SeqOne’s New Clinically Validated HRD Test Reduces Number of Inconclusive Results to Improve the Prescription of Targeted Treatments for Ovarian Cancer Patients

• The Homologous Recombination Deficiency (HRD) biomarker identifies ovarian cancer patients likely to respond to PARP-inhibitors.
• SeqOne’s test simplifies the deployment of this test while reducing the number of inconclusive results, even when biopsies have low tumoral content.
• Test accuracy was validated with the PAOLA-1 reference cohort and is presented at ESMO-GYNAE Barcelona on the 24th of February, 2023

BARCELONA, Spain & MONTPELLIER, France–(BUSINESS WIRE)–SeqOne, provider of new generation genomic analysis solutions for personalized medicine, is announcing at the ESMO GYNAE conference a new HRD test that renders Homologous Recombination Deficiency (HRD) testing more accessible to Ovarian cancer patients. HRD status is key in the prescription of PARP inhibitor Olaparib, that improves survival of HRD positive patients.

SeqOne’s approach simplifies the deployment of this test so that it can be performed by any well equipped lab. To do this, SeqOne has based its test on a combination of two easily performed genomic analyses, a targeted gene panel and a low-pass whole genome, that together give excellent results when compared with reference tests. The test has also been validated on multiple sequencers and reagents. These results were clinically validated through a retrospective analysis of the PAOLA-1 cohort that was initially used to demonstrate the efficacy of Olaparib for HRD-positive patients. The cohort remains the gold standard for clinically validating all subsequent HRD tests.

Another key focus was to ensure that actionable results could be obtained even with biopsies of low sample quality (low tumoral content), as this has proved to be a major obstacle to delivering usable results in clinical routine environments. SeqOne was able to deliver actionable HRD scores using samples of lower quality than most other tests; as little as 20% of cellularity and 50 nanograms of genetic material.

“One of ARCAGY-GINECO ’s missions is to allow the validation of HRD testing through clinical evaluation on the PAOLA-1 cohort and to offer the medical professionals a reliable and objective assessment of test performance “. Said Pr. Pujade Lauraine, Medical Director of ARCAGY-GINECO. “SeqOne approached us early on in order to validate their test and have delivered a solution that is easy to implement and delivers great performance. I am glad that the clinical evaluation of their test is being presented today by my colleague Romain Boidot at ESMO GYNAE in Barcelona.”.

“Our objective was to deliver an easy to use test that would work even with samples of low tumoral content while affording medical professionals the assurance of test quality through a recognised certification process” said Nicolas Philippe, CEO of SeqOne. “I am proud that we have delivered on this objective”.

“As a user of SeqOne’s solution, we are pleased with the ease-of-use, accuracy and its tolerance to samples of low-tumoral content” said Marie-Pierre Wissler, a pathologist working at Cypath. “It means we can return an HRD status more often than we could with previous vendors while at the same time reducing turnaround time.”

Clinical evaluation of SeqOne HRD is presented at ESMO GYNAE, in Barcelona on Feb 24th 2023, by Romain Boidot, molecular biologist at the Centre Régional de Lutte contre le Cancer Georges François Leclerc (CGFL) Dijon

The SeqOne HRD score was validated using a retrospective analysis on 364 ovarian cancer patients from the PAOLA-1 phase 3 clinical trial. There is the same survival benefit for HRD+ patients when being treated with olaparib plus bevacizumab compared to bevacizumab alone, regardless of whether SeqOne HRD or Myriad myChoice® CDx test was used to form the HRD subgroup. In addition, SeqOne HRD has a smaller rate of inconclusive results compared to the inconclusive rate obtained with Myriad myChoice® CDx. Additional analyses to evaluate the HRD biomarker have been conducted: (i) a replication analysis on 48 individuals to test the reproducibility of the BRCA variant calling approach and (ii) a comparison of HRD testing using either NovaSeq and NextSeq sequencers to perform sWGS. Both analyses confirm the robustness of the SeqOne test.

To know more about SeqOne HRD test and solutions : https://www.seqone.com/

Contacts

SeqOne media contacts
Annie-Florence Loyer – [email protected] / +33 (6) 88 20 35 59

Jean-Marc Holder – [email protected] / +33 (6) 03 24 57 56