COMPANY:

Lucence

"Lucence announced its receipt of confirmation that Medicare coverage for its LiquidHALLMARK® liquid biopsy test applies for patients with all stages of advanced solid tumors. This confirmation marks a significant milestone in promoting access to personalized oncology care on a broader scale."

"Lucence announced that interim results for LIQUIK, a prospective international multicenter liquid biopsy study for lung cancer, will be reported at the IASLC 2023 World Conference on Lung Cancer (WCLC) on September 9-12, 2023...Key objectives are prospective comparisons of Lucence’s LiquidHALLMARK® amplicon-based assay to tissue-based next generation sequencing (NGS), as well as to an FDA-approved circulating tumor DNA (ctDNA) liquid biopsy test."

"The American Medical Association (AMA) has granted a Current Procedural Terminology (CPT) Proprietary Laboratory Analyses (PLA) code for our LiquidHALLMARK™ liquid biopsy test. The CPT PLA code uniquely identifies the LiquidHALLMARK™ test for payors and providers, thus reducing administrative burdens and improving access."

"Lucence...announced...a strategic collaboration with Innovent Biologics, Inc. to improve access of Hong Kong patients with advanced bile duct cancer (cholangiocarcinoma) to the FDA-approved targeted treatment Pemazyre® (pemigatinib)...Under the agreement, Innovent will sponsor Lucence’s LiquidMARK™ Bile Duct test for Hong Kong patients with a diagnosis of bile duct cancer who fulfil criteria."

"Lucence will present promising new data on earlier cancer detection based on AmpliMark, its amplicon-based next generation sequencing technology at the 59th Annual ASCO Meeting in Chicago, June 2-6, 2023."

"Lucence unveiled LucenceINSIGHT™, its pioneering multi-cancer early detection (MCED) blood test, at their US headquarters...Lucence is launching LucenceINSIGHT™, an MCED test first internationally and with a follow-up U.S. launch in Q3 2023. This ctDNA-based liquid biopsy test screens for 10 common cancers in one blood draw."

"...Lucence has secured approval for its Singapore-invented cancer tests from Medicare, a US government-funded healthcare insurance programme primarily for people aged 65 years and older...The programme covers about 64 million people in the US and will reimburse patients for using Lucence’s blood test, LiquidHallmark, to detect lung cancer. In the US, there are about 150,000 new cases a year of advanced lung cancer in patients aged 65 and above."

"Lucence announced...that Palmetto GBA, a Medicare administrative contractor and leader in evaluating molecular diagnostic technology through its laboratory technology assessment group for the Molecular Diagnostics Services program (MolDX), has finalized a foundational Local Coverage Determination (LCD) for the LiquidHALLMARK assay. The LCD covers all nine NCCN guideline-recommended molecular biomarkers in advanced lung cancer patients using LiquidHALLMARK."

"Lucence...is sharing promising interim results from the prospective multicenter validation study of its LiquidHALLMARK ctDNA liquid biopsy assay for the detection of guideline-recommended biomarkers in metastatic lung cancer. Results from the study— LIQUIK, or Liquid Biopsy for Detection of Actionable Genomic Biomarkers in Patients with Advanced Non-small Cell Lung Cancer—were shared as part of a poster presentation at the 4th Annual Congress of the International Society of Liquid Biopsy in Miami, Florida."

"Precision oncology firm Lucence said Tuesday that it has entered a new partnership with laboratory diagnostics distributor Omnigen Medical Products to expand access to its liquid biopsy tests for cancer patients in Turkey...Under the terms of the agreement, Omnigen will market tests, including Lucence's LiquidHallmark next-generation sequencing assay, to Turkish hospitals and clinicians as part of its existing business as a distributor of genetic testing and molecular and pathological equipment."

"Precision oncology company Lucence...has entered into a research collaboration with the National Cancer Centre Singapore to evaluate the company's LiquidHallmark assay for improving prostate cancer treatment in Asian men...The collaborators plan to conduct a prospective study to better define the clinical utility of LiquidHallmark in guiding treatment decisions and achieving therapy outcomes among men with metastatic castration-resistant prostate cancer."

