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Vela, Ortho, UC Berkley, And More: News From March 2019

April 1, 2019 | March featured news, products, and partnerships from around the diagnostics community from numerous companies, universities, and organizations, including Vela, Ortho, UC Berkley, and more.

Rare Genomics Institute (RG) announced a partnership with Dante Labs. RG is an international non-profit that gives rare disease patients access to state-of-the-art genomics sequencing technology, connections to scientists and researchers and philanthropic opportunities. Dante Labs is a genetic testing company specialized on whole genome sequencing and rare diseases. Through this partnership, Dante Labs has agreed to provide pro-bono Whole Genome Sequencing to select patients from Rare Genomics. Their test called, Whole Genome Sequencing (Full DNA Analysis), analyzes 100% of the DNA and provides personalized reports based on the patient’s medical history and symptoms. “Shortening the diagnostic odyssey is our core mission, and Dante Labs is helping our patients who have nowhere else to go,” said Romina Ortiz, COO of the Rare Genomics Institute, in a press release. As the utility of next generation sequencing has become well known, it is important to help patients across the globe determine what test they may benefit from. However, access to genetic testing varies significantly. In some cases testing is not covered by insurance, and in some countries the test may not be readily available. Rare Genomics and Dante Labs will focus their efforts on both child and adult rare disease patients around the world who cannot afford the test. Press release

Vela Diagnostics announced the submission of the Sentosa SQ HIV Genotyping Assay to the US Food and Drug Administration (FDA). The Sentosa SQ HIV Genotyping Assay is intended for the detection of HIV-1 Group M genomic drug resistance mutations (DRMs) in the protease, reverse transcriptase, and integrase regions of the pol gene. The test uses the plasma of patients diagnosed with HIV-1 infection. This submission follows the U.S. FDA clearance of Vela’s Sentosa SA201 HSV-1/2 PCR Test, received in February 2018. “This submission of our first next generation sequencing assay to the US FDA signifies our continued commitment to bringing relevant products to clinicians to help their patients in globally regulated markets around the world, which is among Vela’s top priorities. With the NGS HIV Genotyping assay, laboratories will now have a sample-to-answer solution that addresses the needs of HIV treatment,” commented Sam Dajani, Chairman of the Board, in a press release. The Sentosa SQ HIV Genotyping Assay is validated on the highly automated Sentosa NGS workflow which enables automated RNA extraction, library construction, template preparation, sequencing, data analysis, and automated reporting. The Sentosa NGS workflow also allows clear sample traceability, with seamless LIS integration and connectivity. Press release

Ortho Clinical Diagnostics announced the launch of four new key assays to meet the demand of the rapidly growing diagnostics market in China. This product launch, in collaboration with Beijing Leadman Biochemistry, based in Beijing, expands Ortho's offerings for renal, liver, and cardiac testing and adds the following assays that are central for improving the efficiency of STAT labs: Cystatin C, α-Hydroxybutyrate Dehydrogenase (HBDH), Homocysteine (HCY) and Total Bile Acid (TBA). "Ortho has a longstanding commitment to deliver the right menu that drives medical value for our customers," said Heidi Casaletto, head of clinical labs menu business field at Ortho, in a press release. "We're thrilled to collaborate with an innovative organization like Leadman to accelerate our presence in China, and most importantly, to offer a new portfolio of MPA assays that will help to make hospital STAT labs more flexible and efficient." Press release

Group K Diagnostics (GKD) has signed an agreement with the Centers for Disease Control and Prevention (CDC) to design and evaluate a prototype reverse transcriptase loop-mediated isothermal amplification (RT-LAMP) assay for the detection of the Zika virus (ZIKV) RNA that can be performed by clinical personnel or health care practitioners in resource-limited areas where real-time RT-PCR instrumentation is not available. Currently, the majority of suspected ZIKV positive specimens are sent to a state public health laboratory or the CDC. A point-of-care solution would vastly expedite the testing and diagnosis process for those in both suburban and remote geographic regions, and allow care providers to update patient care plans and implement infection control procedures at the primary visit. ZIKV has emerged as a major global public health concern in the last three years. "With my background in point of care diagnostics, I've seen first-hand the impact point-of-care testing can have on regions with limited resources, and the potential is truly remarkable," said Reshma Rajan, diagnostic engineer, GKD, in a press release. "Our team is honored to partner on this monumental advancement of point-of-care diagnostics, and we look forward to working with the CDC to bring a new, life-saving technology to market." The goal of this collaboration is to transform the test tube-based RT-LAMP assay for the detection of ZIKV developed by the CDC (PCT Application No. PCT/US2018/029738) into a non-invasive, rapid detection technology that can be performed in a clinical setting.  This access to rapid testing will also be an important tool that can be used throughout pregnancy – a necessity for prenatal care of women living in areas at risk of ZIKV transmission. The team at GKD is contributing expertise in microfluidic point-of-care testing and a deep understanding of the logistical demands in resource-limited areas. Press release

