Company Plans Commercial Operations in 2021
Murrieta Genomics, the launchpad for genomic sequencing startups, has announced that simplSEQ, an incubator company, has completed its seed round funding, having received $2 million in total. Funds are to be used to validate the company’s novel sample preparation technology with external labs, further protect its patent-pending intellectual property and bring the first products to market.
“This is the amount we targeted to get to revenue generation,” stated John Powers, CEO of simplSEQ. “Our first product is a kit for the purification and isolation of nucleic acids from plasma that we believe will transform the genomic industry.”
Powers went on to explain that simplSEQ is initially focused on Nucleic Acid purification and Targeted Assays. The first product is designed to allow labs to isolate and purify virtually all DNA and RNA from biological samples in a completely different way than currently used. The company believes that its proprietary process will be a significant improvement over the existing conventions.
According to simplSEQ’s Chief Science Officer, Brandon Young, “My years at the bench led to a growing frustration with the status quo, accepting products with known issues and increasing complexity of sample preparation and I knew there had to be a better way. simplSEQ’s patent-pending approach eliminates error prone steps and improves turnaround time while reducing lab and labor costs.”
The first product being developed targets the fast-growing liquid biopsy segment. Targeted therapies based upon genomic biomarkers, disease recurrence monitoring, noninvasive pregnancy screening and early cancer screening are just a few of the areas this segment covers. Having a simple protocol that can improve cell free DNA yields while reducing PCR bias and eliminating hybridization and capture steps would be a significant advance. The simplSEQ process also co-purifies both DNA and RNA – enabling simultaneous downstream assays. In addition, no redesigned primers or informatics are needed.
“The clinical use of the cell free DNA has expanded since the initial use with non-invasive prenatal testing. The use of liquid biopsy in oncology has significantly increased since the first commercially available multigene liquid biopsy platform became available in 2014,” stated Dr. John Spinosa, Chief Medical Officer of simplSEQ. “Today several assays with cfDNA in oncology are commercially available and FDA-approved, and a subset of these assays are considered sufficient for treatment eligibility by insurance companies. We expect to see high growth in the applications of cfDNA as precision medicine advances.”
Another market segment simplSEQ intends to transform is the targeted next generation sequencing assay market. This rapidly expanding area is producing new applications in areas such as transplant surveillance, oncology, rare diseases, population genetics and pathogen detection.
“Our process enables improved targeted sequencing by eliminating the need for ligation and reducing GC content bias. We only need a single PCR step, no capture steps and there are no complicated high temperature wash steps. This will eliminate the need for highly trained lab personnel while reducing labor and sequencing costs. Lab turnaround times will be significantly improved and by eliminating steps that may lead to errors, the labs should be able to improve data quality,” explained Young.
One feature that is unique to simplSEQ’s process is that the nucleic acids are covalently bound to a support structure as single strands. This enables complimentary copies of each strand to be made and eluted off. The eluted strands can then be used for testing. The original DNA or RNA remains bound to the solid support and can be reinterrogated.
“As a pathologist, I am acutely aware of how precious samples can be,” said Dr. Spinosa. “The ability to preserve the original nucleic acid material while assaying a sample may eliminate the need for second biopsies if further interrogation is needed. One can go back to the original isolated sample. Dealing with scarce samples and limited time is becoming a larger and larger issue in the pathology community. The ability to test a nucleic acid sample in multiple ways while preserving the original material would be a huge benefit. One can easily envision step-wise assays and the potential of creating a biobank that patients can return to as their care may dictate.”
The company is currently in discussions with industry-leading organizations that have expressed a desire to evaluate the new technology and will thus provide validation on the data that has been generated internally by the company. Upon receiving data and feedback from these organizations, simplSEQ is prepared to go to market.
“We already have manufacturing, fulfillment, delivery and billing in place,” stated Powers. “We will have the ability to scale rapidly, as these operations are being outsourced to leaders in their respective areas. We also believe that many of our larger future customers will want to license the technology for use in their applications. This funding marks a pivotal step in simplSEQ’s development.”
Murrieta Genomics CEO, Jay Goth, stated “This is a perfect example of the kind of genomic sequencing companies we want to launch from our incubator. We are looking for transformational companies that can make an impact in this nascent space. Our advisory board has been instrumental and even critical to the development of simplSEQ. I can tell you that without the entire MG team simplSEQ would not be where it is today.”