July 31, 2019 | July featured news, products, and partnerships from around the diagnostics community from numerous companies, universities, and organizations, including Illumina, PAREXEL, Caris Life Sciences, and more.
Illumina announced that the High Court of Justice, Chancery Division, Patents Court in the United Kingdom issued a judgment in its favor in the patent infringement suit filed against Ariosa Diagnostics. The Court found that Ariosa's Harmony non-invasive prenatal test infringed EP 1 524 321 and that the patent claims were valid. The patent is directed to the size selection of extracellular DNA in maternal plasma samples. Size selection boosts the fetal fraction, leading to fewer test samples being rejected for low fetal fraction. "We are pleased that the UK Court has again ruled in our favor, continuing to affirm the value of our NIPT portfolio and the significant contributions of the inventors in this field," Charles Dadswell, Senior Vice President and General Counsel at Illumina, said in a press release. Press release
PAREXEL announced the expansion of its capabilities to optimize drug development and commercialization in Asia/Pacific through a new Hong Kong presence established by its strategic healthcare consulting Health Advances subsidiary. The opening of Health Advances Asia Limited leverages the firm’s 20-plus years of experience in the Asia/Pacific region to help both local and multi-national companies looking to expand their global footprint. Health Advances’ locally-based, multilingual Hong Kong team will be led by Gary Cheng, who joins Health Advances with more than 30 years’ experience in the pharma, biotech, and medtech industries with such companies as Novartis, BD, Chiron Corporation, Alere, and Aventis (acquired by Sanofi). Additionally, Vivek Mittal, a long-time Partner at Health Advances in its San Francisco office, is now also based in Hong Kong and will work closely with Gary and the rest of the team to assist clients with their business needs. Press release
Caris Life Sciences announced that the University of Puerto Rico (UPR) has become the 28th member of its Precision Oncology Alliance. The Alliance is a collaborative network of leading cancer centers that is developing standards of care and best practices for the application of molecular profiling to advance precision cancer care. UPR, the foremost cancer institution in Puerto Rico, includes the UPR Hospital at Carolina, Ambulatory Clinic of UPR, Puerto Rico Medical Center in San Juan, and the Comprehensive Cancer Center UPR. It serves 85% of Puerto Rico's cancer patients and leads medical research on the island, driving discoveries in molecular science and the development of new drugs and innovative treatments. Press release
Rafael Pharmaceuticals has entered into an out-licensing agreement with Ono Pharmaceutical. The exclusive license agreement is for the development and commercialization of CPI-613 (devimistat), Rafael’s first-in-class clinical lead compound, which targets cancer metabolism enzymes, as well as its other related compounds. Under the terms of the agreement, Rafael will receive a one-time upfront payment of approximately $12.9 million and up to an additional approximately $150.3 million if certain development and commercial milestones are achieved. Rafael will also receive low-double digit royalties based on net sales of the products in Japan, South Korea, Taiwan and ASEAN (Association of Southeast Asian Nations) countries. ONO will have exclusive rights to develop and commercialize the Products for all indications in ONO’s territory. Rafael continuously retains all exclusive rights to develop and commercialize the Products outside of ONO’s territory. Press release
Certara announced the launch of version 19.6 of D360, its scientific informatics platform for drug discovery and development. Designed to meet the scientific researcher's need to quickly access, understand and share data, the D360 platform is delivered through its toolkits – small molecule discovery, biologics discovery, and pre-clinical translation – each tailored to meet specific research goals. D360 v19.6 expands the platform’s biologics discovery toolkit and world-class, self-service data access capabilities. D360 biologics discovery toolkit now enables representation, alignment, and analysis of peptide sequences and small sections of proteins in addition to oligonucleotide sequence representation. Peptide sequences can be aligned and color coded by property, while areas of sequence difference can be highlighted. This provides sequence analysis capabilities that help users derive sequence-activity relationships to optimize bioprofiles. "We are proud to report that D360 now provides medicinally-relevant sequence alignment and analysis, adding support for peptide modalities in addition to its current uses for oligonucleotides, antibodies and antibody-drug conjugates. Knowledge extracted from aligned peptide sequences (and short protein segments) is used for rational design, focusing on the monomers and motifs responsible for desired biological activity profiles," David Lowis, Senior Director of D360 at Certara, said in a press release. Press release
PerkinElmer has announced the first two CE-marked chemiluminescence immunoassays (ChLIA) for the detection of anti-Borrelia (Lyme disease) and anti-EBV/EBNA (Epstein-Barr Virus) antibodies on its EUROIMMUN RA Analyzer 10 system. The system, used in conjunction with the ChLIA products, functions as a compact automation solution in small- to medium-sized laboratories, or complements high-throughput-devices in large-sized laboratories. Test- and lot-specific information, including stored standard curves, are imported into the database by means of an RFID code, enabling error-free and convenient loading, along with efficient and secure test evaluation. The EUROIMMUN RA Analyzer 10 allows continuous loading—also as part of a testing line—to ensure every sample is processed with minimal effort and shorter reaction times as a single determination. The ChLIA technology further minimizes reaction times, with total analysis in 30 minutes or less. In addition, the preferred processing of emergency (STAT) samples gives laboratories with different requirements and sample volumes unparalleled flexibility in their laboratory routine. Press release.
