Minimal residual disease (MRD) testing identifies the presence of small amounts of cancer cells that may remain after treatment, such as surgery, potentially leading to recurrence. These residual or recurrent cancer cells are identified through a noninvasive liquid biopsy (blood) test that detects the presence of circulating tumor DNA (ctDNA)—fragments of DNA that are released by tumor cells into the bloodstream. This information can be used for the following purposes: To determine a patient’s risk of recurrence in the absence of additional treatment To identify patients who are more likely to benefit from additional treatment To monitor a patient’s disease while on treatment To identify patients with disease recurrence following definitive treatment

How can MRD testing benefit patients?

MRD testing can detect residual, recurrent, or resistant cancer cells earlier than traditional detection methods. Earlier detection enables treatment decisions to be made when the tumor burden is low, increasing the chances for successful treatment.

How does Haystack MRD work?

Haystack MRD is a liquid biopsy (blood) test that uses a tumor-informed approach to maximize the sensitivity and specificity of circulating tumor DNA (ctDNA) detection. Haystack MRD testing begins with whole-exome sequencing (WES) of a patient’s tumor tissue and a matched normal blood sample to identify patient-specific somatic mutations. A personalized mutation panel is then designed for each patient, and a next-generation sequencing (NGS)-based assay is performed to detect and monitor ctDNA in plasma to identify the presence of residual, recurrent, or resistant disease.

Why choose ctDNA-based MRD testing?

Searching for and analyzing ctDNA is a noninvasive way to test for residual disease. A liquid (blood-based) biopsy can detect the presence of tumor cells up to 6 months earlier than imaging, increasing the likelihood that a therapeutic intervention will be successful.

Why choose Haystack MRD over other liquid biopsy MRD tests?

Haystack MRD is the only test specifically built with the sensitivity to accurately detect MRD in patients with early-stage disease. Haystack MRD detects ultralow levels of ctDNA to provide insights at critical moments for important treatment decisions, to accurately monitor treatment response and disease clearance, and to detect the earliest stages of disease relapse. Importantly, Haystack MRD’s superior performance ensures confidence in results and enables an early window of opportunity when clinical management decisions can have the greatest impact on patient outcomes. Haystack MRD can greatly accelerate clinical development by enriching for a greater number of patients with residual disease than other tests can. By providing ultrahigh sensitivity, Haystack MRD is capable of identifying a larger pool of MRD-positive patients, which can significantly impact enrollment and time to trial completion. In addition, Haystack MRD can be used for monitoring treatment response for clinical investigations, facilitating early determination of treatment efficacy. Haystack MRD will be broadly available, as patient samples can be provided to any of the more than 2,200 Quest Diagnostics Patient Service Centers across the US. These key features differentiate Haystack MRD from other tests: Ultrahigh sensitivity for detection of MRD, therapeutic response monitoring, and surveillance for cancer recurrence —Haystack Duo™, the chemistry behind Haystack MRD, was developed to significantly reduce background noise to detect even the least abundant ctDNA molecules in blood, delivering industry-leading sensitivity with the ability to detect one mutant DNA molecule in a million normal DNA molecules. As a result, extremely low levels of ctDNA can be called with confidence. Tumor-informed, personalized assay —A personalized assay is developed based on “ground-truth” mutations that are identified via whole-exome sequencing (WES) in the original tumor sample. Built on decades of ctDNA clinical technology development —Haystack MRD was built from the ground up by pioneers in liquid biopsy technology to overcome the unique challenges of ctDNA detection in the MRD setting and does not rely on methods adapted from other intended uses such as NIPT (noninvasive prenatal testing) and tumor profiling of metastatic cancers. Optimal number of mutations tracked —With other tests, every mutation tracked increases the level of background signal that the test must deal with to try to discern tumor signal. Haystack’s proprietary technology effectively eliminates the background signal so that mutations are accurately tracked and the optimal number of mutations can be included in each patient’s test panel. Demonstrated clinical utility —Haystack MRD is the first method to generate interventional data supporting the clinical utility of using ctDNA MRD testing to guide adjuvant therapy decisions (see “What is the DYNAMIC study?” below).

