SeekInClarity is a CE-IVD Mark, cost-effective, blood-based pan-cancer/pan-indication treatment response monitoring test that does not require cancer tissue analysis.
SeekInClarity test could identify a subgroup of patients as responders, who have better survival regardless of disease subtypes and stages, after the first or second cycles of treatment.
SHENZHEN, China, Nov. 7, 2022 /PRNewswire/ — SeekIn Inc, a leader in blood-based cancer early detection and monitoring technology, today announced the results of the pan-cancer/pan-indication treatment response monitoring test, SeekInClarity®, which were presented at the AMP 2022 Annual Meeting & Expo in Phoenix, Arizona, United States.
Imaging analysis is often used to assess disease burden and to evaluate treatment response for cancer patients. However, this relies on the presence of macroscopic tumor burden. Due to this limitation, patients can be incorrectly labeled as having complete remission even though minimal residual disease (MRD) may still be present. And the subsequent volume change of the tumor can take several cycles of treatments to be seen. In addition, techniques like PET-CT have relatively high costs and expose patients to radiation that can result in downstream negative health consequences. In order to improve upon our current ability to monitor cancer treatment response, the development of novel response assessment techniques is necessary.
“An accurate assessment of treatment response is essential to providing the best care for patients with cancer especially as the response rates of different cancer treatments range from 30% to 70%,” said Mao Mao, M.D., Ph.D., SeekIn’s founder and CEO. “Circulating tumor DNA (ctDNA) is a promising, noninvasive tumor biomarker that can aid in tumor monitoring throughout cancer care management. SeekInClarity®, a blood-based multi-omics assay, integrates the copy number aberration (CNA) index and the fragment size (FS) index of the cell-free DNA and seven protein tumor markers (PTMs) to quantify the molecular tumor burden (MTB) for monitoring cancer treatment response.”
A total of 114 patients meeting the WHO diagnosis criteria of lymphoid neoplasm were prospectively recruited from two clinical sites. Test performance was evaluated at multiple time points: before and after 1, 2, 4, and 6 cycles of treatment, thereinto samples from after one and two cycles of treatment were defined as landmarks. MTB status of each patient at each time point was calculated by integrating PTMs, CNA index and FS index through machine learning approaches.
At baseline, 73% of patients were MTB+. Progression-free survival (PFS) at baseline of MTB- patients was better than MTB+ patients. 36 out of 104 patients at landmark test were MRD+, who had a worse PFS time than those with MRD- status [HR: 8.5, 95% CI:2.6-27.4; P-value < 0.001]. Furthermore, patients with MRD- status had better PFS regardless of tumor stages and subtypes. The patients with MRD+ also had worse PFS than those with MRD- from the assessment after 1 cycle treatment [HR: 6.0, 95% CI:1.0-35.9; P-value=0.066], which demonstrated that compared with clinical imaging, SeekInClarity test could assess the response of treatment in advance, even after one cycle of treatment.
Further results showed that MTB dynamic change was also a good indicator of treatment response. 46 (60%) baseline MTB+ patients could achieve MRD- at landmark, which indicated the ctDNA and PTMs were cleared in blood and therefore the treatment was effective. Among patients with MTB positive at baseline, 6 patients with MTB increase had the worst PFS in the study.
“This study presents a strong demonstration that SeekInClarity can be considered an in vivo drug sensitivity test. Furthermore, high sensitivity and a significant lead time in monitoring treatment response before imaging can elicit a meaningful impact on patient outcomes by informing timely treatment decisions for personalized cancer management,” said Dr. Mao, “In addition, gaining the CE-IVD Mark for SeekInClarity test is an important milestone to make our test more accessible to patients around the world, contributing to helping more patients select the right treatments for their cancers, improve their quality of life and reduce health care costs.”
SeekIn Inc is a biotech company founded in early 2018 in Shenzhen, China, focusing on blood-based pan-cancer early detection utilizing next-generation sequencing and artificial intelligence. Since founded, SeekIn has been committed to providing cutting-edge and cost-effective solutions for cancer early detection, postoperative recurrence monitoring, and treatment response evaluation. SeekIn also developed novel molecular tests for leukemia patients. Its cancer early detection technology has been applied to canines as well. With its proprietary technical advances, SeekIn has launched a number of research and clinical studies in collaboration with top-tier hospitals in China. SeekIn envisions that by leading a new norm for cancer early detection the clinical outcome of mid-/late-stage cancer patients can be reversed and the cancer mortality rate can be reduced by 15%. For more information about SeekIn’s cutting-edge technologies and products, visit www.seekincancer.com.