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Guardant health Initiates ORACLE analyze to consider performance of Guardant Revealtm Blood look at various to predict Recurrence across Early-Stage Cancers

categorised in: health, Science and technologySubject: Product/provider

Guardant health, Inc. (Nasdaq: GH), a leading precision oncology enterprise, has initiated the observation of ResiduAl melanoma with Liquid biopsy assessment (ORACLE) examine, a 1,000-patient prospective, observational, multi-core study designed to evaluate the efficiency of its Guardant Revealtm liquid biopsy test to foretell cancer recurrence after curative intent remedy, across 11 strong tumor kinds.

"For oncologists managing sufferers with early-stage cancer, there's a necessity for extra equipment to assist make informed selections related to chance for recurrence and advantage of adjuvant therapies, and steer clear of below- or over-medicine," mentioned Craig Eagle, MD, Guardant fitness Chief scientific Officer. "This examine is enjoyable since it will consider the first blood-simplest minimal residual ailment (MRD) assay in further tumor forms, and set the stage to establish alternatives for this expertise to increase patient care."

The examine will analyze circulating tumor (ctDNA) status from blood samples of patients with early-stage melanoma, using the Guardant demonstrate verify after the conclusion of medicine, and all through movements comply with-up. participants can be adopted until far-off recurrence, or up to 5 years. The ORACLE examine provides to currently underway clinical experiences (COBRA, ACT-three, PEGASUS) evaluating the performance of the Guardant display blood examine in patients with early-stage melanoma.

"Initiating this look at provides to the starting to be physique of facts in order to guide the expansion of the Guardant demonstrate blood verify from its first indication of early-stage colorectal cancer to distinct cancer types. We trust our blood-simplest verify will also be a magnificent and streamlined determination-making device for oncologists managing sufferers with early-stage cancers," referred to Helmy Eltoukhy, Guardant fitness Co-CEO. "The ORACLE examine exemplifies our commitment to further demonstrating the utility of our blood assessments to enrich lengthy-time period clinical results."

The Guardant display verify is the first blood-handiest liquid biopsy check that detects residual and recurrent disease from an easy blood draw. The verify detects ctDNA in blood after surgery, to determine sufferers with residual disorder who might also benefit most from adjuvant therapy, and to discover recurrence months sooner than current regular-of-care strategies.1-6 The commercially attainable examine achieves high sensitivity (ninety one%)7 for detecting ctDNA by way of concurrently interrogating each genomic modifications and methylation. the primary indication of the verify is colorectal cancer, with extra cancer forms to observe.

greater details in regards to the ORACLE examine can be found at NCT05059444.

About Guardant health

Guardant health is a leading precision oncology company focused on assisting overcome cancer globally via use of its proprietary exams, monstrous facts sets and advanced analytics. The Guardant health oncology platform leverages capabilities to drive business adoption, Excellerate patient scientific outcomes and lower healthcare charges across all tiers of the cancer care continuum. Guardant fitness has commercially launched Guardant360®, Guardant360 CDx, Guardant360 TissueNexttm, Guardant360 Responsetm, and GuardantOMNI® tests for superior stage cancer sufferers, and Guardant Revealtm for early-stage cancer patients. These tests gas construction of its LUNAR screening program, which aims to address the needs of asymptomatic people eligible for cancer screening.

ahead-looking Statements

This press release carries forward-searching statements within the which means of federal securities laws, together with statements involving the expertise utilities, values, merits and benefits of Guardant fitness's liquid biopsy checks or assays, which involve hazards and uncertainties that could trigger the genuine effects to vary materially from the predicted effects and expectations expressed in these forward-searching statements. These statements are in keeping with present expectations, forecasts and assumptions, and precise effects and results may differ materially from these statements due to a couple of components. These and additional risks and uncertainties that could have an effect on Guardant health's economic and operating results and trigger specific results to differ materially from these indicated by means of the forward-looking statements made in this press unlock consist of those mentioned under the captions "chance factors" and "management's dialogue and analysis of monetary condition and consequences of Operation" and elsewhere in its Annual record on kind 10-k for the yr ended December 31, 2020 and in its other studies filed with the Securities and trade fee, including its Quarterly file on kind 10-Q for the length ended March 31, 2021. The forward-searching statements in this press liberate are based on suggestions purchasable to Guardant fitness as of the date hereof, and Guardant health disclaims any duty to update any forward-looking statements offered to replicate any change in its expectations or any alternate in routine, situations, or cases on which the sort of observation is based, except as required by legislation. These ahead-searching statements may still not be relied upon as representing Guardant health's views as of any date subsequent to the date of this press unlock.

REFERENCES:

  • Reinert T, Henriksen tv, Christensen E, et al. analysis of Plasma mobilephone-Free DNA by Ultradeep Sequencing in patients With stages I to III Colorectal cancer. JAMA Oncology. 2019; 5 (eight): 1125-1131.
  • Tie J, Wang Y, Tomasetti C, Li L, Springer S, et al. Circulating tumor DNA analysis detects minimal residual ailment and predicts recurrence in patients with stage II colon cancer. Science Translational drugs. 2016; eight (346): 346ra92.
  • Tie J, Cohen J, Wang Y, et al. Circulating Tumor DNA Analyses as Markers of Recurrence risk and improvement of Adjuvant remedy for Stage III Colon melanoma. JAMA Oncology. 2019; 5(12): 1710-1717.
  • Peng J, Li Y, Mo S, Ma X, Hu X, Zhang L, et al. Prognostic value of circulating tumor DNA (ctDNA) detection during adjuvant chemotherapy in sufferers with stage III colorectal melanoma: The period in-between report of a potential, observational examine. Journal of scientific Oncology. 2020; 38, no.4_suppl.
  • Tarazona N, Gimeno-Valiente F, Gambardella V, et al. targeted subsequent-technology sequencing of circulating-tumor DNA for monitoring minimal residual disorder in localized colon cancer. Annals of Oncology. 2019; 30 (eleven): 1804-1812.
  • Reece M, Saluja H, Hollington P, Karapetis C, et al. the use of Circulating Tumor DNA to monitor and Predict Response to medication in Colorectal cancer. Frontiers in Genetics. 2019; 10: 1118.
  • Parikh A, Van Seventer E, Siravegna G, Hartwig A, et al. Minimal Residual disease Detection using a Plasma-handiest Circulating Tumor DNA Assay in Colorectal melanoma sufferers. medical cancer analysis. April, 2021; 10.1158/1078-0432.CCR-21-0410
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