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MX3 Diagnostics, Illumina, QIAGEN, And More: News From June 2019

July 1, 2019 | June featured news, products, and partnerships from around the diagnostics community from numerous companies, universities, and organizations, including MX3 Diagnostics, Illumina, QIAGEN, and more.

MX3 Diagnostics announced the pre-order availability of its flagship portable product, the MX3 Hydration Testing System Pro Version. The system uses a handheld digital meter and app to measure and track personal hydration levels. It is the world’s first point-of-care system using saliva to provide immediate and accurate diagnostic tests for health and fitness. By using saliva—easily accessible and incredibly informative—the MX3 device will let users measure key indicators of health and well being without expensive, invasive lab equipment. This innovative approach eliminates the need for blood prick or urine tests, with results uploaded seamlessly to a mobile device and stored in the cloud, allowing users to manage and track their personal hydration levels anywhere at any time. "MX3's proprietary system for rapid saliva testing has been proven in multiple studies to be as effective as FDA-approved equipment found in traditional labs," said Michael Luther, co-founder and CEO of MX3 Diagnostics, in a press release. "We made our first test for hydration because it is so important for health and fitness, but really hard for athletes to reliably assess. What’s exciting about saliva is that it is non-invasive and able to measure not just hydration but other markers related to energy levels, work load and recovery, diet and nutrition, sleep and stress, and more." MX3 is emerging from stealth mode to disrupt the multibillion dollar health monitoring device market with US headquarters in Austin, Texas and offices in Minneapolis, Minnesota and Melbourne, Australia. The company has developed patent-pending technology that enables lab-quality health diagnostics without the complications and costs of a physical lab. Press release

Illumina announced the launch of VeriSeq NIPT Solution v2, a CE-IVD, next-generation sequencing (NGS)-based approach to noninvasive prenatal testing (NIPT). The automated comprehensive solution allows laboratories to screen for a broader range of chromosomal and sub-chromosomal conditions associated with birth defects and adverse pregnancy outcomes than the standard NIPT menu. VeriSeq NIPT Solution v2 delivers the most comprehensive view of the fetal genome compared to other CE-IVD NIPT products, enabling healthcare providers to support expectant parents with informed, timely and personalized pregnancy management options better than ever before. VeriSeq NIPT Solution v2 is now available across most countries in Europe, as well as South Africa. Product registration is pending in Australia, Israel and New Zealand. VeriSeq NIPT Solution v2 provides accurate information about fetal chromosomal status as early as 10 weeks of gestation using a single maternal blood draw. This noninvasive test provides an option to screen for aneuploidy in all autosomes, chromosomes X & Y, and partial deletions and duplications greater than 7 Mb across the genome. Due to its high-sensitivity and high-specificity (low false-positive and false-negative rates), NGS-based NIPT minimizes the need for invasive testing procedures. The automated, reliable solution provides reagents, instruments, installation and training, and offers unprecedented turnaround times; laboratories can process up to 96 samples in approximately one day. Press release

QIAGEN and DiaSorin announced the expansion of their QuantiFERON collaboration to develop an ultra-sensitive diagnostic test for Lyme disease, which is expected to address a significant unmet medical need. The companies plan multi-site clinical validations during the 2020 Lyme disease season, with regulatory submissions expected at the end of the same year in the United States and Europe. The QuantiFERON technology comes in two components: the QuantiFERON sample collection component with the proprietary assay stimulus/initiation and QuantiFERON read-out component to measure the signal created by the stimulus. The QuantiFERON read-out component of the assay will be run on DiaSorin's widely used LIAISON family of fully automated analyzers and both components will be designed for use on these platforms. Press release

Caris Life Sciences announced that it has entered into a strategic collaboration with Debiopharm for the development of a companion diagnostic (CDx) test using its newly-launched Whole Transcriptome Sequencing (WTS) assay for mRNA analysis called MI Transcriptome. The assay, which was granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) in early May, reliably detects rare fibroblast growth factor receptor (FGFR1, FGFR2 and FGFR3) fusion events.

