Hear experts address the gaps and limitations of CGP by using innovative simplified genomic profiling solutions that work for challenging samples not analyzable by CGP. Aspyre is a breakthrough technology that allows detection of DNA- and RNA-based biomarkers for all guideline-recommended genes associated with first-line NSCLC in a rapid turnaround time with exceptional sensitivity. In this webinar, you will learn how to:
Watch the webinar on demand below.
L.G. is a 71-year-old retired accountant who began experiencing symptoms associated with lung cancer, including shortness of breath and persistent cough. Concerned about his symptoms, he sought medical help from his primary care physician, who noted a large pleural effusion and pleural nodularity by imaging. A pleural fluid sample was aspirated, and a cell block was made; however, it was deemed insufficient for molecular studies due to low cellularity. Histology and immunohistochemistry analysis of the cell block were consistent with lung cancer (non-small cell carcinoma). A ctDNA test detected a TP53 variant at low variant allele frequencies, indicating a low tumor fraction and reducing the likelihood of identifying actionable mutations.
B.B., a 62-year-old piano teacher and avid hiker, began experiencing symptoms associated with lung cancer, including sudden shortness of breath and a persistent cough. Concerned, she sought medical help from a pulmonologist referred by her primary care physician. She was found to have a large pleural effusion, and her pulmonologist aspirated 40 mL of fluid, which was sent to pathology. A cell block was prepared, and histology and immunohistochemistry analyses of the cell block confirmed non-small cell lung cancer (NSCLC) with 15% tumor content, making it adequate for molecular testing.
Familiar with the benefits of targeted therapy, her pulmonologist ordered genomic testing with a large next-generation sequencing (NGS) panel to increase the likelihood of identifying an actionable variant. However, after 12 days, the NGS testing was reported as failed due to quantity not sufficient (QNS).
With more than 25 FDA approved therapies that target genomic mutations, treatment options for patients with non-small cell lung cancer (NSCLC) have improved considerably in the last 20 years. These target therapies dramatically improve clinical outcomes and save lives, but only when biomarker testing is performed to identify the genomic drivers that underlie each patient’s tumor.
A new study from Biofidelity is examining how its Aspyre technology can bridge the gaps in clinical care that prevent early-stage NSCLC patients from receiving molecular profiling and, as a result, highly effective targeted therapies.
“Advancing genomic testing for early-stage resectable NSCLC patients is crucial, and this study offers two opportunities: additional research about actionable mutations in this population and the assessment of a new platform with the potential to improve patient care,” said Dr. Shetal Patel from the University of North Carolina.
Read on to see how you can join this study and help expand testing options for Early Stage NSCLC.
Patients with resectable stage IB-IIIA, IIIB (T3, N2) NSCLC are usually only offered testing for ALK and EGFR mutations to determine their eligibility for neoadjuvant therapy. However, data suggests these early-stage patients may harbor additional actionable mutations. In fact, the International Association for the Study of Lung Cancer now “highly encourages” biomarker testing for oncogenic drivers other than EGFR and ALK alterations in patients with early-stage disease.1
In this new study, researchers will use the highly sensitive Aspyre Clinical Test for Lung tissue assay to identify additional actionable mutations in this patient population, offering a unique opportunity to gather data in a timely and cost-effective manner. The information may then be used to design future definitive clinical trials that aim to expand the list of actionable genomic alterations for this patient population, which could make targeted treatment options available to a larger group of patients.
“Ultimately, the results of this study can be used in future studies that will empower us to tailor treatments more precisely, improve outcomes and enhance the quality of life for patients with early-stage NSCLC,” Dr. Patel continued.
Aspyre Clinical Test for Lung has the potential to improve on the existing gaps in clinical care for early-stage NSCLC patients2. These gaps exist due to a number of limitations with next generation sequencing (NGS) assays, the current standard for molecular profiling.
This study will measure the time to genomic result availability of Aspyre Clinical Test for Lung, which is currently advertised as 48 hours. In contrast, NGS testing for EGFR mutations and ALK rearrangements typically have a TAT of 10 business days following receipt of the sample, often resulting in delayed clinical decision-making.
