DURHAM, N.C.--(BUSINESS WIRE)--BioSkryb, Inc., a developer of genomic amplification technologies, today announced the commercial launch of ResolveDNATM products to accurately and uniformly reproduce genomes of single cells. The ResolveDNA product line incorporates novel primary template-directed amplification (PTA) technology, which captures more than 95% of the genomes of single cells to provide high-quality, scalable analysis of single-cell genomic heterogeneity. This proprietary technology will enable new insights into human disease at the cellular level. To hear more about the now commercially available ResolveDNA suite of products, visit BioSkryb’s virtual booth at ASHG 2020.
DURHAM, NC, Aug. 3, 2020 -- BioSkryb, Inc. ("BioSkryb"), a developer of genomic amplification technologies that deliver higher coverage and fidelity for gene sequencing, today announced that it has launched an Early Access Program (EAP) for researchers to test its proprietary genomic amplification technology (Primary Template-directed Amplification or PTA). Enrollment in the program secures dedicated workflow support to ensure their participants receive the highest quality results possible to enable their next discovery.
Single Cell Genome Sequencing Company BioSkryb and St. Jude Children’s Research Hospital Partner to Develop Clinical Diagnostic Solutions to Identify Resistant Cancer Cells as Patients Undergo Treatment
DURHAM, N.C., June 22, 2020 /PRNewswire/ -- BioSkryb, a developer of genomic amplification technologies that deliver higher coverage and fidelity for gene sequencing, today announced that it has entered into an exclusive worldwide licensing agreement with St. Jude Children's Research Hospital, the nation's leading hospital dedicated to understanding, treating and curing childhood cancer and other life-threatening diseases. BioSkryb will use St. Jude technology to develop a first-in-class clinical diagnostic solution to detect and define heterogeneous populations of cancer cells as patients undergo treatment.
BioSkryb and St. Jude previously established an exclusive licensing agreement for the research-based applications of the primary template-directed amplification technology (PTA).
"With this expanded licensing agreement, we hope to use this technology developed by scientists at St. Jude to generate diagnostic solutions that provide real insights to improve cancer treatments," said Jay West, PhD, CEO and Co-founder of BioSkryb.
With the expansion of the license, BioSkryb will initiate the process of developing diagnostic solutions that take advantage of the proprietary single cell-genomic amplification approach.
The company and their early access customers have demonstrated the superior performance of PTA compared to existing genome amplification technologies. These advancements are driving the early demand for the developed suite of research-use-only products, marketed as the ResolveDNA™ product line (formerly SkrybAmp). Basic and clinical research groups have been looking for a solution that provides the improved accuracy in genome sequencing that the ResolveDNA amplification system offers using low inputs of DNA and single cells.
"I am confident that the significantly improved accuracy of single-cell genome sequencing enabled by PTA will lead to a new generation of clinical diagnostics, providing much more detailed information on the genomic changes in a tumor than what is currently available with standard sequencing approaches," said Charles Gawad MD, PhD, Associate Professor at Stanford University, BioSkryb Co-founder and the inventor of the PTA technology while at St. Jude. "The ultimate goal of the cancer clinical diagnostic is to connect genetic variation in those single cancer cells to a phenotype, such as resistance to a specific drug—with the aim of translating that into an actionable diagnostic test that will guide higher resolution precision oncology and improved outcomes for our patients."
BioSkryb will initially focus on hematologic cancers, followed by the development of similar solutions for solid tumors.
Building better data
When asked about today’s most common uses of single-cell genotyping, Charles Gawad—a pediatric oncologist at Stanford University—said that preimplantation genetic diagnosis is one of the key applications. Here, genotyping of a cell from an embryo produced with in vitro fertilization helps clinicians test for genetic disorders before implanting an embryo.
In the near future, Gawad expects applications in other areas to become more frequent. One that he mentioned is cancer research, where single-cell genotyping could reveal “tumor heterogeneity or rare groups of cells that survive treatments.” He added that “sequencing the microbiome at single-cell resolution is an emerging area.” Gawad also pointed out applications in aging research and forensics. In his lab, Gawad and his colleagues explore new applications, like the off-target effects of CRISPR-driven gene editing and other uses. As an example, he said, “We can also measure the mutation rates after exposure to a mutagen to see how many mutations are induced in different cell types.”