Is Haystack MRD covered by patients’ insurance?

We are working with Centers for Medicare & Medicaid Services (CMS) and private insurance companies to acquire coverage for Haystack MRD upon commercial launch.

Can Haystack MRD be used as a clinical development tool?

Yes, our platform can be used to help stratify patients for enrollment in adjuvant-setting and second-line therapy trials and to monitor therapeutic efficacy, providing significant time and cost savings.

When will Haystack MRD be commercially available?

The test will launch commercially in 2024. For information about potential early access partnerships, contact our commercial team at info@haystackoncology.com.

What sample types are appropriate for Haystack MRD?

To design the initial, personalized assay, Haystack MRD requires a formalin-fixed, paraffin-embedded tumor sample (or in some cases, a biopsy sample) and a blood draw. For monitoring MRD status at all future time points, a blood draw is required.

How much tissue is required to create the personalized test? Can you use a biopsy, or does it need to be from a resection?

To build the personalized MRD panel, a tissue sample of at least 25 mm 2 of surface area and 50 µm of depth are required. Biopsies are accepted, but they may have a higher failure rate if they yield fewer non-necrotic tumor cells. A block with 4–5 needle biopsies will typically yield enough DNA for successful sequencing.

How is the tumor sample obtained?

The tumor sample is obtained surgically (typically when a tumor is removed surgically from the body with curative intent) and should be formalin-fixed and paraffin-embedded. When Haystack MRD is ordered, we will work with the pathology lab to obtain the tumor tissue.

What is the turnaround time for the test results?

Results for an initial order can take up to 4 weeks, which includes time to build a personalized test for new patients. Any subsequent test results will be provided within 5–7 days after the order is placed.

How many mutations does Haystack MRD track?

Our proprietary technology effectively eliminates the background signal so that the optimal number of mutations can be included in each patient’s test panel. Haystack MRD tracks up to 50 mutations, prioritizing truncal somatic mutations.

Is your lab CLIA certified?

Yes, all Haystack MRD testing is done in a CLIA-certified lab.

Can I use the whole-exome sequencing (WES) results for patient management decisions?

A whole-exome sequencing report will not be available. The data from WES will be fed into Haystack MRD’s mutation-selecting algorithm to create a personalized MRD test.

My patient’s tumor sample was inadequate for (or failed) WES—now what?

If an additional paraffin block from the patient’s tumor is available, we can attempt to rescue failed tumor whole-exome sequencing (WES). To reduce the risk of failures, we ask that the block with the highest tumor cellularity and lowest amount of necrotic tissue is selected.

What are cfDNA and ctDNA?

Cell-free DNA (cfDNA) is released into the bloodstream from various cells in the body, especially those of the hematopoietic system. If a tumor is present in the body, cells from the tumor may also release DNA into the bloodstream. This circulating tumor DNA (ctDNA) typically makes up a small proportion of the total cfDNA in the bloodstream.

What is Haystack Duo™?

Haystack Duo is the name of the chemistry that powers Haystack MRD. While the details of the chemistry are proprietary, Duo is a highly optimized version of Safe-SeqS chemistry, which was employed in the DYNAMIC study (see “What is the DYNAMIC study?” below). Duo is the only chemistry that was purpose-built and specifically optimized to detect the ultralow ctDNA levels that are found in postsurgical patients with residual or recurrent disease.

What is the DYNAMIC study?

The DYNAMIC study, reported at the 2022 American Society of Clinical Oncology (ASCO) meeting and published in the New England Journal of Medicine , is the first prospective, interventional, randomized trial to demonstrate the clinical utility of a ctDNA-guided treatment strategy. The study evaluated the potential of ctDNA-based MRD testing to guide adjuvant therapy decisions in stage II colorectal cancer patients who had undergone curative-intent surgery. The results of the study showed that a ctDNA-guided treatment strategy led to 50% fewer patients receiving chemotherapy as compared to patients treated based on standard-of-care clinicopathological risk factors, with no reduction in 2-year recurrence-free survival. Read more about the DYNAMIC study here .