Personal Genome Diagnostics announced that it has applied the CE mark to PGDx elio plasma resolve. It is the first kitted plasma-based NGS oncology test to have that certification, enabling greater access to genomic testing for cancer patients in Europe. PGDx elio plasma resolve is a qualitative in vitro diagnostic test that uses targeted high throughput, parallel-sequencing technology to detect single nucleotide variants (SNVs), small insertion/deletions (indels), amplifications, rearrangements, and microsatellite instability (MSI) in a broad multi-gene panel in circulating cell-free DNA (cfDNA) isolated from plasma samples. It encompasses several clinically actionable variants across tumor types, enabling more informed treatment decisions. “We are extremely proud of this important milestone,” Doug Ward, Chief Executive Officer, said in a press release. “Our vision is to improve clinical insight, speed of results, and health economics by delivering a portfolio of regulated tissue-based and liquid biopsy genomic products to laboratories worldwide. The CE mark of PGDx elio plasma resolve allows us to bring this product to Europe, providing greater access to patients who could benefit from genomic testing, particularly those who cannot provide tissue samples.” Press release

Essenlix announced it is providing an instant mobile health self-test platform, iMOST, that allows any person to accurately perform a diagnostic/health test her/himself, anywhere, anytime, using a single drop of body fluid and a smartphone, all within 60 seconds, at a low cost, with the result sent immediately to professionals. iMOST (Instant Mobile Self-Test), first of the type, is based on out of-the-box thinking and a fundamentally different paradigm that is realized through uniquely implementing nanotechnology, advance imaging, and artificial intelligence/machine learning into diagnostic testing. iMOST delivers clinical lab-quality test results using a simple device, even when a sample, device, process, and operation are imperfect. Diagnostic lab-testing is a vital and necessary procedure for diagnosing diseases and monitoring health conditions. The iMOST platform is removing one of the largest barriers in digital health by replacing a conventional inconvenient, time consuming, and expensive lab-test with an instant mobile self-test platform. Essenlix aims to make iMOST available to most of the world’s 7 billion population. Press release

imaware has released a study utilizing its platform that has been peer reviewed by Clinical Chemistry and Laboratory Medicine (CCLM). The company is the first at-home blood-testing platform to validate and share its data with consumers and medical professionals. imaware offers at-home tests for Celiac Disease and Rheumatoid Arthritis, with cardiovascular health, liver disease, and prostate health tests launching later this year. The company's published results in CCLM can be found here. Press release

A team of engineers at the UC Berkeley and the Keck Graduate Institute (KGI) of The Claremont Colleges combined CRISPR with electronic transistors made from graphene to create a new hand-held device that can detect specific genetic mutations in a matter of minutes. The device, dubbed CRISPR-Chip, could be used to rapidly diagnose genetic diseases or to evaluate the accuracy of gene-editing techniques. The team used the device to identify genetic mutations in DNA samples from Duchenne muscular dystrophy patients. Doctors and geneticists can now sequence DNA to pinpoint genetic mutations underlying a host of traits and conditions, and companies like 23andMe and AncestryDNA even make these tests available to curious consumers. But unlike most forms of genetic testing, including recently developed CRISPR-based diagnostic techniques, CRISPR-Chip uses nanoelectronics to detect genetic mutations in DNA samples without first "amplifying" or replicating the DNA segment of interest millions of times over through a time- and equipment-intensive process called polymerase chain reaction, or PCR. This means it could be used to perform genetic testing in a doctor’s office or field work setting without having to send a sample off to a lab. "CRISPR-Chip has the benefit that it is really point of care, it is one of the few things where you could really do it at the bedside if you had a good DNA sample," Niren Murthy, professor of bioengineering at UC Berkeley and co-author of the paper, told Berkley News. "Ultimately, you just need to take a person’s cells, extract the DNA and mix it with the CRISPR-Chip and you will be able to tell if a certain DNA sequence is there or not. That could potentially lead to a true bedside assay for DNA." Full Article