The biggest challenge of single-cell genotyping, Gawad said, “is the quality of the data.” After amplifying a cell’s genome, he noted, “you can lose part of the original genome or get uneven amplification, where there’s good sequencing information from one region but not others.”
To help with this, Gawad and Jay West, a scientist and inventor, founded BioSkryb, which makes whole-genome amplification kits. Currently being assessed in an early access program, the company’s initial product will be available soon.
A mission in partnering
In applying single-cell genotyping to healthcare, teamwork might accelerate the impact, and some companies pursue such relationships. “Mission Bio has entered various partnerships with leading life science companies to support its global expansion efforts and further cancer research and therapeutic development through clinical trials,” said Darrin Crisitello, chief commercial officer at the company. “These partnerships empower researchers and clinicians to predict and prevent cancer with Mission Bio’s proprietary technology, the Tapestri Platform.” For example, Crisitello said, “Last year, Mission Bio partnered with LabCorp, marking the first global contract research organization to offer services on the Mission Bio Tapestri Platform.” As a result of this collaboration, this technology can be used in clinical trials and to develop new diagnostic tools.
Other partnerships push the Tapestri Platform into even more uses. As another example, Mission Bio developed a partnership with Onconova Therapeutics, a biopharmaceutical company discovering and developing products to treat cancer, focusing on myelodysplastic syndromes.
When asked about the main benefits of taking a partnership approach, Crisitello said, “Leveraging these partnerships, Mission Bio can focus on what matters most—helping our customers cure cancer.” Plus, Crisitello pointed out another benefit of partnerships: “Rather than vertically integrating its own distribution or manufacturing channels, Mission Bio can invest its resources in R&D and technological innovation.”
Mission Bio plans to continue its partnership approach. “In November of 2019, Mission Bio partnered with BioLegend, a global leader in antibody and reagent manufacturing, to expand into multi-omics,” Crisitello said. That partnership resulted in the co-development of “the first commercial solution for combined DNA and protein analysis at the single-cell level,” according to Crisitello. “The novel combination of phenotypic and genotypic data enables BioLegend’s customers to inform patient-specific therapeutic strategies.”
A reprogramming process
Instead of studying the DNA from a single cell, scientists can also examine the RNA. With RNA sequencing (RNA-seq), scientists can identify the genes that are being transcribed.
“We use a lot of transcriptomics,” said Vicki Moignard, senior scientist at Mogrify. “Of particular interest to us at the moment is how we can use this methodology to determine how introducing transgenes to cells influences their transcriptome and cell identity.”
Image: Sequencing the RNA from single cells can be used to reprogram many processes. Image courtesy of Mogrify.
From this work, Moignard and her colleagues hope to better “understand the heterogeneity of the cells we generate and how we can improve our reprogramming process.” That reprogramming could be used in many applications, including immuno-oncology. As an example, Mogrify said, “There have also been many studies using CRISPR screens to look at the impact of removing or activating genes on the transcriptome for cell-reprogramming studies, to understand regulatory networks controlling various cell states and responses to stimuli, and to look for synthetic lethality in cancer.”
So, working with RNA provides scientists with additional ways to study cancer and possibly develop new approaches to treatment.
For a biologist, exploring the DNA or RNA of a single cell opens opportunities for a lifetime of research. Likewise, the technology behind single-cell genotyping can extend lifetimes.
In discussing BioSkryb’s kits, Gawad said, “Our vision is that it ends up in the clinic.” He added, “We know there are rare populations of cells that cause relapse and cause some of my patients to not do well, and we want to provide tools to define the biology of those populations of cells and provide actionable insights for oncologists.”
From aging and oncology to exploring some of life’s most fundamental mechanisms, the ability to analyze the DNA in just one cell makes me wonder: What would Charles Darwin and Gregor Mendel think of this?