"Researchers from A*STAR’s Institute of Bioengineering and Bioimaging (IBB), in collaboration with Changi General Hospital (CGH) and Lucence...conducted the first local prospective study which demonstrated that a blood-based liquid biopsy can be used to complement the conventional tissue biopsy for lung cancer diagnosis...The study focuses on non-small cell lung cancer (NSCLC) and has shown that a liquid biopsy test could be used to extract relevant information for a preliminary diagnosis."

"Lucence will present new data at the upcoming IASLC 2022 World Conference on Lung Cancer on August 6-9, 2022, highlighting novel applications of its ultrasensitive amplicon-based next generation sequencing technology in the detection and treatment of lungLucence recently announced the publication of a validation study for its flagship LiquidHALLMARK ctDNA Liquid Biopsy Assay. The study, published in PLOS ONE, establishes LiquidHALLMARK’s performance and identifies actionable biomarkers in 70% of lung cancer patients. In addition to showing high sensitivity of both LiquidHALLMARK and Lucence’s AmpliMark amplicon next-generation sequencing (NGS) platform, external validation with cobas® EGFR Mutation Test v2 for lung cancer specimens demonstrated an overall concordance of 84.00% with a 100% concordance rate for EGFR variants above 0.4% VAF. cancer."

"In plasma samples from non-small cell lung cancer (NSCLC) patients that were either baseline driver-negative (by ctDNA) or treated with tyrosine kinase-inhibitors, the combined assay found 8.7% (9/103) more actionable fusions than ctDNA alone. Together ctRNA and ctDNA resulted in detection of 30 fusions compared to 21 when only ctDNA was tested, representing a 42.8% (9/21) increase in fusion-specific detection of the combined assay; additional fusions detected included BRAF, MET and NRG1 fusions."

"Lucence, the precision oncology company pioneering ultrasensitive liquid biopsy tests, is announcing the recent publication of a study validating its LiquidHALLMARK ctDNA liquid biopsy assay in PLOS ONE, a peer-reviewed, open access scientific journal. The study results establish high sensitivity, specificity, accuracy and precision of LiquidHALLMARK, based on the AmpliMark amplicon-sequencing platform, and support compelling clinical applications for its use."

"Lucence...is announcing the availability of an expanded version of its flagship LiquidHALLMARK liquid biopsy assay that includes both cell-free DNA (cfDNA) and cell-free RNA (cfRNA) profiling. LiquidHALLMARK cfDNA and cfRNA is currently available to US oncologists as a laboratory developed test and is being utilized by physicians at NCI-designated centers across the country."

"In partnership with the VA Palo Alto Health Care System, precision oncology company Lucence is launching its first early detection study in the United States evaluating the use of its liquid biopsy technology in a screening context. The study, led by Rajesh Shah, MD, of the VA Palo Alto Healthcare System and Stanford University, will test the feasibility of using non-invasive liquid biopsy in patients at high-risk for lung cancer as a screening tool in combination with positron emission tomography–computed tomography (PET/CT)."

"Lucence and the VA Palo Alto Health Care System are launching a prospective observational study to evaluate the use of the sequencing-based LiquidHallmark liquid biopsy assay in a screening context...The study will compare the sensitivity and specificity of positron emission tomography-computed tomography (PET/CT) alone versus PET/CT in combination with LiquidHallmark in detecting lung cancer nodules between six and 20 millimeters in size, among high-risk patients with at least one lung nodule suspected of malignancy."

"AstraZeneca Singapore and Lucence announced today that they have entered into an agreement to provide improved access to Homologous Recombination Deficiency (HRD) testing for newly-diagnosed advanced ovarian cancer patients in the South-East Asia (SEA) region...This partnership with Lucence accentuates AstraZeneca’s ongoing push to tap into the expertise of healthcare innovators to help those suffering from chronic conditions such as diabetes, heart disease and cancer."