GlobeNewswire

Invivoscribe Releases the LymphoTrack Dx TRB Assay as CE-Marked IVD Kit, Completing the NGS Clonality Suite for the MiSeq Platform

Dela

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, IGKTRG, 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.

About 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.

CONTACT:
Kevin Dobyns 858-224-6600




This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
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

GlobeNewswire



Följ GlobeNewswire

Abonnera på våra pressmeddelanden.

Senaste pressmeddelandena från GlobeNewswire

Oboya signs a cooperation agreement with Gaia regarding biomaterials13.12.2018 11:41Pressmeddelande

Oboya Horticulture Industries AB (publ) ("Oboya") has signed an important and long-term cooperation agreement on environmentally friendly biomaterials with Gaia Biomaterials AB ("Gaia") in Helsingborg, Sweden. The agreement means that Oboya uses Gaias biomaterials for the production and development of environmentally friendly cultivation products for the cultivation industry. Oboya has been actively involved in innovation, environmental and sustainability issues in recent years, and our goal is to encourage environmental and sustainability in the cultivation industry by offering environmentally friendly cultivation products to our customers. Oboya believes that the use of biomaterials will be important for success in the conversion to a fossil-free cultivation industry worldwide. The cooperation agreement means that Oboya uses Gaias biomaterials in its production and that through Gaias expertise we can develop new environmentally friendly cultivation products. Gaias biomaterials are bi

Oboya tecknar ett samarbetsavtal med Gaia avseende biomaterial13.12.2018 11:41Pressmeddelande

Oboya Horticulture Industries AB (publ) ("Oboya") har tecknat ett viktigt och långsiktigt samarbetsavtal avseende miljövänligt biomaterial med Gaia Biomaterials AB ("Gaia") i Helsingborg, Sverige. Avtalet innebär att Oboya använder Gaias biomaterial för tillverkning och utveckling av miljövänliga odlingsprodukter till odlingsindustrin. Oboya har under de senaste åren arbetat aktivt med innovation, miljö- och hållbarhetsfrågor och vårt mål är att främja miljö och hållbarhet inom odlingsindustrin genom att erbjuda miljövänliga odlingsprodukter till våra kunder. Oboya anser att användningen av biomaterial kommer att vara viktigt för framgång i omställningen till en fossilfri odlingsindustri världen över. Samarbetsavtalet innebär att Oboya använder Gaias biomaterial i sin produktion och att vi genom Gaias kompetens kan utveckla nya miljövänliga odlingsprodukter. Gaias biomaterial är biologiskt nedbrytbart, komposterbart samt ger upp till 80 % lägre koldioxidutsläpp vid förbränning jämfört

Stillfront: Simutronics reclaims publishing services10.12.2018 14:11Pressmeddelande

PRESS RELEASE December 10, 2018 Simutronics reclaims the publishing services for SIEGE: Titan Wars globally except China Simutronics Corp, a studio within Stillfront Group AB, has ended a co-publishing agreement regarding the mobile game SIEGE: Titan Wars with New York based publishing partner Tilting Point. According to a new agreement, Tilting Point will continue to provide publishing services and market the game in China but Simutronics will run the publishing services and marketing globally from the Group going forward. Simutronics is a leading developer of online roleplaying and mobile games such as DragonRealms, GemStone IV and Lara Croft Relic Run, the latter with more than 23 million downloads. Tilting Point is a new-generation games partner that provides top development studios with expert resources, services, and operational support to optimize high quality live games for success. "I am very pleased to continue the partnership with Tilting Point for the Chinese market as this

Stillfront: Simutronics återtar förläggartjänster10.12.2018 14:11Pressmeddelande

PRESSMEDDELANDE 2018-12-10 Simutronics återtar förläggartjänster för SIEGE: Titan Wars globalt med undantag för Kina Simutronics, en studio inom Stillfront Group, har avslutat ett medförläggaravtal avseende mobilspelet SIEGE: Titan Wars med den New York-baserade förläggarpartnern Tilting Point. Enligt ett nytt avtal kommer Tilting Point fortsatt att tillhandahålla förläggartjänster och marknadsföring av spelet i Kina men på global nivå kommer Simutronics att ansvara för förläggartjänster och marknadsföring av spelet från gruppen. Simutronics är en ledande utvecklare av rollspel och mobila spel som till exempel DragonRealms, GemStone IV och Lara Croft Relic Run, den sistnämnda med mer än 23 miljoner nedladdningar. Tilting Point är den nya generationens spelbolagspartner som förser ledande utvecklingsstudios med expertis, tjänster och operationell support för att optimera högkvalitativa livespel framgångsrikt. "Jag är mycket nöjd över det fortsatta partnerskapet med Tilting Point för den

Karolinska Development's portfolio company Aprea Therapeutics presents continued positive results from a Phase Ib/II study of APR 2462.12.2018 18:00Pressmeddelande

STOCKHOLM, December 2, 2018. Karolinska Development's portfolio company Aprea Therapeutics today presented positive clinical results for its drug candidate APR 246 at the 2018 American Society of Hematology (ASH) Annual Meeting in San Diego, US. An Overall Response Rate of 95% and a Complete Remission (CR) rate of 70% were achieved in an ongoing Phase I/II combination study of APR 246 and azacitidine (AZA) for the treatment of TP53 mutated Myelodysplastic Syndrome (MDS). No dose-limiting toxicities have been observed. Based on these encouraging data, Aprea intends to progress APR 246 into a Phase III study in the near future. The results presented at the ASH meeting is based on 20 patients with TP53 mutated MDS. The overall response rate was 95%, and 14 (70%) patients achieved a complete remission at data cutoff. These findings were accompanied by a deep molecular remission in the majority of patients as assessed by serial TP53 analysis. No dose-limiting toxicities have been experience

Karolinska Development's portfolio company Aprea Therapeutics presents continued positive results from a Phase Ib/II study of APR 2462.12.2018 18:00Pressmeddelande

STOCKHOLM, December 2, 2018. Karolinska Development's portfolio company Aprea Therapeutics today presented positive clinical results for its drug candidate APR 246 at the 2018 American Society of Hematology (ASH) Annual Meeting in San Diego, US. An Overall Response Rate of 95% and a Complete Remission (CR) rate of 70% were achieved in an ongoing Phase I/II combination study of APR 246 and azacitidine (AZA) for the treatment of TP53 mutated Myelodysplastic Syndrome (MDS). No dose-limiting toxicities have been observed. Based on these encouraging data, Aprea intends to progress APR 246 into a Phase III study in the near future. The results presented at the ASH meeting is based on 20 patients with TP53 mutated MDS. The overall response rate was 95%, and 14 (70%) patients achieved a complete remission at data cutoff. These findings were accompanied by a deep molecular remission in the majority of patients as assessed by serial TP53 analysis. No dose-limiting toxicities have been experience

I vårt pressrum kan du läsa de senaste pressmeddelandena, få tillgång till pressmaterial och hitta kontaktinformation.

Besök vårt pressrum