Meridian Bioscience, Inc. | March 31, 2022
Meridian Bioscience, Inc. (NASDAQ: VIVO), a leading global provider of diagnostic testing solutions and life science raw materials, announced today the launch of two new master mixes that detect DNA and RNA in crude blood samples down to a single copy – enabling the earliest detection of cancer using non-invasive liquid biopsy. These two innovative mixes, Lyo-Ready™ Direct DNA qPCR Blood Mix and Lyo-Ready™ Direct RNA/DNA qPCR Blood Mix, are designed for applications that require ultra-sensitive detection, such as liquid biopsy. This breakthrough technology is the first blood-specific, inhibitor-tolerant, and lyophilizable chemistry that enables extraction-free qPCR/RT-qPCR for liquid biopsy analysis at a performance level on par with traditional qPCR from purified nucleic acids.
Liquid biopsy is a non-invasive alternative to tissue biopsy and offers ultra-sensitive detection of tumor-associated DNA or RNA from biofluids such as blood. Sample types like whole blood, serum, plasma, and the anticoagulants used for specimen stabilization contain PCR inhibitors that can significantly reduce detection sensitivity and may cause false-negative results. Inhibitors are usually removed by DNA/RNA extraction; however, that approach is very inefficient and increases assay time, cost, and the risk of contamination or error. Meridian's innovative Lyo-Ready™ Blood-Specific Master Mixes do not require extraction and are proven to excel with crude blood and its derivatives without the need to remove inhibitors. These groundbreaking mixes can help improve patient outcomes by enabling early cancer detection by delivering assay sensitivity down to one copy of DNA. Meridian's new mixes are formulated with lyophilization excipients, making them compatible with lyophilization to create room-temperature stable molecular diagnostic assays. Not only does this allow maximum sample input in the liquid biopsy analysis, but it also eliminates the need for cold chain storage of the finished test kit, limiting our customer's environmental impact.
We are excited to expand our sample-specific molecular range with the market's first lyophilizable, and inhibitor-tolerant master mixes designed for direct amplification of nucleic acids from liquid biopsy. It is a truly disruptive technology that makes the early detection of cancer biomarkers directly from liquid biopsy a reality. We are proud of being the technology innovator enabling efficient and more cost-effective diagnostic assay development to help clinicians deliver the quickest, most accurate diagnosis for patients."
Florent Chang-Pi-Hin, Ph.D., Vice President, Global Research and Development.
About Meridian Bioscience, Inc.
Meridian is a fully integrated life science company that develops, manufactures, markets, and distributes a broad range of innovative diagnostic products. We are dedicated to developing and delivering better solutions that give answers with speed, accuracy, and simplicity that are redefining the possibilities of life from discovery to diagnosis. Through discovery and development, we provide critical life science raw materials used in immunological and molecular tests for human, animal, plant, and environmental applications. Through diagnosis, we provide diagnostic solutions in areas including gastrointestinal and upper respiratory infections and blood lead level testing. We build relationships and provide solutions to hospitals, reference laboratories, research centers, veterinary testing centers, physician offices, diagnostics manufacturers, and biotech companies in more than 70 countries worldwide.
Aegle Therapeutics | October 06, 2020
Aegle Therapeutics Corporation, a first-in-class biotechnology company committed to delivering cell-free therapy to patients affected by severe dermatological conditions, today announced that the FDA has granted Rare Pediatric Disease (RPD) Designation to AGLE-102™ for the treatment of dystrophic epidermolysis bullosa (DEB), a skin blistering disorder. AGLE-102 is a composite of mesenchymal stem cell-derived extracellular vesicles that deliver proteins, genetic material and regenerative healing factors to diseased and damaged tissue. "The FDA's grant of Rare Pediatric Disease designation following its earlier grant of Fast Track Designation to AGLE-102 for DEB underscores the significant unmet medical need of children and adults living with this debilitating disease. AGLE-102 has the potential to be the first multifaceted approach to treat this rare patient population," said Shelley Hartman, CEO of Aegle Therapeutics. The FDA grants Rare Pediatric Disease designation for diseases that primarily affect children ages 18 years or younger and fewer than 200,000 persons in the U.S. If Aegle's new drug application ("NDA") for DEB is approved, Aegle may receive a priority review voucher from the FDA, which can be redeemed to obtain priority review for any subsequent marketing application or may be sold to another company for their programs.
PharmaCyte Biotech | September 02, 2020
PharmaCyte Biotech, Inc. (OTCQB: PMCB), a clinical-stage biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box®, announced today that it has submitted an Investigational New Drug application (IND) to the U.S. Food and Drug Administration (FDA) for a planned Phase 2b clinical trial in locally advanced, inoperable pancreatic cancer (LAPC). PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, commented, “Submitting this IND is the most important milestone the Company has met thus far in the clinical development of our leading product candidate. That’s our therapy to combat what is truly a global unmet medical need for those patients with LAPC whose tumors no longer respond to the first line treatments of either Abraxane® plus gemcitabine or FOLFIRINOX. “Now that the IND has been submitted, we must wait a minimum of 30 calendar days before initiating our clinical trial. During this time, the FDA has an opportunity to review the IND to ensure that it’s complete and that the planned clinical trial research patients will not be subject to unreasonable risk. It also gives the FDA time to ask for more information and clarification about the information submitted.