Tissue biopsies from early-stage patients are usually small in size. NGS assays have strict input requirements, often resulting in nearly 15% of these tissue samples untested due to insufficient quantity3. NGS is also sensitive to sample quality, with up to 25% of tissue samples failing assay quality control (QC)2,3,4. Aspyre Clinical Test for Lung has less stringent sample input requirements, with evidence that Aspyre Clinical Test for Lung can handle low quality samples in addition to other sample preparation types generally not amenable to NGS sequencing5.
NGS is comprehensive genomic testing that produces far more information beyond the small number of actionable mutations that are potentially present in early-stage NSCLC, making such broad-based testing unreasonably expensive. If you are interested in participating in this important research and subsequent publication, or would like more information, email e.shapiro@biofidelity.com. A full study synopsis can be found here.
See the workflow for Aspyre Lung in the video below.
See the workflow for Aspyre Clinical Test in the video below.
A straightforward, 4-step workflow on existing qPCR platforms. No need to invest in expensive hardware, data handling, or bioinformatics.
100% specificity, with the ability to consistently generate results from poor quality samples.
No need for complex bioinformatics. Biofidelity provides fast, simple cloud-based software at no additional cost.
Aspyre Lung Reagents can provide results in hours, enabling rapid input into NSCLC research.
With simple integration into your laboratory, Aspyre Lung Reagents enable lightning-fast analysis on samples you control.
Simultaneously analyze DNA & RNA from tissue or blood, maximizing the opportunity to identify mutations and fusions, while avoiding the time and expense of running separate assays or missing fusion positive samples.
98% of results provided within 2 days vs. 10-14 days with NGS, enabling earlier treatment decisions.
25-40% of lung cancer tissue samples fail NGS. Aspyre provides actionable clinical information from samples deemed to be insufficient quantity (QNS) or failed NGS QC. Challenging samples include pleural effusions, fine needle aspirates and others.1
Aspyre is more sensitive than both NGS and single-gene PCR tests, providing a greater likelihood of detecting an actionable variant.
Can be used on either blood or tissue samples with tumor content as low as 10%. Reflex option to blood if needed.
The Aspyre Clinical Test for Lung detects somatic mutations from DNA, and gene fusions directly from RNA maximizing the opportunity to identify mutations and fusions, while avoiding the additional time and expense of running separate assays.
The Aspyre Clinical Test for Lung has demonstrated successful results in 98% of samples that failed NGS due to QC failure.2
Targeted therapies dramatically improve clinical outcomes and save lives—but only when genomic testing is performed first to identify the genomic drivers that underlie each patient’s tumor. The benefits of this precision medicine approach are particularly acute in non-small cell lung cancer (NSCLC), in which there are more than 25 FDA approved therapies that target genomic mutations. More than 50% of patients harbor these alterations and can benefit from targeted treatment.
“You want testing in all patients up front, because you want to match patients to the best possible therapy,” explains Joshua K. Sabari, MD, thoracic medical oncologist at NYU Langone Health’s Perlmutter Cancer Center in New York, in a recent roundtable discussion published in Targeted Oncology.
However, the most widely-used testing method of genomic testing – Next Generation Sequencing (NGS) – remains complex to implement and costly to run, suffers from high failure rates, and may take weeks to return results.
Because of this, and despite the huge potential for improved clinical outcomes with genomic testing and targeted therapy, “many patients with non-small cell lung cancer do not receive guideline-recommended, biomarker-directed therapy,” reports a recent paper in Histopathology. One reason is that genomic testing isn’t available to all patients. In one study, published in 2022 in JCO Precision Oncology, nearly half—49.7%—of 500,000 patients with advanced NSCLC failed to receive biomarker testing, which it called “a cornerstone of personalized medicine in cancer care.” Moreover, almost one third—29.2%—of those who do get biomarker testing still were not given the appropriate treatments, in part because of issues with the testing methods.
The failure to bring targeted therapies to the majority of NSCLC patients is a major problem in today’s healthcare system. Solving it requires fast access to critical biomarker data, in a format that overcomes the limitations of current approaches, and that can be implemented straightforwardly in labs across the nation. Thankfully, this is now possible.
Broad molecular profiling of tissue remains the gold standard in NSCLC, and the recommendation of standard of care guidelines. Until recently, the only solution for this has been NGS. However, despite being a powerful tool, NGS has serious limitations in clinical practice.