PathogenDx announced that they have entered into a strategic partnership with Nationwide Laboratory Services/The Hayes Division, a national medical lab testing company based in Florida, to deploy PathogenDx's proprietary microarray technology for rapid strain identification in the dermatological and podiatric fungal testing industry. As part of the terms of the agreement, Nationwide Laboratory Services will create a Laboratory Developed Test (LDT) based on PathogenDx's testing technology. PathogenDx will serve as the Research & Development platform and Nationwide Labs will serve as the validator and launchpad for the services. "PathogenDx's agreement with Nationwide Laboratory Services will offer doctors, patients and insurers ultra-rapid and less expensive fungal testing results in 6 hours or less, versus the industry standard of 72+ hours or more," Milan Patel, CEO and Co-founder of PathogenDx, said in a press release. "We all know that DNA-based tests are far more rapid and accurate than plating cultures, but what PathogenDx uniquely offers is multiple pathogen testing as one multiplex test in 6 hours or less. We have already developed analogous testing for the fungal species needed in the microbial testing market in our other industry verticals. What this partnership with Nationwide Labs will allow us to do is to take that knowledge and expand into the medical testing market. A breakthrough moment for our multi-patented technology, this partnership allows us to move into the multi-billion dollar medical microbial testing market. This is a very exciting announcement for us." Press release
Quanterix announced that it has entered into a definitive agreement to acquire privately held Uman Diagnostics for $22.5 million, comprised of $16 million in cash plus $6.5 million in Quanterix common stock. Uman, based in Umeå, Sweden, supplies Nf-L antibodies and ELISA kits, which are widely recognized by researchers and biopharmaceutical and diagnostics companies world-wide as the premier solution for the detection of Nf-L to advance the development of therapeutics and diagnostics for neurodegenerative conditions. Nf-L has seen a dramatic growth in the last three years since Quanterix developed the first assay using Uman’s antibodies that could reliably measure Nf-L in blood. This innovation allowed research, previously limited primarily to cerebrospinal fluid (CSF), to expand significantly and has led many of the world’s foremost neurology researchers and clinicians to conclude that Nf-L may be the most clinically relevant brain biomarker available today. Nf-L has demonstrated utility in the diagnosis, prognosis, and monitoring of a wide range of conditions including Alzheimer’s Disease, Multiple Sclerosis, Parkinson’s Disease, traumatic brain injury (TBI), ALS, Huntington’s Disease, and others. Press release
Renalytix AI announced positive study results have been published in the Journal of American Society of Nephrology (JASN), in a paper entitled, A Peripheral Blood Gene Expression Signature to Diagnose Subclinical Acute Rejection. The results are part of a continuing research program from the FractalDx kidney transplant diagnostic portfolio and demonstrate a blood test can diagnose kidney rejection before clinical signs of kidney damage and may be used to tailor immunosuppressive therapy. The results demonstrate key information can be provided to a transplant clinician without the need for an invasive kidney biopsy. This post-transplant diagnostic, known as FractalDx ACR, is the second of the candidate tests from the FractalDX portfolio in-licensed by RenalytixAI from the Icahn School of Medicine at Mount Sinai and is in addition to study results published in the Journal of Clinical Investigation (JCI) Insight, detailing a pre-transplant test for the recipient, now called Fractal Baseline Dx, for prediction of early transplant rejection. The lead investigator for both studies was Dr. Barbara Murphy, Dean for Clinical Integration and Population Health, Professor and System Chair Medicine and Nephrology, at the Icahn School of Medicine at Mount Sinai (ISMMS) in conjunction with investigators from the Genomics of Chronic Allograft Rejection study (GoCAR) and collaborators from the University Hospital, Leuven, Belgium. Press release
Credo Biomedical announced the launch of their new molecular diagnostic platform, VitaPCR, and its Influenza A/B assay. Based on real-time polymerase chain reaction (real-time PCR), VitaPCR Influenza A/B is a true point-of-care platform that combines ease of use, speed and affordability. It delivers lab accurate results in less than 20 minutes with only 2 minutes hand-on time at the same price level as traditional lateral flow tests. Combining speed, accuracy, and ease-of-use required for any advanced POC molecular diagnostic platform, VitaPCR Influenza A/B delivers rapid and actionable results for the same price level as RIDTs, making molecular diagnostic tools highly accessible to patients and affordable to all. "There is a clear need for early diagnostic for influenza as treatment is most effective in the first 48hrs of symptom onset. Point of Care molecular solution is the best option for optimal patient care outcome,” said Stephen Kao, CEO of Credo Biomedical, in an official statement. "Credo's solution is based on proven science with special care in ease-of-use and unprecedented affordability. This affordability will make our solution accessible to the masses to help combat influenza."
The Synexus HealthyMinds Registry has launched and is seeking 30,000 US participants for a five-year study examining the lifestyle and genetic risk factors impacting cognitive function over time. Supporting researchers' goal of identifying ways to prevent and treat Alzheimer’s disease and other forms of dementia, the registry is open at www.SynexusHMR.com for US adults age 50 or older who do not have dementia. Synexus HMR is a collaboration between Accelerated Enrollment Solutions (AES) – a business unit of Pharmaceutical Product Development (PPD), the global contract research organization – and the University of Exeter in the United Kingdom. Press release