Complete Omics All Rights Reserved.

Who we are?

Complete Omics, founded in 2019, is a pioneering biotech firm specializing in the clinical application of proteomics. Our founding team, with over a decade of multi-omics expertise from the prestigious Johns Hopkins University School of Medicine, has developed a suite of technologies including clinical proteomic molecular diagnostics. With our innovation-driven research and development center in the U.S. and production & clinical application service center in China, we leverage our extensive patent portfolio to provide a comprehensive clinical diagnostic solution. Our approach, rooted in proteomics-driven multi-omics technology, bridges the gap from scientific research to clinical translation, ushering in a new era of companion diagnostics and personalized treatment.

What products and services does Complete Omics offer?

Complete Omics offers three core platforms and services:

Complete360® Biomarker Screening and Liquid Biopsy Platform —A new technology for in-depth and accurate proteome analysis of body fluids, developed using the gold standard mass spectrometry-based clinical inspection method. It allows for the precise determination of thousands of protein biomarkers, covering a wide range of organs, pathways, and diseases, facilitating the entire process from biomarker discovery to clinical diagnostic application.

Valid-NEO® Neoantigen Discovery and Validation Platform —This platform captures nearly all MHC molecules and antigen peptides on the surface of tumor cells, combined with an optimized mass spectrometry method, to achieve single-cell level absolute quantification of tumor neoantigen peptides, speeding up the development of antibody drugs and vaccines.

CompleteCohort® Clinical Multi-Omics Cohort Study Platformon —Represented by proteogenomics, this platform drives the era of precision medicine with top international team experience in clinical analysis, providing full-process services from design to publication.

Why choose Complete Omics over other Proteomics or multi-omics service companies?

Complete Omics is the developer of the first clinical proteomics-based liquid biopsy (ovarian cancer early diagnosis). There are three features that can distinguish us from any other omics companies:

Expertise and Technological Excellence —Our founders, hailing from the Johns Hopkins University School of Medicine, possess extensive experience in omics and are well-regarded in the field. They have developed leading proteomics technologies and participated in groundbreaking omics projects.

Proprietary Patents and Leadership in Technology —Guided by our founding team, we have developed over 20 significant international patents in proteomics and genomics, all fully owned by the team.

Proven Collaborations and Significant Achievements —We have established extensive collaborations with over 80 renowned research institutions and pharmaceutical companies, contributing to over 20 top-tier publications in areas like tumor neoantigens and large cohort proteogenomics studies.

What is Complete360®?

Complete360® is a cutting-edge liquid biopsy and biomarker screening platform, developed leveraging the gold-standard mass spectrometry-based clinical diagnostic method. It offers unparalleled precision in the analysis of body fluid proteomes, enabling the targeted and stable detection of thousands of protein biomarkers simutanously. This technology comprehensively covers a wide spectrum of organs, pathways, and diseases. It includes precision-targeted quantification of proteins for various specialized panels such as cardiovascular metabolism, oncology, neurology, and immunology, etc., alongside high-throughput versions capable of screening over 5000 potential biomarkers for broad-spectrum initial screening.

Applications of Complete360®:

Complete360® is versatile in its applications, encompassing early-stage disease diagnosis, biomarker validation, and prognostics. It serves as a foundation for developing commercial biomarker assay kits suitable for clinical diagnostics.

Unique Features of Complete360® Compared to Other Technologies:

Complete360® differentiates itself through its superior method of protein target detection. While traditional methods rely on affinity-based detection, such as through antibody- or aptamer-based methods or non-targeted mass spectrometry techniques, Complete360® incorporates advanced strategies like blood low-abundance protein selection combined with targeted mass spectrometry, offering a more comprehensive, precise and reproducible analysis.

