March 28, 2018 | March featured news, products, and partnerships from around the diagnostics community from numerous companies, universities, and organizations, including Caris Life Sciences, Quanterix, Intezyne, and more.
Caris Life Sciences announced publication of an article that demonstrated the company's proprietary ADAPT Biotargeting System (ADAPT) significantly out-performed standard HER2 testing in predicting response to trastuzumab (Herceptin) for breast cancer patients. The study, entitled "Polyligand Profiling Differentiates Trastuzumab-Treated Breast Cancer Patients According to Their Outcomes," was published in Nature Communications [DOI: 10.1038/s41467-018-03631-z]. "Although current companion diagnostics have made a positive impact in cancer care, much more can be done. For example, the response rate for vemurafenib in melanoma with a V600E mutation is only about 50%. Similarly, the response rate for olaparib for BRCA-positive ovarian cancer is less than 35%," said David D. Halbert, Chairman and CEO of Caris Life Sciences, in a press release. "We know we can do better and this study proves that our proprietary technology can be utilized to develop dramatically superior companion diagnostic tests for existing and emerging therapeutics. The ADAPT Biotargeting System is providing unrivaled molecular insights and is primed to up-end conventional profiling as the new standard of molecular profiling for the future." Press Release
Quanterix announced a collaboration with DestiNA Genomics, a manufacturer of patented reagents for nucleic acid detection. Both companies are pioneering microRNA detection and this collaboration brings together high-specificity and ultra-sensitivity for the first time, enhancing RNA biomarker detection. The collaboration’s initial efforts are focusing on the development of a nucleic acid assay for direct detection and quantification of the liver toxicity biomarker microRNA-122, which is shown to have earlier and more specific performance than current protein biomarker assays. DestiNA’s breakthrough proprietary ‘Stabiltech’ buffer allows the direct quantification of microRNAs to single base resolution without isolation from serum or plasma. This proprietary capability also enables the shipment and storage of samples prior to analysis at room temperatures, eliminating the need for refrigeration, promising better work flows and more reliable results. The combination of Quanterix’ SR-X Ultra-Sensitive Biomarker Detection System and DestiNA’s proprietary chemistry gives researchers access to a PCR-free approach that delivers a simpler, faster preparation and analysis time, as well as high accuracy. The ability to detect microRNA from serum and plasma without PCR creates significant opportunities for the development of microRNA as valuable clinical biomarkers, particularly in the pharmaceutical, animal health and crop protection sectors. DestiNA has also purchased the SR-X for its Research and Development Center in the Science Park of Granada, Spain, and is poised to become the first company in Europe to offer novel circulating RNA-based assays. Among new assays planned are those based on detection of exosomal RNA such as ALK variants, and a range of simplified, robust RNA-based assays. Press Release
Quanterix also announced its industry-leading single molecule array, or Simoa, technology has achieved enhanced sensitivity for the detection of acute HIV infection relative to currently approved fourth-generation antigen-antibody (Ag/Ab) combination (combo) and stand-alone p24 assays. The study, conducted by EQAPOL, Duke Human Vaccine Institute and Center for HIV / AIDS, and Blood Systems Research Institute (BSRI), was presented as a poster session this week at the Conference on Retroviruses and Opportunistic Infections (CROI) in Boston, MA. Led by BSRI in collaboration with several other research institutions and biotechnology companies, the study used a series of blinded panels of serial dilutions containing genetically and geographically diverse HIV clinical isolates to assess the sensitivity (p24 Ag relative to viral loads) of HIV clinical diagnostic, blood screening, and next generation p24 Ag assays. Findings illustrate similar performance across subtypes between current FDA-approved techniques and stand-alone p24 Ag immunoassays. Additionally, the study demonstrated that newer generation pre-clinical p24 Ag detection platforms, such as Simoa, achieved significantly heightened sensitivity for detection of the clinical isolates as compared to existing immunoassay methods. Specifically, results demonstrate that Simoa was able to detect 99% of the diluted viral samples across diverse subtypes that had been characterized by nucleic acid testing (NAT), the gold standard for sensitive virus detection. In comparison, FDA-approved immunoassay methods detected only 30-40% of the samples. These results suggest the potential for a simple immunoassay blood test to provide NAT-level sensitivity for acute HIV detection. Such a test could significantly enhance the ability to detect the infection while in the acute phase when it is most infectious. While NAT is the gold standard for sensitivity, it is more complex and costly to deploy relative to immunoassays. Deployment of a simple immunoassay with NAT sensitivity, especially in lower resource settings, could positively affect HIV epidemiology though wider access to more sensitive detection of early infection. Press Release
Intezyne announced that it has partnered with Exosome Diagnostics to design and validate an assay for use in Intezyne's upcoming Phase 1/2 clinical trials of IT-139, a novel Cancer Resistance Pathway (CRP) inhibitor for the treatment of pancreatic, gastric and other cancers in combination with existing anti-cancer therapies. "In order to optimize further clinical development of our novel Cancer Resistance Pathway (CRP) inhibitor, IT-139, we need a biomarker to stratify patients into potential responders and non-responders," said E. Russell McAllister, CEO of Intezyne, in a press release. "After evaluating a number of potential partners and technologies, we selected Exosome to design and validate a GRP78 assay using their proprietary exosomal RNA platform technology." "We are excited to leverage our patented ExoLution isolation kit, a cGMP-grade exosome RNA isolation platform, that provides increased sensitivity to develop a companion diagnostic for IT-139," stated John Boyce, President and CEO for Exosome Diagnostics, in a written announcement. "Exploiting a novel mechanism of action, Intezyne's IT-139 has demonstrated remarkable potential to mitigate pan-cancer drug resistance. We are thrilled to utilize our leading expertise in the liquid biopsy field, potentially enabling such a promising therapeutic breakthrough." Press Release
Cernostics announced that it has raised $2.5 million in Series A1 financing, led by Illumina Ventures. With this capital investment, Cernostics will be able to intensify its clinical and market development studies for the company’s TissueCypher Barrett’s Esophagus Assay — the first test of its kind to predict risk of development of esophageal cancer in patients with Barrett’s esophagus. Barrett’s esophagus, which affects more than three million Americans, occurs when chronic exposure to acid from the stomach causes the esophageal cell lining to deteriorate, creating an environment for cancer. Without treatment, Barrett’s can lead to esophageal adenocarcinoma, the fastest-rising cancer in the US Today, the most common approach to managing Barrett’s is surveillance, involving regular endoscopic procedures with biopsy, monitoring for disease progression, and GERD-related drug therapy to control symptoms and prevent injury to the esophagus. Traditional management of Barrett’s esophagus has left gaps in the diagnosis and grading of the disease. While early detection makes esophageal cancer preventable, both endoscopists and pathologists face challenges in determining which patients are truly at risk for progression of the disease. Cernostics’ TissueCypher Barrett’s Esophagus Assay was specifically designed to address these challenges by linking test performance to clinical outcome or progression to cancer, not level of dysplasia. By validating TissueCypher against progression to cancer, the test helps to mitigate challenges associated with sampling error and subjective diagnosis of histology grade. Press Release