Invivoscribe Releases the LymphoTrack Dx TRB Assay as CE-Marked IVD Kit, Completing the NGS Clonality Suite for the MiSeq Platform
SAN DIEGO, May 15, 2018 (GLOBE NEWSWIRE) -- Invivoscribe Technologies Inc., a global company with decades of experience providing clonality and biomarker test solutions for the fields of oncology and personalized molecular medicine, today announced the release of the LymphoTrack® Dx TRB Assay for the Illumina® MiSeq® platform, a CE-marked next-generation sequencing (NGS) assay kit for in vitro diagnostic (IVD) use. Invivoscribe is the only company offering a complete suite of CE-marked NGS clonality assays designed to assess clonality for both diagnostic and tracking purposes. The LymphoTrack Dx TRB Assay for the ThermoFisher Scientific® Ion PGM(TM) and Ion S5(TM) instruments will be released later this year.
Leukemias and lymphomas generally originate from the malignant transformation of individual lymphoid cells, causing the vast majority of lymphoid malignancies to share one or more cell-specific or "clonal" rearrangements. The LymphoTrack Dx TRB assay identifies clonal TRB VB-(DB-)JB rearrangement sequences, and the accompanying LymphoTrack Dx bioinformatics software provides a clear summary of the frequency distribution. These clonal sequences can be used to monitor minimal residual disease (MRD) in longitudinal studies, which track the disease as well as the effectiveness of therapies aimed towards their eradication.
The LymphoTrack Dx TRB Assay completes the menu of Invivoscribe's CE-marked clonality assays on the MiSeq®, leveraging the unparalleled accuracy and sensitivity of next generation sequencing (NGS), enabling small and large laboratories alike to identify and track clonal rearrangements. Invivoscribe's CE-marked clonality kits, which allow single step PCR library generation and come with bioinformatics software designed to run on standard Windows platforms within customer laboratories, allow for comprehensive multiplex testing of any combination of samples and LymphoTrack Dx assays (e.g. IGH Leader, IGH FR1, IGH FR2, IGH FR3, IGK, TRG, and TRB), thus significantly reducing both laboratory costs and turnaround times. Deep-sequencing NGS assays represent a significant improvement over existing PCR-based assays. They accurately identify the majority of gene rearrangement sequences, or clonotypes, which can subsequently be used for MRD tracking. Each kit includes user-friendly LymphoTrack Dx MiSeq® software that automates the sorting and tracking of each sample and target, interprets sequence data, and generates detailed reports.
"We are pleased to offer the first commercially available NGS CE-marked IVD TRB kit, with bioinformatics software, for clonality assessment and tracking. Innovative products like our NGS-based LymphoTrack Dx Assays directly benefit patients by guiding precision treatments and enabling exceptionally sensitive monitoring for disease reoccurrence," said Dr. Jeffrey Miller, CSO and CEO of Invivoscribe.
Invivoscribe Technologies, Inc. is a privately held biotechnology company dedicated to improving the quality of healthcare worldwide by providing high quality, standardized reagents, tests, and bioinformatics tools to advance the fields of personalized molecular diagnostics and personalized molecular medicine. The extensive product portfolio includes RUO test kits, CE-marked IVDs, including IdentiClone®, LeukoStrat® and LymphoTrack Dx Assays with LymphoTrack Dx Software to assess clonality, somatic hypermutation and monitor MRD. Invivoscribe's PCR and NGS-based tests, reagents and bioinformatics tools are currently being used in more than 700 clinical and research laboratories in more than 160 countries. Invivoscribe currently has clinical laboratories located in the U.S.A., Europe and Japan which provide international access to harmonized CLIA, CAP, and ISO 15189 accredited clinical testing and contract research organization (CRO) services. Invivoscribe's clinical laboratories also offer comprehensive MyAML®, MyHeme®, MyMRD®, and custom gene panels, that when used in combination with Invivoscribe's proprietary MyInformatics(TM) Software can identify and track primary driver mutations as well as the subclonal architecture and emergence of new driver mutations in patients with hematologic disease. Invivoscribe also has a subsidiary in Shanghai, China that is now supporting clinical trial work in China. Invivoscribe has a successful track record of partnerships with global pharmaceutical companies developing and commercializing companion diagnostics. As a world leader, Invivoscribe has long embraced the value of quality systems, and develops all innovative products, including bioinformatics software in compliance with ISO 13485 design controls, making them eligible to be submitted to worldwide regulatory authorities for registration.
For additional information please visit www.invivoscribe.com.
Kevin Dobyns 858-224-6600
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Invivoscribe, Inc. via Globenewswire
Om Nasdaq GlobeNewswire
One Liberty Plaza - 165 Broadway
NY 10006 New York
+1 212 401 8700http://www.nasdaqomx.com
NASDAQ (NASDAQ: NDAQ) is a leading provider of trading, exchange technology, information and public company services across six continents.
