January 30, 2019 | January featured news, products, and partnerships from around the diagnostics community from numerous companies, universities, and organizations, including Biocare, First Light Diagnostics, the government of Ghana, and more.
Biocare announced the release of the VALENT IVD (in vitro diagnostic) automated staining platform. VALENT is the industry's first fully automated, open platform, merging high-throughput, and quality staining with a powerful and intuitive user interface. VALENT overcomes the limitations of closed systems with its unique open platform, allowing reagents from multiple sources and providing top-tier IHC results. VALENT transforms clinical, pharmaceutical, and research laboratories by providing an easy-to-use fully automated platform, 48-slide capacity, multiplex IHC capability, and high-quality staining. With VALENT, the IHC protocol is completely automated; performing fast, non-toxic online deparaffinization and utilizing a novel, patent-pending, continuous antigen retrieval dispense technology. With VALENT, Biocare offers a full line of high quality, ready-to-use reagents that have been optimized for maximum performance supporting convenient load-and-go capability, and ultimately enhancing laboratory workflow. The open platform of VALENT enables users to apply enzyme pre-treatments, antibodies, detections, or chromogens from any source. These combined capabilities significantly increase laboratory efficiency, flexibility and turn-around time; freeing up valuable time and resources. Press release
Veracyte announced that it has entered into a long-term strategic collaboration with Johnson & Johnson Innovation and the Lung Cancer Initiative at Johnson & Johnson to advance the development and commercialization of novel diagnostic tests to detect lung cancer at its earliest stages, when the disease is most treatable. The collaboration will build upon foundational "field of injury" science – where genomic changes associated with lung cancer can be identified with a simple brushing of a person's airway – to develop new interventions that can save lives. Under terms of the agreement, Veracyte and the Lung Cancer Initiative at Johnson & Johnson, whose mission is to prevent, intercept, and cure lung cancer, will combine clinical study cohorts involving more than 5,000 patients with multiple years of clinical outcome data. Veracyte will contribute bronchial and nasal samples from its clinical trials, which are part of the company's extensive lung cancer-focused biorepository. Veracyte will deploy its RNA whole-transcriptome sequencing platform, utilizing high-dimensional data and machine learning pipelines on the combined cohort, providing the most comprehensive genomic content available which the Lung Cancer Initiative at Johnson & Johnson will have access to for therapeutic purposes. The collaboration is expected to accelerate two key lung cancer programs for Veracyte. First, the development of the first non-invasive nasal swab test for early lung cancer detection and, secondly, the commercialization of its Percepta classifier on the company’s RNA whole-transcriptome sequencing platform, which, as a result of this collaboration, is expected to launch in the first half of 2019. Press release
First Light Diagnostics announced the completion of an oversubscribed $8.25 million Series A-2 financing. The transaction closed this morning. The company, a developer of breakthrough automated products for rapid, sensitive, and cost-effective diagnosis of life-threatening, antibiotic-resistant infections, will use the new funding to continue development of the MultiPath technology to rapidly detect hospital infections and determine their susceptibility to specific antibiotics. This includes preparation and support for product commercialization and launch in early 2020. The financing includes new investment partners from Think.Health Ventures, 10x Group, and Beacon Angels, along with numerous new individual investors and continued participation from current shareholders, such as: LRV Health and Life Science Angels. First Light Diagnostics is developing and preparing to commercialize, innovative diagnostic products for rapid, sensitive and cost-saving detection of life-threatening infections, and combating the spread of antibiotic resistance. Based on its proprietary MultiPath detection technology, First Light’s products combine the clinical performance of the most advanced commercial laboratory tests with speed, cost-effectiveness, and ease-of-use. Press release
The Government of Ghana announced a new public-private partnership to improve the diagnosis and accelerate treatment for people with sickle cell disease (SCD), making Ghana the first African country to commit to offering the global standard of care for their people with SCD. The Ministry of Health of Ghana, Ghana Health Service, the Sickle Cell Foundation of Ghana, and global medicines company Novartis have signed a Memorandum of Understanding to create a holistic approach to help tackle the disease. The partnership aims to improve and extend the lives of people with SCD through a comprehensive approach to screening and diagnosis; treatment and disease management; training and education; and elevating basic and clinical research capabilities. Specifically, the partners aim to collaborate on field testing and implementation of SCD treatment guidelines, the establishment of centers of excellence across regions and the implementation of newborn screening at these centers. “We are pleased to partner with the Sickle Cell Foundation and Novartis in order to address sickle cell disease in Ghana,” Hon. Kwaku Agyemang-Manu, Minister of Health of Ghana, said in a press release. “We are committed to put SCD among the priorities on our national health agenda and to put the required resources behind it. We invite like-minded partners from the public and private sectors to join us in this effort. Together, we can actively contribute to ending preventable deaths of newborns and children under 5 years of age, as set out in the UN Sustainable Development Goals.” Sickle cell disease is recognized by the World Health Organization as a public health priority and a neglected health problem in sub-Saharan Africa. Approximately 80% of individuals with SCD globally are born in sub-Saharan Africa, and there is evidence to suggest that more than half of affected individuals may die before the age of five due to preventable complications. In Ghana, it is estimated that 15, 000 babies are born with sickle cell disease every year. Press release
CellMax Life presented new findings at the ASCO Gastrointestinal Cancer Symposium in San Francisco this month, revealing significant advancement in the fight against colorectal cancer. The results from this study show CellMax Life’s blood test, based on its proprietary CMxTM platform, can detect pre-cancers (adenomas) with close to 90% accuracy (Area Under the ROC Curve). Results of the study show that based on enumeration of pre-cancer cells, it is possible to accurately differentiate between healthy patients and those with pre-cancer. Further, an increase in cell count was significantly correlated with an increase in disease severity. “Colorectal cancer is the second deadliest cancer in the U.S., with 150,000 new cases and $14 billon spent on treatment annually,” said Atul Sharan, Co- Founder and CEO of CellMax Life, in a press release. “We’re working to change that. Colorectal cancer is preventable when adenomas are detected and removed. In fact, adenoma removal reduces mortality rates from colorectal cancer by 53%. CellMax Life’s FirstSightCRC test will increase compliance with colorectal cancer screenings and increase detection rates at the adenoma stage, saving lives.” The FirstSightCRC TM test detects pre-cancer and cancer cells in blood. The test utilizes a patented technology comprising a micro-fluidic chip with proprietary nano (non-sticky) layer for cell capture, high-affinity antibodies, and a special air-foam release technology to gently release the captured cells enabling high intact cell preservation, and thereby high detection rates of pre-cancer. Press release