Hero image: Sequencing the DNA from a single cell can provide some of the most fundamental information in biology and medicine. Image courtesy of National Human Genome Research Institute.
DURHAM, February 24, 2020 -- BioSkryb, Inc., a developer of genomic amplification technologies that deliver higher coverage and fidelity for gene sequencing, today announced that it is partnering with Argonaut Manufacturing Services, a contract manufacturing organization (CMO) serving the life science and molecular diagnostics markets, to scale production of its genomic amplification system for the life science and clinical research markets. Under the terms of the agreement, Argonaut will manufacture and assemble kits and reagents for Bioskryb for use in its R&D, clinical research, and commercial systems effective the second quarter of 2020.
“Argonaut has a deeply experienced and energetic team, and they are true innovators in this space,” said Jay West, PhD, CEO of Bioskryb. “Argonaut’s capabilities, in terms of cost-efficiency, scale-up, and quality is what has attracted us to partner with them. We are thrilled to utilize Argonaut as a long-term partner to scale up our production to meet growing customer demand.”
“The team at Argonaut has extensive experience scaling up and producing kits for genomic applications and we are very excited to be working with BioSkryb to help accelerate these products to market,” said Wayne Woodard, CEO of Argonaut. “The regulated molecular diagnostics market remains the fastest growing segment of life sciences, and innovators like BioSkryb are leading the way. We are very proud to be supporting these game-changing companies. Genomics has shown great promise in fighting disease and advancing global health, and Argonaut is eager to support innovators like BioSkryb in this important mission.”
For more information about BioSkryb and its technology, please visit: https://bioskryb.com.
For more information about Argonaut’s manufacturing capabilities, please visit: https://argonautms.com
BioSkryb is a venture-backed developer of genomic amplification technologies based in Durham, North Carolina. Their proprietary Primary Template-directed Amplification (PTA) system delivers reproducible, high coverage breadth and uniformity for various low or ultra-low input sequencing applications. Its products support sequencing library generation produced from limiting samples that have undergone whole genome amplification, resulting in the highest quality genetic analyses available today. For more information, please visit: https://www.bioskryb.com/.
About Argonaut Manufacturing Services
Argonaut Manufacturing Services is a cGMP contract manufacturing organization dedicated to providing custom manufacturing and supply chain solutions for biopharmaceutical, life science, and molecular diagnostics companies worldwide. With state-of-the-art equipment, ISO 13485:2016 compliance, and FDA registration, Argonaut meets your regulatory requirements. Services include high-yield aseptic fill/finish, reagent formulation, filling, kitting, lyophilization, and analytical support. From diagnostics to drug products, Argonaut provides a wide range of flexible solutions for diverse outsourcing needs.
Jan 23, 2020 | Andrew P. Han
NEW YORK – A North Carolina startup is hoping to take genomic research to the single-cell level, with a new whole-genome amplification technology.
"I haven't done bulk RNA sequencing in probably five years," said Charles Gawad, cofounder of Durham, North Carolina-based BioSkryb (pronounced "bio-scribe") and a professor at Stanford University Medical School. "The richness of data is so much deeper. We can do the same thing for DNA."
BioSkryb is launching a line of sample preparation kits based on primary template-directed amplification (PTA) chemistry. The firm has exclusively licensed the patent-pending IP from St. Jude Children's Research Hospital, where Gawad developed it to research cancer genetic heterogeneity. The proprietary flavor of PTA, called SkrybAmp, offers up to 99 percent genome coverage and variant call rates of up to 90 percent at 30x coverage, Gawad said. For comparison, a 2017 study of whole-genome amplification (WGA) methods used in single-cell exome sequencing, from researchers at Sweden's Science for Life Laboratory, found that Ampli1 technology, an MDA-based approach, led to about 10 percent of variants called; while multiple annealing and looping-based amplification (MALBAC), another non-MDA method, led to 16 percent of variants called.
SkrybAmp chemistry is flexible, Gawad added, allowing for copy number and structural variant detection. "We can enrich for and capture any fraction of the genome we want," he said.
