January 14, 2016
2016 ADVANCED HLA TECHNICAL WORKSHOPDate: February 29 - March 4, 2016
Location: Palm Springs, CA
Join us for the Advanced HLA Technical Workshop, February 29 through March 4, 2016 at the Renaissance Palm Springs Hotel in Palm Springs, California. Marking 30 years since our first workshop, this event is an important milestone in our continuing effort to offer professionals practical information in the field of HLA and transplantation.
The workshop will bring together distinguished clinicians and scientists in the world-wide transplant community for a discussion on the importance of assessing patient risk in transplantation and strategies for knowledge-based HLA antibody identification. The workshop will also feature presentations from the winners of the HLA case study competition and presentations on the role of HLA antibodies and NGS in bone marrow transplantation. The competition winners will be announced on January 18th and will be posted on the event page.
One Lambda achieved an important milestone this year with the release of our NXType Next Generation Sequencing (NGS) assays and complete NGS workflow solution. Our complete NGS solution includes a multiplexed amplification kit for HLA genes, library and template preparation reagents, the proven Ion Torrent sequencing platform, and TypeStream™, our state-of-the-art data analysis software. We provide expert technical support for the complete NXType assay workflow, from sample amplification to final result.
The NXType NGS assay workflow offers several key benefits:
- Turnaround Time: Sample-to-Results in less than 3 days (standard 8 hour shift) or less than 24 hours (3 consecutive 8 hour shifts)
- Multiplexed Primer Design
- Short PCR Amplification Time
- Fast Sequencing (< 9 hours)
- Fast Data Processing
- Scalable Throughput: Sequence up to 48 samples per run
- Automated Analysis: Sequencing data automatically processed at end of each run
- TypeStream Software Plug-in
- True high-resolution: HLA typing in one pass
For additional videos, brochures, and information on our NXType, our NGS solution, view our news page.
LABSCREEN™ SINGLE ANTIGEN CLASS I SUPPLEMENT KITS WITH EXPANDED COVERAGE
LABScreen Single Antigen Supplement Kits complement our core LABScreen kits to create a comprehensive DSA monitoring panel, thereby reducing the number of assays needed to create a full patient profile.
With the release of Lot 2 of the LABScreen Single Antigen Class I Supplement Kit (LS1ASP01), we also offer something else our customers have been asking for — greater harmonization in coverage across our antibody screening product lines, including FlowPRA and LABScreen PRA. The new Class I Supplement kit now covers 54 alleles, including 20 new targets.
Also coming in Q2-2016 — an expanded LABScreen Class II Single Antigen Supplement Kit. The new Class II lot will include greater coverage of DRB1; DRB3,4,5; DQB1/DQA1 and DPB1/DPA1.
For more information regarding LABType Single Antigen Supplement assays view the product page.
LABTYPE™ XR AND CWD RUO
In recent years, the number of HLA alleles listed in the IMGT/HLA Database has increased, on average, by 29% a year. As of September 2015, it contained over 14,000 alleles (Source: IPD-IMGT/HLA). The rapid growth in the number of known alleles presents a significant challenge, requiring new probes with every nomenclature update to help resolve newly identified ambiguities. As the number of probes continues to grow, it is becoming increasingly difficult to manufacture updated LABType kits. This is particularly true of the HD products, which can now include over 850 probes.
LABType XR and CWD assays are built on the 500 bead regions available exclusively on the LABScan3D™. More bead regions and extended exon coverage make it much easier to improve typing resolution. The CWD assays are designed to resolve alleles as defined by the CWD catalog. The XR assays are designed for laboratories interested in increased resolution beyond CWD.
The CWD assays are designed to resolve alleles as defined by the CWD catalog. The XR assays are designed for laboratories interested in increased resolution beyond CWD.
Lot 4 of the LABType XR and CWD HLA -A, -B, and -DRB1 RUO kits were released earlier this year and are available for sale. The HLA-C locus kit is projected to be released in May 2016.
Table 2. LABType XR & CWD Release Schedule
|Product Name||No. Tests||Cat ID|
|LABType CWD Products|
|LABType CWD Class I A Locus Typing Test||20||RSOW1ATR|
|LABType CWD Class I B Locus Typing Test||20||RSOW1BTR|
|LABType CWD Class II DRB1 Typing Test||20||RSOW2B1TR|
|LABType CWD Class I A Locus Typing Test||100||RSSOW1AR|
|LABType CWD Class I B Locus Typing Test||100||RSSOW1BR|
|LABType CWD Class II DRB1 Typing Test||100||RSSOW2B1R|
|LABType XR Products|
|LABType XR Class I A Locus Typing Test||20||RSOX1ATR|
|LABType XR Class I B Locus Typing Test||20||RSOX1BTR|
|LABType XR Class II DRB1 Locus Typing Test||20||RSOX2B1TR|
|LABType XR Class I A Locus Typing Test||100||RSSOX1AR|
|LABType XR Class I B Locus Typing Test||100||RSSOX1BR|
|LABType XR Class II DRB1 Locus Typing Test||100||RSSOX2B1R|
|Available May 2016|
|C Locus Products|
|LABType CWD Class I C Locus Typing Test||20||RSOW1CTR|
|LABType CWD Class I C Locus Typing Test||100||RSSOW1CR|
|LABType XR Class I C Locus Typing Test||20||RSOX1CTR|
|LABType XR Class I C Locus Typing Test||100||RSSOX1CR|
Regulatory: LABType XR and CWD are Research Use Only (RUO) products.
