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AccuGenomics: A Precision Diagnostics Company That Enables Accurate and Standardized Molecular Tests To Discover The True Underlying Biology From Next-Generation Sequencing

AccuGenomics, Inc | Nick Lazaridis
AccuGenomics, Inc | Nick Lazaridis

Waking up one morning and discovering that the world is hit by a pandemic virus can be breathtaking, but stepping back one must recognize the impressive ability of nature; with a long single-stranded molecule replicating inside the human genomic system, to put the world in perils of global lockdown.

Towards understanding the significance of genomic research, and perhaps partially attributed to increased social awareness from Covid-19, molecular diagnostics has been elevated and highlighted in society and is now more widely recognized and understood by those outside the core of the industry. Driving this change, many companies have facilitated groundbreaking clinical solutions while fostering an era of the scientific revolution. The trailblazing such entrepreneurial spirit that transforms the world for the better, AccuGenomics is exemplifying the true meaning of “technology leadership.”

As a clinical genomics leader, the company is positioning its gold-standard NGS standardization technology with the goal of helping millions with more accurate healthcare insights. Standing as the guiding light on the transformational path of AccuGenomics is company President Nick Lazaridis, Ph.D.

Realizing the technological marvels of the company, we at Insights Care met Nick to learn more about AccuGenomics’ present solutions and its future roadmap ahead.

Please go through the interview highlights:

Please brief our audience about your company, its USPs, and how it is currently positioned as a reliable firm in the healthcare sector.

AccuGenomics’s mission is to improve the accuracy and performance of clinical sequencing testing for better patient outcomes. The rapid pace of innovation in NGS diagnostics continues to push the limits of detection for low-abundance biomarkers, increasing the need to demonstrate the analytical performance of Companion Diagnostic (CDx) tests for patients and healthcare providers. We create internal standards for targeted NGS assays that reduce uncertainty and give clinicians and patients the accuracy in data to make confident medical decisions by eliminating false positive and false negative results, allowing the true underlying biology to be seen.

AccuGenomics has developed and commercialized technology solutions that enable test developers and implementers to demonstrate the highest performance levels TM of their sequencing assays. SNAQ -SEQ (Standardized Nucleic Acid Quantification for Sequencing) enables a host of highly sensitive NGS applications that improve variant detection in liquid biopsy, SARS-CoV-2 pathogen screening, and rapid adventitious agent detection in cell therapy manufacturing.

Nick, can you elaborate more on the solutions and services provided by AccuGenomics.

We design and manufacture internal spikes in standards that enable accurate detection of low abundance biomarkers from liquid biopsy or other sample types (can be any target, any platform, and any sample type). We improve the true limit of detection (LOD) for NGS assays so even rare variants can be identified so that the molecular markers of cancer can be detected earlier, even from liquid biopsy samples. These internal standards provide improvements across a number of aspects with NGS testing:

  • improve accuracy and enables the measurement of true LOD, which leads to better patient outcomes
  • are designed to be biochemically identical to the variant/target of interest; internal standards eliminate false positives and false negatives which improves the accuracy of all targeted NGS assay panels
  • are spiked into each sample at known concentrations during sample extraction, and co-process and co-vary with the target of interest, providing a perfect QC workflow
  • provides gold-standard reporting to pathologists as copies of variant/ml of plasma

We’re a disruptive precision diagnostics technology company that makes tools (assay-specific custom internal standards) that precisely quantify biology to power molecular diagnostic tests to be more accurate, standardized and harmonized, even across platforms and decentralized testing sites. The ability to improve sensitivity without a loss of specificity is critical in NGS testing and diagnosis, and these improvements are required to correctly call additional true positives with low abundance (these can be incorrectly called as false negatives if using pre-defined threshold algorithms provided from Dx test makers). The use of internal synthetic standards that biochemically mimic the variant of interest can provide a direct orthogonal measurement to determine a target-specific LOD for each sample, effectively tuning the detection limit to each sample.

With our collaborators, we have demonstrated an increase of 3-5-fold better sensitivity with targeted NGS panels, along with the elimination of false positives and false negatives that would otherwise lead to inaccurate variant calls and patient treatments. The use of internal spike in standards has a differentiated positive impact on precision medicine programs, and some of our pharma partners are finding the strong value of the technology for transcript abundance measurements.

We partner with labs that run NGS tests and make their tests more accurate and clinically relevant. Our business model is simple; design and manufacture client-specified internal spike in standards that improve targeted NGS tests, and provide them at scale and at a price point that enables adoption across applications.

Being an experienced leader, share your opinion on how the adoption of modern technologies and platforms has impacted the diagnostics space and how is your company riding the technology wave?

The SARS-CoV-2 pandemic has widely opened the market to address the unique needs of our clients when it comes to sequencing testing. We have been able to develop multiple internal standards for all currently identified SARS-CoV-2 variants for multiple sequencing methods and platforms, and have advanced this evolving landscape of SARS-CoV-2 NGS testing in parallel to the adoption of our technology with our clients focused on oncology clinical tests.

What would be your advice to budding entrepreneurs who aspire to venture into the healthcare space?

Self-belief and hard work are always good formulas for success. Surround themselves with other entrepreneurs that can provide great coaching to venture out their ideas in the healthcare space. Be flexible with their venture and adapt to market unmet needs, and identify and execute a strategy that addresses those needs.

How do you envision scaling your organization’s operations and offerings in 2022 and beyond?

Leveraging our grant awards from USAir Force and NIIMBL will bring new opportunities to adapt our technology to clinical sequencing testing. A focus on our client’s precision medicine unmet needs on sequencing methods to detect minimum residual disease (MRD) will give us the opportunity to become the leader in quantitative sequencing testing. These new opportunities will help us add headcount to address our internal needs in designing and manufacturing standards, and also enable adding additional support for sales and marketing.

Please give us a few testimonials of your clients/customers and a list of awards/recognitions that accurately highlight your organization’s position in the market.

Most of our clients operate under CDA so we cannot report their results. We can say that there is a lot of excitement when we show them how many false positives and false negatives we eliminate from their NGS methods. In addition to our announced grants from the USAF and NIIMBL, we’ve also participated in the FDASEQC consortium and at the NC Bioneer venture challenge. Of commercial importance, we are actively working with numerous clients that include pharmaceutical, CRO, diagnostic test manufacturers, and some of the leading academic institutions.

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