NEW YORK – Singapore-based genomic medicine startup Lucence Diagnostics plans to enter the US cancer market by building a laboratory in Silicon Valley and subsequently launching its LiquidHallmark late-stage lung cancer treatment selection next-generation sequencing assay in the second half of 2020.
The firm also presented the results of a validation study earlier this month, applying the error-correction sequencing amplicon-based platform in hematological cancers.
Originally spun out of Singapore's Agency for Science, Technology, and Research in 2016 by CEO Min-Han Tan, Lucence developed AmpliMark to identify appropriate treatments for cancer and viruses by noninvasively detecting specific markers of treatment sensitivity. The firm raised $9.2 million in seed funding in Aug. 2017 and later established an office in San Francisco in April 2019. In November, the firm raised $20 million in a Series A funding round to expand access to its technology to more patients in Asia and North America.
According to Tan, the firm's blood-based platform combines molecular barcoding and its artificial intelligence-powered SunTzu.AI clinical analytics engine to target clinically relevant genomic alterations, including somatic mutations, single nucleotide variants, microsatellite instability, and fusion errors.
The LiquidHallmark assay requires about two tubes of 10 ml from a cancer patient, and according to Tan, the amplicon-based NGS process only requires "a matter of days" to produce actionable results for clinicians caring for lung cancer patients.
In the internal validation study, Lucence researchers assessed the firm's HemeMark primer-based target capture panel — which analyzes 45 genes and 6 microsatellite loci — on blood samples from 65 patients with hematological malignancies, including acute myeloid leukemia, myelodysplastic syndromes, and multiple myeloma. The team also tested matched DNA from bone marrow and peripheral blood samples from 14 patients in the cohort.
They found that the AmpliMark technology successfully detected specific mutations at a sensitivity down to 0.1 percent variant allelic frequencies (VAF) and fusions genes down to 1 percent VAF.
"To my knowledge, this is the among the largest cohort of matched bone marrow and blood testing," Tan highlighted. "The data that we provided is one of the largest datasets for fully matched blood and bone marrow results that strongly supports the use of highly sensitive methods for blood [circulating tumor DNA] monitoring in hematological disorders."
Tan acknowledged that the main limitation with amplicon-based sequencing is determining the breadth of the panels in terms of gene selection. However, the firm believes that developing an assay with fewer but clinically actionable mutations can provide more advantages compared to larger gene panels for diagnosis and monitoring.
"For clinical-use panel designs, the most important technical feature is the [tech's] sensitivity [and ability] … to detect a relatively narrow number of established clinically actionable markers," Tan explained. "Because of its fundamental chemistry, we believe that amplicons, which depends on amplicon sequencing, lends the technology a significant part of its sensitivity."
While the internal study applied AmpliMark to hematological cancers, Lucence will initially push into the US market by applying the LiquidHallmark assay for late-stage lung cancer treatment selection. The firm expects to complete building a CLIA-certified, CAP-accredited lab in Silicon Valley by Q3 of the year.
"Our primary interest is bringing our technology to our lab, as we're already a US [CLIA-certified, CAP-accredited] lab in Singapore," Tan said. "The LiquidHallmark assay will be offered to [US] customers for both clinical and research uses after [achieving] suitable licensing and accreditation."
Tan said Lucence will develop evidence for its AmpliMark technology in the US by working closely with payors, clinicians, and other partners. The firm also plans to secure reimbursement through performing health economic analyses and supporting clinical utility studies, and is interested in analyzing biomarkers for immunotherapy response.
In addition to lung cancer, Tan highlighted that Lucence will investigate other types of cancers, including breast and hematological cancers.
Noting that there are already "low-toxicity approaches to initially detecting breast cancer," Tan envisions, instead, using the AmpliMark technology for breast cancer patient monitoring and relapse. For hematological cancers, however, Lucence seeks to apply the technology at multiple timepoints, including initial detection and monitoring due to the tool's high sensitivity.
Because clinicians often aggressively treat patients with hematological cancers to cure them, Tan said that accurate diagnosis and monitoring patient relapse are critical to overall treatment.
"Demonstrating that noninvasive AmpliMark-based blood assays can achieve equivalent disease profiling to invasive procedures like bone marrow biopsy can, therefore, mean better patient outcomes by enhanced monitoring with fewer invasive approaches … which is a primary goal of ours," Tan explained.
While Lucence has filed IP methods of sensitive cancer signal detection in the US and internationally, Tan declined to note the total number of patents in the firm's portfolio.
"Our AmpliMark technology allows for quicker and more sensitive detection of cancer mutations in blood," Tan explained. "We have optimized an amplicon-based approach to rapidly amplify cancer signals from patient plasma for accurate variant detection, as compared to capture-based technology."