BioSkryb plans to initially go after the niche market of labs running MDA for single-cell DNA analysis with its SkrybAmp Single-Cell Kit, which will run 96 cells following fluorescence-activated cell sorting, CEO and Cofounder Jay West said.
Ultimately, the firm hopes to attract new people to the field. "We're really interested in enabling new discoveries," Gawad said. "Panels, by definition, are using targets you already know are important. We want people to discover new mutations and alterations that are not known." Beyond discovery, BioSkryb also has plans to make single-cell DNA sequencing a part of clinical practice.
Gawad got his start with single-cell DNA sequencing in 2012, when he joined the Stanford lab of single-cell sequencing pioneer Stephen Quake. "The challenge with DNA was the quality of the data you got," with MDA methods, Gawad said. "It was not sufficient to answer the biological questions we wanted to address."
MDA is plagued by a so-called "jackpotting effect," he explained. "Where you get priming, that part takes off and you cover a lot." His idea to resist that was to slow down the reaction speed with nucleotides designed to terminate products between 200 bases and a couple kilobases, so the regions that did not initially get priming could catch up.
Gawad started his own lab in 2015 at St. Jude's and used PTA to tackle questions about cancer heterogeneity. But he believed the WGA technology could prove powerful in several other areas where genomic differences between cells was important, including CRISPR off-target analysis, non-invasive preimplantation genetic diagnosis, rare disease diagnosis, and even microbiome research. After filing for patents in January 2018, he began talking with West, a former Fluidigm senior director of R&D, later that year. They cofounded BioSkryb in August 2018 and have linked up with private equity firm Anzu Partners, who led their $11.5 million seed funding round, announced earlier this month.
BioSkryb has 10 employees on site in Durham, with another 10 to 15 contractors. Anzu offers companies in its portfolio some services, including finance and human resources. Anzu's David Michael said his firm does this "to make it easier to scale. And it has worked well."
West said that BioSkryb has made "additional improvements" to PTA "with additional patents pending," but declined to discuss them. Gawad added that he felt SkrybAmp could be pushed to get even more variant calls and because it uses direct ligation, and barcodes could be incorporated into the products to increase throughput.
The SkrybAmp single-cell kit will be the company's first product, for use in the sequencing workflow ahead of standard library preparation. "We believe our library outputs are compatible with the range of sequencing technologies," West said, but the kit is configured for use with Illumina's platforms. The firm will also launch accessories to improve kit performance, such as magnetic plate technology to help with purification and bead cleanup kits.
With a 30-minute hands-on time and a thermal cycler as the only necessary equipment, SkrybAmp can compete with MDA or MALBAC for use in single-cell DNA sequencing, the firm said. "That's our most easily addressable market," Gawad said.
BioSkryb has begun disseminating SkrybAmp to about 15 key opinion leaders. The firm said participants signed confidentiality agreements and that none were able to discuss their experience with the single-cell kit. "Once we get data back, which we have, we'll begin an early-access program that is going to start quite soon," offering a 24-cell version of the kit, West said. "Definitely within the next month or two."
The single-cell DNA analysis market is small, with just a few companies offering either kits or platforms. Commercialized MDA-based WGA methods include Qiagen's Repli-g, Silicon Biosystems' Ampli1 WGA, and Rubicon Genomics' PicoPlex DNA-seq and Picoseq. 10x Genomics offers a Single-Cell CNV solution based on its Chromium system. And Mission Bio offers droplet-based, high-throughput, single-cell DNA analysis through its Tapestri platform.
But West said BioSkryb is "fundamentally different" from Mission Bio. "They're running targeted panels. We analyze the entire genome."
"In terms of our ability to create single-cell exomes, we don't really have a lot of competition. We're going to have an unfair advantage in this market space," he said.
That market space could one day include clinical applications, if the team's vision for SkrybAmp comes true.
"Cancer is much more complex than people realize," Gawad said. "Now we have the tools to detail that complexity. Our longer-term vision is those discoveries be useful clinically."