"This agreement supports our vision for optimizing the detection of rare fusion events using RNA, and building value on our multi-platform tumor profiling approach," W. Michael Korn, Chief Medical Officer at Caris Life Sciences, said in a press release. "We continue to develop novel technologies to provide the most comprehensive molecular profiling possible." Under this agreement, MI Transcriptome will be used to identify eligible patients for Debiopharm's FUZE Phase II Pivotal Trial of Debio 1347, a selective FGFR inhibitor that Debiopharm is evaluating for the treatment of patients with non-central nervous system solid tumors that have a specific FGFR gene fusion. Debio 1347 received Fast Track designation from FDA earlier this year. In addition to developing MI Transcriptome CDx, Caris will use its MI Trials service to improve the identification of patients eligible to enroll in the FUZE trial, analyzing the tens of thousands of patients profiled by Caris Life Sciences each year. The FUZE study is an open-label, blinded, multicenter, pan-cancer international Phase II Basket Trial that plans to enroll 125 patients across more than 20 countries. Press release

Proscia released DermAI, the first in its series of AI applications that advance the practice of pathology. A module on Proscia's Concentriq platform, DermAI leverages deep learning to pre-screen and classify skin biopsies to help reduce costly errors and improve laboratory quality and efficiency as the number of medical professionals entering the field of pathology continues to decline. The standard of care for diagnosing the 25 million skin biopsies taken in the US every year has been based on a pathologist’s interpretation of patterns in tissue using a microscope. This 150-year-old manual and subjective practice cannot keep pace with the increasing demand for pathology diagnosis or deliver critical data in the promise of precision treatment. Proscia’s DermAI uses deep learning to read and automatically classify hundreds of variants of skin diseases into pre-diagnostic categories to improve the confidence, quality, and speed of pathology. Proscia trained and tested the DermAI algorithm using patient biopsies from leading academic and commercial derm laboratories including Cockerell Dermatopathology, Dermatopathology Laboratory of Central States, University of Florida, and Thomas Jefferson University Hospital. This multi-site study successfully validated the performance of DermAI using over 20,000 patient biopsy slides. Proscia intends to submit DermAI to the FDA for review to use in clinical diagnosis. Press release

A new study in Experimental Physiology proposes a novel, non-invasive test for assessing gut function that may help screen and monitor treatment of gut diseases using only a small sample (1 mL) of blood and stool. How well your gut functions is determined by the gut-blood barrier, a complex multi-layer system. This can be compared to a fine-tuned filter that precisely controls the passage of nutrients and prevents bacteria passing from inside the bowel into the bloodstream. In those with inflammatory bowel disease (IBD), and other intestinal diseases, the gut-blood barrier is impaired. Here the intestinal wall is more like a ripped sieve, allowing more bacterial products to pass from the gut into the blood. This is commonly referred to as a leaky gut. This test measures the concentration of gut bacterial products (produced by bacteria during metabolism) in the patient's blood and stool. The authors believe that with further research this assessment of gut leakage will be very important in the diagnosis and treatment of IBD and other intestinal diseases. This new research provides a non-invasive, simple test that could not only be useful for diagnosing IBD, but also other gut disorders, such as celiac disease and food allergies. It's also helpful for detecting diseases that result in a leaky gut, such as heart failure, high blood pressure and liver ailments. Press release

Thrive launched with $110 million in a Series A financing. Thrive will further advance and commercialize CancerSEEK, a liquid biopsy test designed to detect multiple cancer types at earlier stages of disease. CancerSEEK has been developed by cancer research pioneers Drs. Bert Vogelstein, Kenneth Kinzler and Nickolas Papadopoulos at Johns Hopkins University. CancerSEEK combines analysis of a highly targeted set of DNA and protein measurements from blood to detect cancer, demonstrating greater than 99% specificity in a retrospective study published in Science. Minimizing the "false-positive" results common in today's early cancer screening tools enables physicians to focus follow-up procedures on patients who truly have cancer and for whom the doctor can take treatment action. Thrive plans to integrate real-world data and machine learning to continue to improve CancerSEEK over time and to create a cost-effective comprehensive care solution for primary care physicians. "Over the past 30 years we have made great strides in understanding cancer. Combining this knowledge with the latest in molecular testing technologies, our founders have developed a simple and affordable blood test for the detection of many cancers at relatively early stages," said Christoph Lengauer, partner at Third Rock Ventures, and co-founder and chief innovation officer of Thrive, in a press release. "We envision a future where routine preventative care includes a blood test for cancer, just as patients are now routinely tested for early stages of heart disease. We know that if cancer is caught early enough, it can often be cured." CancerSEEK is currently being evaluated in DETECT, a prospective study in 10,000 healthy individuals underway in collaboration with Geisinger, to better understand test performance and the implementation of its findings into patient care. Thrive intends to conduct additional clinical studies to generate evidence to support regulatory approvals, inclusion in cancer screening guidelines and broad reimbursement. Press release