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TRACERx MRD Results Showcase ppmSeq’s Ultra-Sensitive ctDNA Detection at AACR

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Minimal residual disease (MRD) continues to be a central focus at the AACR meeting. The small numbers of cancer cells that remain in the body after treatment helps gauge the effectiveness of a treatment and relapse risk. The ability to detect those cells, even in tiny amounts, is an ongoing goal of the cancer community.

At this year’s AACR, the sequencing company Ultima Genomics is announcing new findings in this area using its ppmSeq technology. The data will be presented across six abstracts, including a plenary session.

Highlighting the program will be initial TRACERx (TRAcking Cancer Evolution through therapy (Rx)) MRD data showcasing performance of ppmSeq relative to ultrasensitive bespoke panels.

TRACERx is a long-term study—one of the largest tumor evolution studies—funded by Cancer Research UK. The program analyzes how cancer evolves, spreads to other parts of the body, and develops resistance to treatments. Instead of taking just one biopsy, researchers sample different parts of the same tumor and metastases; the program involves sequencing multi-region and multi-time-point genetic data from over 3,200 tumor samples from over 800 lung cancer patients.

The data will be presented at a plenary session by Charles Swanton, FRCP, BSc, PhD,  professor at The Francis Crick Institute in the U.K. He will present an early validation pilot of ppmSeq across 50 plasma samples—using tumor-specific variants identified from prior whole genome sequencing—achieved high analytical sensitivity for ctDNA detection at low single-digit parts-per-million.

“TRACERx has always followed the science of cancer evolution wherever it leads,” said Swanton. “Improving the sensitivity of ctDNA detection is central to the wider ambition for MRD monitoring, and expanding studies across a broader patient population will give us the statistical power and clinical context to determine how whole genome MRD monitoring can be deployed at NHS scale and beyond.”

Data from collaborators will also be presented at the conference. Labcorp will present data from an independent analytical study of an assay developed in coordination with ppmSeq technology, including the performance across multiple solid tumor types in pre-surgical, treatment-naive plasma samples. This analysis of 120 non-cancerous donor samples showed specificity exceeding 99.9%, underscoring the ability of ppmSeq whole genome sequencing to accurately differentiate between cancerous and non-cancerous samples, minimizing false positives. Additional analysis across three commercially available cancer cell lines spanning 13 concentration levels from 0.5 to 500 parts per million showed a 95% limit of detection below 3 ppm, demonstrating the assay’s capacity to detect ultra-low levels of circulating tumor DNA (ctDNA).

“For a long time, the question has been whether you can get truly ultra-sensitive MRD detection from a whole genome approach without all the complexity of bespoke assays,” notes Gilad Almogy, PhD, CEO of Ultima Genomics. “What these AACR data show is that the answer is yes. We’re seeing ppmSeq deliver the level of sensitivity needed to make whole genome MRD practical, scalable, and much easier to deploy globally.”

The post TRACERx MRD Results Showcase ppmSeq’s Ultra-Sensitive ctDNA Detection at AACR appeared first on GEN – Genetic Engineering and Biotechnology News.

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STAT+: Up and down the ladder: The latest comings and goings

Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others. That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going.

And here is our regular feature in which we highlight a different person each week. This time around, we note that AstronauTx hired Michelle Mellion as chief medical officer. Previously, she held the same role at PepGen and EveryONE Medicines.

But all work and no play can make for a dull chief medical officer.

Continue to STAT+ to read the full story…

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Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others. That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going.

And here is our regular feature in which we highlight a different person each week. This time around, we note that AstronauTx hired Michelle Mellion as chief medical officer. Previously, she held the same role at PepGen and EveryONE Medicines.

But all work and no play can make for a dull chief medical officer.

Continue to STAT+ to read the full story…

Read More

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FDA imposes import alert on Indian plant after inspectors flag GMP failings

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Officials sanctioned Dabur India months after FDA inspectors found bird droppings and data integrity deficiencies during an inspection of the plant.

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STAT+: Pharmalittle: We’re reading about a discontinued cancer drug, a Novo security breach, and more

And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda includes promenading with the official mascots, catching another round of live musical vibes here and there, and taking pride in some folks who are dear to us. We also hope to hold yet another listening party, where the rotation will likely include this, this, this, this and this. And what about you? This is a wonderful time of year to sample the many outdoor activities popping up — street fairs, festivals, and all sorts of gatherings can be sampled. If the weather fails to cooperate, though, you could curl up with a good book, sit in front of the telly to take in one or more sporting events, or plan a needed getaway. If none of this strikes your fancy, you could simply park yourself somewhere comfortable for a while and remain zen. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon. …

In a rare move, the nonprofit organization Blood Cancer United announced it was buying the remaining supplies of Luvelta, a discontinued investigational cancer drug, STAT reports. As part of the transaction, Blood Cancer United, previously known as the Leukemia & Lymphoma Society, also will acquire the investigational new drug designation and manage the compassionate-use program for children with a rare form of blood cancer, distributing the medication to patients at no cost while supplies last. Sutro Biopharma discontinued development in March 2025 and also eliminated a compassionate use program.

Novo Nordisk identified a security incident in which certain information, ​including patient data from some clinical trials, was copied externally without ‌authorization from its internal IT systems, Reuters notes. The company said it launched a probe with the assistance of external ​cybersecurity experts and is in contact with the relevant authorities. The potential categories of ​personal data affected may include patient ID, year of birth, sex, and health or immunogenicity data among others. Novo did not provide further details, but does not ‌believe ⁠the incident will enable any third party to identify participants in its clinical trials.

Continue to STAT+ to read the full story…

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And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda includes promenading with the official mascots, catching another round of live musical vibes here and there, and taking pride in some folks who are dear to us. We also hope to hold yet another listening party, where the rotation will likely include this, this, this, this and this. And what about you? This is a wonderful time of year to sample the many outdoor activities popping up — street fairs, festivals, and all sorts of gatherings can be sampled. If the weather fails to cooperate, though, you could curl up with a good book, sit in front of the telly to take in one or more sporting events, or plan a needed getaway. If none of this strikes your fancy, you could simply park yourself somewhere comfortable for a while and remain zen. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon. …

In a rare move, the nonprofit organization Blood Cancer United announced it was buying the remaining supplies of Luvelta, a discontinued investigational cancer drug, STAT reports. As part of the transaction, Blood Cancer United, previously known as the Leukemia & Lymphoma Society, also will acquire the investigational new drug designation and manage the compassionate-use program for children with a rare form of blood cancer, distributing the medication to patients at no cost while supplies last. Sutro Biopharma discontinued development in March 2025 and also eliminated a compassionate use program.

Novo Nordisk identified a security incident in which certain information, ​including patient data from some clinical trials, was copied externally without ‌authorization from its internal IT systems, Reuters notes. The company said it launched a probe with the assistance of external ​cybersecurity experts and is in contact with the relevant authorities. The potential categories of ​personal data affected may include patient ID, year of birth, sex, and health or immunogenicity data among others. Novo did not provide further details, but does not ‌believe ⁠the incident will enable any third party to identify participants in its clinical trials.

Continue to STAT+ to read the full story…

Read More

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