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Agendia Presents Innovative FLEX Study Data at ASCO 2021 Demonstrating the Utility of MammaPrint and BluePrint in a Wide Variety of Patient Populations

Entire transcriptome evaluation of estrogen receptor optimistic (ER +) breast cancers didn’t present substantial variations in gene expression between tumors from girls youthful than 50 years and these from girls older than 50 years.

Entire transcriptome evaluation confirms that BluePrint ER + and ER- basal tumor genomic expression profiles are very comparable and present clinically actionable info to information neoadjuvant remedy choices.

10,000 sufferers with breast most cancers could have been enrolled in the FLEX world registry by the finish of 2021, and the final objective is for 30,000 to take action in whole.

Agendia, Inc., a world chief in precision breast most cancers oncology, introduced at the moment that new information from the nationwide FLEX registry, the first of its type, was introduced at the moment at the annual assembly of the American Society of Medical Oncology ( ASCO) of 2021.

The FLEX examine is led by US physicians and makes use of a shared examine infrastructure to develop and examine hypotheses for particular affected person subsets primarily based on complete transcriptome information, with observations of greater than 800 medical information gadgets. FLEX permits various teams of sufferers and their docs to take part in a medical trial, even when they don’t reside close to a massive analysis facility.

“FLEX has continued to show its worth in the large and rising array of information that’s accessible to oncologists and researchers,” says Cynthia X. Ma, FLEX doctor, oncologist, and principal investigator at Washington College Faculty of Medication in St. Louis. . “The collaborative nature of the registry gives clinicians the alternative to analyze the hypotheses raised in our real-world practices at the nationwide degree, to reply questions of medical significance and scientific curiosity. The depth and medical significance of our findings are felt all through the breast most cancers neighborhood. ‘

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At the ASCO 2021 digital convention, Agendia and its analysis companions introduced a normal replace on the FLEX trial, presently in the registration part, in a poster titled ‘Actual-world information platform FLEX explores new gene expression profiles and protocols pioneered by researchers in the early stage of breast most cancers».

FLEX’s skill to deal with pressing and related medical points was illustrated by information introduced on a poster titled ‘Entire transcriptome evaluation evaluating HR + HER2- breast most cancers tumors from sufferers youthful than and older than 50 years». The examine demonstrated that complete transcriptome evaluation didn’t establish substantial variations in gene expression between HR + / HER2- tumors in girls with breast most cancers, regardless of their age (older or youthful than 50 years). The info assist the possible rationalization that the obvious age-dependent profit of chemotherapy in girls beneath 50 with low-risk genomic most cancers, seen in latest trials, is just not on account of intrinsic organic variations in breast most cancers however slightly to variations in the oblique results of chemotherapy on the affected person. These findings reinforce the fundamental want for shared decision-making between the affected person and her doctor, utilizing the affected person’s genomic expression profile as half of an knowledgeable remedy plan.

“We’re very happy to current an age-based evaluation of genomics in early-stage breast most cancers, which has garnered a lot consideration in latest years,” mentioned Cathy Graham, MD, Surgeon, Director of Breast Surgical procedure at Glenn Household Breast Heart at the Winship Most cancers Institute at Emory Saint Joseph’s Hospital, and first creator of a FLEX poster specializing in age-based evaluation. ‘The rising pattern, which means that the profit of chemotherapy seen in youthful girls could also be a facet impact of ovarian suppression – not essentially the cytotoxic results of chemotherapy on a tumor – is once more seen in these outcomes and must be taken under consideration when doubtlessly much less aggressive alternate options can be found »

The FLEX researchers, together with Dr. Joyce O’Shaughnessy, Co-Chair of Breast Most cancers Analysis and Chair of Breast Most cancers Prevention Analysis at Baylor-Sammons Most cancers Heart and the United States Most cancers Community The USA, and a member of the Scientific Advisory Board of the United States Most cancers Analysis Community, introduced extra clinically related information for high-risk estrogen receptor-positive breast most cancers in a poster titled “Molecular profiles of ER + HER2- genomic high-risk breast most cancers tumors labeled as basal or luminal B, from the practical level of view, by the signature of 80 genes». This examine outlined the identification by BluePrint of a subgroup of high-risk ER + tumors which might be genomically basal, and discovered that evaluation of complete transcriptome expression profiles reveals that these cancers are biologically nearer to baseline ER (and most cancers). adverse breast) than ER + luminal. Subsequently, ER + basal tumors could require extra aggressive remedy than ER + luminal tumors, confirming that BluePrint supplies clinically actionable info past pathologic subtyping and can information neoadjuvant remedy choices.

One other examine from the FLEX database analyzed the correlation between a conventional pathological trait with poor prognosis, lymphovascular invasion (ILV), and gene expression patterns. The examine, entitled «Gene expression related to lymphovascular invasion and genomic danger in early-stage breast most cancers»Was launched by Nina D’Abreo, MD, Medical Director of the Breast Most cancers Program at Winthrop College Hospital, Perlmutter Most cancers Heart, and colleagues. With it they demonstrated that the potential diagnostic info obtained from the presence or absence of lymphovascular invasion (ILV) gene expression has most likely already been captured by MammaPrint and BluePrint. Considerably, the presence or absence of ILV in MammaPrint low-risk cancers was not related to any detectable distinction in complete transcriptome gene expression. At present, SIL is excluded from most medical danger assessments for breast most cancers and, though different research will assess medical outcomes, these information counsel that MammaPrint and BluePrint might fill the hole in the stratification of early stage breast cancers.

Agendia’s large-scale potential FLEX examine continues to offer a wealthy supply of real-world take a look at information in one of the most dynamic and inclusive examine designs in breast most cancers analysis to this point, underscoring the firm’s mission to assist information the analysis and customized remedy of breast most cancers for all sufferers.

About Agendia

Agendia is a precision oncology firm primarily based in Irvine, California, USA, dedicated to offering breast most cancers sufferers and their physicians with the info mandatory for higher decision-making all through their remedy. The corporate presently gives two commercially out there genomic profiling checks, supported by the highest ranges of medical and precise proof, that present complete genomic info that can be utilized to establish the only breast most cancers remedy doable for every affected person.

MammaPrint®, the 70-gene breast most cancers recurrence trial is the solely FDA-approved recurrence danger take a look at primarily based on potential peer-reviewed outcomes and the inclusion of nationwide and worldwide remedy pointers. BluePrint®, the 80-gene molecular subtyping assay, is the solely commercially out there take a look at that evaluates the underlying biology of a tumor to find out what makes it develop. Collectively, MammaPrint® and BluePrint® present a full genomic profile to assist clinicians make higher pre and postoperative remedy choices.

Agendia develops new evidence-based genomic checks and forges partnerships with revolutionary corporations to develop next-generation digital remedy instruments. Ongoing analysis creates an arsenal of information that improves affected person outcomes and helps the evolving medical wants of breast most cancers sufferers and their physicians each step of the approach, from preliminary analysis to most cancers elimination.

Agendia checks could be ordered on key biopsies or surgical specimens to facilitate pre- and postoperative remedy choices. For extra info on our ongoing trials and checks, go to

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Terri clevenger
Westwicke / ICR Healthcare PR
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