EpiSign launches its Methylation-based Episignature Testing and Reference-based Interpretation & Classification (METRIC); Biodesix signs an expanded partnership agreement with Bio-Rad Laboratories; and more.
Oct 29, 2025
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Diagnostics World | Kailera Therapeutics advances their obesity portfolio; Trogenix combines cancer cell killing and immune stimulation, delivered via a Trojan Horse approach that reawakens the immune system; and more.
Oct 28, 2025
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Diagnostics World | Modern healthcare algorithms are trained with large volumes of data and can recognize patterns and correlate them with outcomes. However, there is still the issue of bias against underrepresented groups, even though these algorithms are trained using diverse populations. Researchers from the Icahn School of Medicine at Mount Sinai have developed AEquity, a tool of identification that reduces biases in datasets used to train machine learning algorithms.
Oct 24, 2025
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Diagnostics World | Earlier this month, MyHeritage announced that they have upgraded their at-home DNA tests to have Whole Genome Sequencing. By utilizing Ultima Genomics’ sequencing technology and processing at the Gene by Gene lab, MyHeritage is the first major commercial DNA testing company to adopt Whole Genome Sequencing at such a massive scale of over one million tests per year.
Oct 22, 2025