NGS test failure is a major challenge, with as many as 25% of samples failing NGS due to quality control (QC) issues. Moreover, all parts of tumors are not the same, so small samples may not capture the full genomic diversity of the tumor, thus missing key mutations that could guide therapy.
For accurate and reliable results, NGS requires a sufficient amount of DNA, which may not be present in many biopsy samples. One study found that up to 30% of NSCLC samples are classified as “quantity not sufficient” (QNS).1 “This is a major barrier to getting testing done,” said Nathan Pennell, MD, PhD, Medical Oncologist and Co-Director of the Lung Cancer Program at Cleveland Clinic, in a recent Cancer Advances podcast. This problem, ironically, has been worsened by advances in robotic surgery which are resulting in more samples being collected as fine needle aspirates (FNAs). These samples are typically much smaller than standard core needle biopsies, and are much more challenging to analyze. “In too many cases, pathologists like myself have to deliver the bad news to oncologists that the biopsy samples they sent us don’t contain enough genomic material for reliable sequencing,” says molecular pathologist and Consultant Lab Director Dr. Shari Brown.
Even with high-quality samples, NGS takes time, with an average turnaround of 21 days. This is a serious problem when most lung cancer patients are diagnosed at Stage III or Stage IV and need to start treatment as quickly as possible. This problem gets worse when the initial biopsy sample is insufficient or of poor quality, requiring a repeat procedure that can be painful and challenging, particularly in patients with advanced disease or those in poor condition.
NGS is costly, both in terms of the price—an average of $3,000 to $5,000 per sample—and the emotional toll on patients as they are forced to wait weeks before they can begin treatment.
Now, however, there is a biomarker testing approach that solves all of these challenges. Called Aspyre Clinical Test for Lung, it accurately and rapidly analyzes all NCCN guideline recommended genes for NSCLC. It generates results in just two days, at a small fraction of the cost of NGS, enabling patients to get the right treatment for their individual tumors within days of diagnosis, not weeks.
Equally important, research shows that Aspyre Clinical Test for Lung solves quantity and quality issues. In one recent study, Biofidelity scientists reexamined commercially biobanked specimens from NSCLC patients that had failed quality control (QC) for NGS. The results of this study were accepted as a late breaking poster presentation at the AACR Annual Meeting 2024 in San Diego, California, and will be published in the online Proceedings of the AACR.
Aspyre Clinical Test for Lung is transformative for patients, enabling the rapid and accurate identification of actionable genomic mutations and fast, confident treatment decisions. It can be used both as a cost-effective first-line testing option, instead of NGS, or as a salvage method for testing samples that failed NGS because of insufficient DNA quantities or quality control issues. Aspyre Clinical Test for Lung thus has the potential to enable all patients to benefit from today’s highly effective targeted therapies.
1. Clinical Next-Generation Sequencing in Patients with Non-Small Cell Lung Cancer, Ian S. Hagemann, et.al, Original Article, Cancer, February 15, 2015. https://doi.org/10.1002/cncr.29089
ISO 13485 is an internationally recognized standard that sets out the requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Our certificate has been awarded for the design and development of reagents and consumables for use with in vitro diagnostic assays for molecular testing.
“We are thrilled to have achieved ISO 13485 certification,” said Barnaby Balmforth, PhD, Biofidelity Co-founder and CEO. “This certification is a testament to our team’s continued hard work and our commitment to providing the highest quality products to our customers.”
“Customers can be confident that our reagents and consumables are designed and developed in an environment of quality and improvement,” said Simon Knight, Biofidelity Director of Quality. “Receiving ISO 13485 certification is a tremendous stamp of approval for our Quality Management System, and provides a great platform to move us forward as the scope of certification expands over time.”
View the certificate here.
Biofidelity is a rapidly growing commercial-stage genomic technology company dedicated to bringing the benefits of precision medicine to patients around the world.
Aspyre®, the first application of our novel molecular biology technology platform, makes genomic analysis simpler, faster, and more efficient. With the ability to harness existing instrumentation commonplace in laboratories worldwide, Aspyre provides straightforward, cost-effective access to the vital information needed for accurate targeting and monitoring of cancer treatment.
Founded in 2019, Biofidelity is comprised of scientists, engineers, physicians and commercial experts dedicated to making genomics globally accessible. For more information, please visit biofidelity.com and connect with us on LinkedIn and Twitter.