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.
Amyris, Inc. | January 25, 2022
Amyris, Inc. a leading synthetic biotechnology company accelerating the world's transition to sustainable consumption through its Lab-to-Market™ operating platform announces that it has agreed to exclusive terms to acquire the assets of MenoLabs, LLC, a women-founded company to treat menopause symptoms, drive research for women's health and improve society's understanding of menopause.
Amyris previously communicated its intention of launching a new consumer brand to provide science-backed, wellness and personal care products for the high growth menopause market in 2022. The acquisition of MenoLabs will serve as a catalyst to accelerate growth and establish a leadership position in the fast-growing menopause market.
MenoLabs, a growing women's wellness brand is focused on addressing perimenopause and menopause symptoms. MenoLabs is one of few companies offering research-backed all-natural treatments of menopause symptoms. Over the past two years, MenoLabs has developed and launched eight products, including its lead product, MenoFit, an all-natural menopause relief supplement. MenoLabs generates a subscription-based, recurring revenue stream via its website, in addition to the Subscribe & Save option offered via the Amazon channel. The company is further expanding its omnichannel by penetrating retail channels in 2022. Additionally, MenoLabs launched MenoLife, a highly rated perimenopause and menopause health tracker app which helps users track and analyze more than 40 menopause-related symptoms. MenoLife also has created an online forum where users can comment and react to posts.
Menopause symptoms impact the lives of approximately 25 million women per year and 6,000 women in the U.S. enter perimenopause every day (2.2 million each year). By 2025, there will be over one billion people experiencing menopause in the world or around 12% of the entire world population. Stigma, lack of open discussion, and a small product offering at an affordable price are barriers to care for women. The menopause market was valued at around $15 billion in 2020 and is expected to reach approximately $23 billion by 2028.
"We are very impressed with the MenoLabs offering which is synergistic with our science-based approach to real-world health and wellness issues. We are committed to empowering women and creating a platform to support them with our leading science and wellness technology platform. Women deserve products and solutions that work during this period in their lives. Our acquisition of the products and app that the MenoLabs team has built accelerates Amyris' entry into the menopause market. We expect the combination of MenoLabs and the previously announced menopause brand with Naomi Watts to have the potential to deliver an estimated $30 million in revenue in their first year and expect significant growth potential in the years ahead. We continue to execute on our growth strategy diversifying our consumer offering in Clean Beauty, Health and Wellness end-markets, continuing the strong growth momentum from 2021 into the current quarter."
John Melo, President and Chief Executive Officer of Amyris
Amyris is a leading synthetic biotechnology company, transitioning the Clean Health & Beauty and Flavors & Fragrances markets to sustainable ingredients through fermentation and the company's proprietary Lab-to-Market™ operating platform. This Amyris platform leverages state-of-the-art machine learning, robotics and artificial intelligence, enabling the company to rapidly bring new innovation to market at commercial scale. Amyris ingredients are included in over 20,000 products from the world's top brands, reaching more than 300 million consumers. Amyris also owns and operates a family of consumer brands that is constantly evolving to meet the growing demand for sustainable, effective and accessible products.
MenoLabs was founded to fundamentally change how menopause is addressed. The brand's mission is to provide options to treat menopause symptoms, drive research for women's health and change how society approaches, views and educates around the topic of menopause. MenoLabs has developed a line of all natural, proprietary supplements focused on treating perimenopause and menopause symptoms, in addition to MenoLife, a leading menopause health tracker app that provides women a voice and community. MenoLife also provides symptom tracking to further fuel research and advancements in women's health.
Meridian | June 21, 2022
Meridian Bioscience, Inc. (NASDAQ: VIVO), a leading global provider of diagnostic testing solutions and life science raw materials, announced today two new sample-specific master mixes, Lyo-Ready™ Direct DNA qPCR Stool Mix, and Lyo-Ready™ Direct RNA/DNA qPCR Stool Mix. These innovative master mixes improve the molecular detection of DNA and RNA from crude fecal specimens while allowing room temperature stabilization of diagnostic assays.
Stool samples are used in many gastrointestinal diagnostic tests to screen for harmful bacteria, fungi, viruses, autoimmune conditions, and colorectal cancer (CRC). The fecal occult blood test (FOBT) has been the most widely used gastrointestinal immunoassay to screen CRC for over three decades. However, recent large-scale studies have shown that the FOBT lacks the sensitivity to detect early stages of CRC. Better diagnostic tools are needed to improve assay accuracy, sensitivity, and affordability. Molecular testing is the newest alternative and offers significant improvement in sensitivity and accuracy, especially when multiple targets are detected in the results of a multiplex test. Detection of DNA or RNA from stool is challenging because it contains an array of PCR inhibitors including bile salts, polysaccharides, and catabolic substances. To overcome these challenges, assays typically require expensive and time-consuming sample processing and extraction steps which increase the time to results and cost – ultimately delaying physician diagnosis and patient treatment.
Meridian's new Lyo-Ready™ Direct DNA qPCR Stool and Lyo-Ready™ Direct RNA/DNA qPCR Stool Mixes remove the need for time-consuming nucleic acid extraction or lengthy component optimization. This enables test developers to quickly develop faster and more sensitive assays for stool sample analysis. In addition, the mixes can be used in liquid or lyophilized format when ambient temperature assay stabilization is needed, removing the need for cold storage.
The use of Lyo-Ready™ Direct qPCR Stool mixes for DNA and RNA is ideal for cancer biomarker detection, early cancer detection, and cancer treatment monitoring where assay sensitivity can be lifesaving. The specific adaptation of our chemistries to stool specimens makes our master mixes the perfect tool for any developer seeking faster new product introduction, shorter time to results, or the ability to transform a wet assay to an ambient temperature-stable assay with minimum developmental time."
Florent Chang-Pi-Hin, Ph.D., Vice President of Research & Development - Life Science.
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 around the world.