Følg saker fra Nasdaq GlobeNewswire
Registrer deg med din epostadresse under for å få de nyeste sakene fra Nasdaq GlobeNewswire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra Nasdaq GlobeNewswire
CamundaCon 2018 to Feature Speakers from Goldman Sachs, 24 Hour Fitness, Universal Music and Vodafone20.8.2018 14:00 | Pressemelding
CamundaCon Will Convene 400+ Software Architects, IT Managers and DevOps Professionals to Discuss Workflow Automation Challenges in the Age of Containers and Microservices BERLIN, Aug. 20, 2018 (GLOBE NEWSWIRE) -- Camunda today announced the agenda for CamundaCon, the preeminent conference focused on new innovation in workflow automation for digital businesses. The two-day conference will feature twenty three sessions across two tracks and will take place September 20-21, 2018, at Radialsystem Berlin. Hundreds of participants will gather to discuss the rise of microservices and event-driven architectures in business process management (BPM), and the key role workflow automation is playing in digital transformation. To see full agenda or to register to attend, please visit https://camunda.com/events/camundacon/. The workflow automation market is expected to reach nearly $17 billion by 2023, up from $4.7 billion in 2017.1 As companies across industries accelerate their digital transforma
Ondot’s Mobile Card Controls Provide Protection to Thousands of Banks from ATM Heist Threat17.8.2018 22:47 | Pressemelding
-Card controls counter threat of FBI’s warning on unlimited ATM cash out crime - Santa Clara, Calif., Aug. 17, 2018 (GLOBE NEWSWIRE) -- US mainstream media is reporting on a FBI warning to banks of an impending cybercrime wave targeting ATMs in which thieves seek to steal millions of dollars by using cloned cards for fraudulent withdrawals. Ondot, the global leader in mobile payments services, provides consumers a simple protection with mobile-based card controls that can restrict ATM transactions without completely shutting off the card for legitimate needs. Ondot’s mobile controls can give consumers the ability to restrict transactions specifically for ATMs while leaving their cards active for in-person purchases, eCommerce, and other purchases. By locking the account’s use at an ATM, consumers can work with their financial institution to ensure other security best practices are in place while knowing that even a spoofed card will be unable to withdraw cash. If emergency cash is need
SEMAFO: Armed Incident in Bobo Area17.8.2018 15:48 | Pressemelding
MONTREAL, Aug. 17, 2018 (GLOBE NEWSWIRE) -- SEMAFO Inc. (TSX:SMF) (OMX:SMF) regrets to report that a bus transporting employees from the town of Bobo-Dioulasso to the Mana Mine in Burkina Faso was shot at by armed bandits this morning. In the exchange of fire between the policemen and bandits, one SEMAFO national employee and one sub-contractor employee lost their lives. Operations at the Mana Mine, located 80 kilometers from the incident, are not affected. Early analysis suggests that this incident and the armed incident that occurred in the Est region six days ago are unrelated. However, the Corporation will be increasing its security measures at Mana and take appropriate steps to ensure the safety of the mine and of its employees. The Corporation would like to express its sincere sympathy to families of the victims. About SEMAFO SEMAFO is a Canadian-based mining company with gold production and exploration activities in West Africa. The Corporation operates the Mana Mine in Burkina
ThalesNano Energy Introduces H-Genie™: Revolutionary Compact, High Pressure Hydrogen Gas Generation Platform for Chemists17.8.2018 11:00 | Pressemelding
Improves safety, expands chemistry, saves lives. BUDAPEST, Hungary and BOSTON, Aug. 17, 2018 (GLOBE NEWSWIRE) -- ThalesNano Energy LLC today announced, at the 256th ACS conference (booth: 1615), the launch of the first in the series of revolutionary new gas generators, the H-Genie™. The H-Genie™ is a compact high pressure hydrogen generator designed to be used in any laboratory as a safer and simpler alternative to hydrogen cylinders. Capable of generating hydrogen at up to 1 NL/min and 100 bar (1450 psi), the system can help expand chemists’ limited hydrogenation chemistry capability by providing high purity hydrogen gas, on demand from water, to batch and flow reactors. Neal Langerman, Principal Scientist at Advanced Chemical Safety, comments: “The presence of cylinders of hydrogen raises the risk level of a lab. While the explosion or fire hazard can be mitigated with a gas cylinder cabinet, this takes precious floor space and does not eliminate the 1300 liters of flammable gas from
PayByPhone Supports Additional Languages16.8.2018 19:47 | Pressemelding
Drivers can now use the app in Spanish and Chinese VANCOUVER, British Columbia, Aug. 16, 2018 (GLOBE NEWSWIRE) -- Drivers who pay for their parking with the PayByPhone app can now use the app in Spanish, Traditional Chinese, and Simplified Chinese. Later this year, the leading mobile parking payment service will also be available in Punjabi. The support of multiple languages increases PayByPhone’s usability for its diverse consumer base, who are located across North America, Europe, and Australia. To gain access to the newly supported languages within PayByPhone, drivers can simply download the latest version of the app and set their iOS or Android device to their preferred language. “We’re excited to have expanded our language offerings beyond English and French,” said Barrie Arnold, Chief Commercial Officer, PayByPhone North America. “PayByPhone is available in many multicultural cities worldwide, and this update improves the app’s accessibility. PayByPhone has gained a global presen
Global Dairy Platform Announces Dairy Farmers of America CEO Rick Smith as New Board Chair16.8.2018 17:52 | Pressemelding
ROSEMONT, Ill., Aug. 16, 2018 (GLOBE NEWSWIRE) -- Global Dairy Platform (GDP), a pre-competitive collaboration of dairy sector organizations focused on encouraging the appropriate intake of nutrient-rich dairy foods and demonstrating the sector’s role in sustainable agriculture, today announced the appointment of Rick Smith, President and Chief Executive Officer of Dairy Farmers of America as Chair of the Board of Directors. “It is truly an honor to serve as Chair of GDP’s Board of Directors,” noted Mr. Smith. “We are facing global food and health challenges that need short and long-term solutions. The work of GDP creates an avenue for collaborative action that demonstrates dairy’s valuable contribution to global food systems, healthy diets and sustainable livelihoods.” Mr. Smith will serve on the board along with Fonterra Co-operative Group Chief Executive Officer Mr. Miles Hurrell; China Mengniu Dairy Company Executive Director and Chief Executive Officer Mr. Minfang (Jeffery) Lu; Ro
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom