SAN FRANCISCO--(BUSINESS WIRE)--Sequenta, Inc. and their collaborators presented data from four new clinical studies in which the LymphoSIGHT™ method demonstrated superior sensitivity in measuring minimal residual disease (MRD) in bone marrow and peripheral blood from acute lymphoblastic leukemia (ALL) patients. The presentations were made at the 2012 American Society of Hematology (ASH) annual meeting in Atlanta this week.
“These and other ongoing studies make our ClonoSIGHT™ assay the only clinically validated sequencing approach to immune cell monitoring.”
Combined with two studies previously published in BLOOD, a total of six clinical studies have firmly established the value of the LymphoSIGHT™ method for MRD assessment in adult and pediatric ALL patients and demonstrated more comprehensive MRD coverage compared to flow cytometric and allele-specific oligonucleotide polymerase chain reaction (ASO-PCR) methods.
LymphoSIGHT™ is the core technology that serves as the basis for Sequenta’s commercial product, ClonoSIGHT™.
“The studies presented at ASH, representing more than 300 ALL patient samples, form the basis of a strong clinical validation of our approach to MRD testing,” said Sequenta CEO Tom Willis. “These and other ongoing studies make our ClonoSIGHT™ assay the only clinically validated sequencing approach to immune cell monitoring.”
The LymphoSIGHT™ method utilizes a proprietary assay for the amplification and sequencing of immunoglobulin and T cell receptors, demonstrating:
- Increased sensitivity (ability to detect cancer at levels of one cell per million white blood cells)
- Increased coverage of all patients (more than 95 percent calibration rate at diagnosis)
- Universal and scalable assay yielding robust data
In addition, the platform has revealed underappreciated disease heterogeneity. The platform’s ability to measure the full spectrum of genetically related cancer cells promises to be important in the future.
“The value of MRD in making treatment decisions in ALL is now well established,” said David Miklos, M.D., Ph.D., Assistant Professor of Medicine at Stanford University. “Sequenta’s approach represents the future of MRD testing, allowing clinicians to monitor all disease clones in virtually all patients even when they are present at very low levels.”
ClonoSIGHT™, a Sequenta product that uses the LymphoSIGHT™ method, has now been implemented in Sequenta’s CLIA accredited lab. This test offers deep clonality assessment of blood and marrow samples across multiple immune receptors in a clinical setting and has a seven day turnaround time from blood collection to results.
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.