For information on LABType XR and CWD assays view the product page.
HLA FUSION™ VERSION 3.5 AND HLA FUSION RESEARCH VERSION 3.5 NOW AVAILABLE
The HLA Fusion Version 3.5 Service Pack was released November 2015. This service pack corrects known defects and allows the importation of uTYPE reference files into the Fusion database for use with the source of ambiguity feature in LABType analysis.
HLA Fusion Research Version 3.5 Service Pack was also released in November. The new RUO software supports the import of uTYPE™ reference files and SeCore SBT data analysis and reporting.
Download the Software Release Notes to learn more about the new versions of HLA Fusion.
- HLA Fusion Release Notes Software, v3.5 Service Pack IVD Version
- HLA Fusion RESEARCH Release Notes Software, v3.5 Service Pack
Research Use Only (RUO) product in the United States and Canada.
UTYPE VERSION 7.1 SERVICE PACK
Don’t forget to upgrade your uTYPE software, if you haven’t already done so. When you do, you’ll find an enhanced user interface with better navigation, clearer marking of bases – even on initial instantiation, and more accurate match reporting. Data output has also improved, with better report documentation.
Contact your One Lambda representative for a free upgrade.
ALLSET™+ GOLD DNA WIPE TEST
One Lambda’s DNA Wipe Test kit is designed to detect amplified products from UniTray™, AllSet+ Gold, and SeCore™ product lines which may interfere with the accurate reporting of test samples. Starting December 17, the “wet” UniTray™ DNA Wipe Test (Cat No. 789991) will change to the “dry” AllSet+ Gold format.
Questions related to the dry format DNA Wipe Test can be directed to One Lambda Technical Support.
SECORE™ SBT CLASS I EXTENDED
Our new SeCore Class I Extended kits will soon be in production. We expect this enhanced product to be available during the first half of 2016.
Our goal is to make SeCore the best Class I resolution kit available on the market. The new Class I sequencing kits contain additional sequencing primers for A Locus (exons 1 and 5), B Locus (exons 1 and 5) and C Locus (exons 1, 5, 6, and 7), and are intended to resolve CWD alleles (as defined by the October 2012 Revised Guidance ASHI Standards D.18.104.22.168).
To ensure that you experience no interruption in service while we complete the development process, we will continue to build enough of the current product to meet demand. Also, since the enhanced product will have the same Catalog ID as the current product, there will be no change in the ordering process as we bring the enhanced product online.
For information on SeCore SBT products, view the product page.
ONE LAMBDA DEVELOPS A REAL-TIME HLA TYPING ASSAY
We are pleased to announce the development of a real-time PCR HLA typing assay. Our new kit will use TaqMan® probe technology to detect amplification of genomic DNA on a real-time PCR instrument. We chose TaqMan chemistry because of the many advantages if offers, including:
- Target specific amplification - Hybridization between probe and target is required to generate the fluorescent signal, resulting in greater assay specificity and lower signal-to-noise ratio.
- Multiplexing capability - TaqMan probes can be labeled with different reporter dyes, allowing for the amplification and detection of multiple, distinct sequences in a single reaction.
- Simple workflow - Change in the fluorescent signal for each channel and each well of the PCR tray is measured directly on the real-time PCR system, eliminating the need for gel electrophoresis and reducing assay labor and material costs.
The initial product offering will consist of a serological level resolution kit covering all HLA Class I (A, B, C) and Class II (DRB1, DRB345, DQA1, DQB1, DPA1, DPB1) loci. The RUO kit will be validated on multiple real-time instruments including the Viia™ 7, QuantStudio™ 6, and QuantStudio™ DX system. Data run files will be imported into HLA Fusion™ for analysis.
We are on track to release a Research Use Only kit in Q2-2016 and plans are in place to follow up with the release of CE-IVD and FDA (510k) cleared products. We will keep you updated on our progress.
As you know, we’ve been working on going green for some time now. The benefits of switching from the 15th Century technology of printing important information on paper to the 21st Century technology of immediate digital delivery are too good to delay any longer.
The biggest challenge in making this kind of transition is to make sure that we are transitioning to something better. That’s what we’ve been working on since our Go Green Initiative started in 2014. This effort has included:
- Making sure that user documentation is available on our website
- Making sure that customers know how to find the documents they need
We’re pleased to announce that we’re coming to the end of this process and expect to complete the transition to digital delivery of all product documentation by the end of Q1, 2016.
Last Updated: 2016.05.24 (for trademark usage)