SAN FRANCISCO--()--Sequenta, Inc. today announced the publication in the journal BLOOD of two landmark studies involving more than 150 patients that demonstrate the company’s LymphoSIGHT™ next generation sequencing method is more sensitive than existing tools for detecting minimal residual disease (MRD). These studies provide clinical validation for the use of the LymphoSIGHT™ platform in the treatment of B cell acute lymphoblastic leukemia (ALL); the most common childhood cancer.
“Ongoing studies in this and other lymphoid cancers will establish our technology as the clinical standard in lymphoid cancer MRD testing.”
One study, which was published today in the online version of BLOOD, showed that the LymphoSIGHT™ method detected MRD in patient samples that originally tested negative by flow cytometry and polymerase chain reaction (PCR). A separate study, published in BLOOD in August, showed that the LymphoSIGHT™ platform can track clonal evolution of disease cells in pediatric samples at unprecedented levels. The early detection of MRD has important implications for the treatment of ALL. Increasing the sensitivity of MRD detection in the face of disease heterogeneity is critical to improving care.
“MRD is the most important prognostic biomarker that allows the adjustment of treatment necessary to achieve cures and save children’s lives,” said Dr. Dario Campana who led the collaboration with St. Jude Children’s Research Hospital. “Sensitive universal methods such as this that give us the earliest possible detection of MRD will lead to the best chance for cure.”
The LymphoSIGHT™ platform leverages the power of next generation sequencing to detect individual B cells at levels as low as one cell per million white blood cells using a universal reagent set and patient blood samples.
“These studies provide a foundation for the clinical utility of the LymphoSIGHT™ platform for monitoring previously undetectable residual disease in leukemia,” said Sequenta Chief Scientific Officer and senior study author Dr. Malek Faham. “Ongoing studies in this and other lymphoid cancers will establish our technology as the clinical standard in lymphoid cancer MRD testing.”
In the newly published study, performed in collaboration with the St. Jude Children’s Research Hospital, researchers compared the LymphoSIGHT™ method with the gold standard MRD assays currently used by the medical community: multiparameter flow cytometry and allele specific oligonucleotide PCR (ASO-PCR). Diagnostic and follow-up samples from 106 patient samples, with and without detectable MRD, were evaluated using high throughput sequencing. The LymphoSIGHT™ method confirmed the presence of MRD in samples considered positive by flow cytometry and ASO-PCR and also revealed MRD in ten samples that were negative by flow cytometry (ten percent of the total) and three samples that were negative by ASO-PCR.
In a parallel study, conducted with Stanford University and published online (before print) on August 28 in BLOOD, the LymphoSIGHT™ method was used to characterize the extent of genetic evolution present in diagnostic samples from 51 children with B precursor acute lymphoblastic leukemia (B-ALL). The genetic evolution of cancer is known to be a factor in the development of drug resistance and relapse. Researchers used the LymphoSIGHT™ method to comprehensively analyze hundreds of thousands of cancer cells, describing for the first time ongoing and extensive clonal evolution at the IgH locus. Many of the undetected clones were present at concentrations below the level of detection of standard diagnostic methods.
“The level of clonal evolution was very unexpected and may reveal an important prognostic factor that has not been able to be measured using other methods,” said Dr. Gary Dahl, with the Stanford University School of Medicine, Department of Pediatrics, Division of Hematology- Oncology-Stem Cell Transplantation and Cancer Biology. “This capability will become increasingly important as the clinical significance becomes better studied.”
Sequenta’s first commercial test, ClonoSIGHTTM, will enable physicians to utilize this same MRD detection technology as a clinical decision-making tool in their own practices and will be available for purchase in 2013.
About Sequenta, Inc.
Sequenta is a venture backed startup dedicated to improving patient care in diseases mediated by immune cells through measurements of lymphocyte diversity. It is commercializing its LymphoSIGHT™ platform for clinical use in minimal residual disease while continuing to validate the use of its technology in a diverse set of diseases. For more information, go to www.sequentainc.com.