Recommended Sample Types and Volumes for Complete360®:

Complete360® primarily recommends plasma samples, but it is also compatible with serum, cerebrospinal fluid, and urine samples among other body fluid samples. For specific recommendations for sample volumes, please contact with customer service.

What is CompleteCohort®?

CompleteCohort® by Complete Omics is a sophisticated technology platform tailored for clinical multi-omics cohort sample studies. It offers end-to-end services from project design, experimental testing, analysis and data generation, to publication support for disease cohort studies. This platform enables clinicians and researchers to delve deeply into the mechanisms of complex diseases, identify subgroups, discover new biomarkers, and explore potential therapeutic methods.

Applications —The platform's applications are extensive, including but not limited to:

1) Proteogenomics studies for identifying molecular subtypes in heterogeneous diseases like tumors, guiding targeted therapy development, and selecting prognostic markers.

2) Developing and designing personalized experiments and analyses for prospective cohorts and multicenter cohorts, using generally available clinical samples like biopsies and FFPE tissues.

3) Solid tissue biomarker screening & liquid biopsy design, and to establish clinical transformation of biomarkers and assay kits for diagnosis, prognosis, disease stratification, and drug response.

Advantages of Clinical Cohort Studies with Complete Cohort —The challenges of large-scale clinical cohort studies are immense, encompassing experimental design, sample testing, data quality, and analysis. Complete Omics' CompleteCohort® platform addresses these with its unique strengths:

1) Expert-led cohort design and publication support, leveraging the experience of co-founders from Johns Hopkins Medicine and CPTAC.

2) Strict multi-dimensional control over sample testing, ensuring data quality and stability with specialized QC samples and protocols.

3) Advanced data analysis capabilities to derive industry insights and support top-tier journal publications.

Service logistics —CompleteCohort® encompasses full-process services from design to publication, integrating technical and business process management to ensure smooth project progression. This approach emphasizes technical liaison through project managers, support from field leaders for project design and publication, and business process coordination by dedicated project managers.

What is Valid-NEO®?

Complete Omics is the developer of the first clinical proteomics-based liquid biopsy (ovarian cancer early diagnosis). There are three features that can distinguish us from any other omics companies:

Valid-NEO®: Pioneering Neoantigen Detection and Quantification Platform

Neoantigen —Unique to tumor cells, are pivotal in cancer immunotherapy, providing a way for the immune system to recognize and attack tumor cells. The study of neoantigens is essential for understanding immune evasion by tumors, advancing personalized medicine, and identifying new immune therapy targets. Neoantigen applications span cancer vaccine development, immune therapies like CAR-T and TCR-T cell therapies, and disease monitoring or personalized treatment strategies.

Advantages of Valid-NEO® —Valid-NEO® is a state-of-the-art platform for the absolute quantification of neoantigens at a single-cell level, addressing key challenges in accurately identifying clinically relevant neoantigens. Unlike traditional sequencing and predictive algorithms, Valid-NEO® directly identifies neoantigens presented on tumor cell surfaces with high specificity and sensitivity, significantly reducing false positives and negatives. The advantages of Valid-NEO® are mainly:

1) Precision and Reduced Trail-and-Error: By directly identifying tumor neoantigens through mass spectrometry, Valid-NEO® eliminates reliance on predictive models, significantly reducing false positives and enhancing mutation detection accuracy.

2) Minimal Sample Requirements: Valid-NEO® achieves neoantigen detection and sequencing from the same sample, requiring as little as 5mg of clinical tissue.

3) Enhanced Sensitivity: Incorporating MaxRec® technology, Valid-NEO® overcomes traditional mass spectrometry limitations, precisely quantifying as few as 0.4 neoantigen copies per cell.

4) Patented Technology: Multiple steps within the Valid-NEO® platform and the platform itself are patented individually, reflecting its recognized innovation in clinical proteomics.

5) Proven Track Record: Valid-NEO® has garnered attention and established long-term collaborations with leading research institutions and pharmaceutical companies, underscoring its leadership in clinical proteomics.