Each human disease expresses a unique protein or proteins. These protein(s) expressions become a protein disease biomarker, or a biomarker signature when multiple unique cancer proteins, which are normally found in combination. These protein disease signatures, when combined with proteogenomics analysis are very precise and accurate. If you have the specific cancer disease, you will have the related protein and proteogenomics disease signature(s), without the disease, or if it is cured—the cancer protein and proteogenomics biomarker signatures will not be present.
SmartBio™ is enabling the precision to detect, diagnose, manage therapeutic dosing and monitor the increase/decrease of cancer. The SmartBio's SBi Accurate Cancer Management™ (ACM) is a 2-Part System. Part 1 is the SmartBio™ precise saliva-based cancer detection POC device for specific types of cancer, such as Breast, Prostate, or Lung, etc. The test device provides a GREEN light if there are no active (above healthy baseline) primary cancer proteins detected.
Should you test positive (YELLOW light), your Doctor can order the SmartBio's Accurate Cancer Management™ (ACM) System, which provides confirmation via the SBi-CLIA liquid biopsy proteogenomics blood/urine/saliva clinical laboratory test to further determine the exact type, subtype and stage of cancer. It also identifies optimal Rx therapeutics indexed per exact cancer type (C-type), cancer protein(s) and other proteogenomics biomarker(s) signatures.
The SBi-CLIA proteogenomics test will also be able to track the treatment effect throughout the therapeutic process. When you’re in remission, you can also monitor for reoccurrence, should it occur, with the SmartBio™ Saliva POC detection device.
The SBi—ACM™ 2-Part System, will Detect, Diagnose, Treat and Monitor (DDTM), accurately the entire cancer life cycle, with precision and highly personalized to your exact cancer proteogenomics signatures.
The ACM-System is a 2-part system designed to provide early and accurate detect, diagnosis (Dx), treatment (Tx/Rx), and monitoring (Tx) proteogenomics metrics (DDTM) of specific primary cancers. The SBi detection saliva test device is part 1, and the SBi-CLIA proteogenomics blood/urine/saliva test version-controlled protocol is part-2 of the ACM-System. The SBi-CLIA liquid biopsy provides confirmation using the Proteogenomics Cancer Signatures as the comprehensive cancer metrics-that-matter℠
The SBi smartphone application (SBi-app) will be an important part of the ACM System product development. To obtain the green/yellow light results from the SBi-DTM saliva test, users will be required to pair and synchronize with the SBi-app. Should a yellow light result—indicating the detection of one or more active cancer-related proteins—significant prognostic data will be uploaded and become a part of that patient’s record and be made available to the patient’s clinicians. This baseline prognostic data will also be utilized within the SBi-CLIA proteogenomics blood/urine/saliva test to determine a comprehensive diagnosis of the patient’s complete and precise proteogenomics cancer biomarker signature.
Accompanying the SBi smartphone application will be the SBi CLIA application (SBi-C app) for use by the patient and the clinician. The SBi-C app will be a HIPAA-compliant, highly secure, cloud-based app facilitating easy internet use and access from any connected device. The SBi-C app will be utilized throughout the patient’s cancer treatment lifecycle, tracking and maintaining the patient’s precise, timestamped proteogenomics biomarker signature panels as they evolve.
The SBi-C app will provide the clinician a patient’s exact cancer biomarker signatures along with a number of functions personalized to that patient. For example, the SBi-C app will index the patient’s exact cancer protein biomarkers and cross reference them to the FDA’s Rx-protein database and index with the exact chemotherapeutic Rx agent that therapeutically relates and targets those proteins. Should the patient’s clinician choose to use it, this will enable very precise Rx/Tx care that can continually be monitored during the patient’s cancer treatment lifecycle. The periodic use of the SBi-CLIA test during the Rx/Tx care period will also alert the clinician when these proteins are no longer active, signaling they may want to consider altering/termination of that specific Rx from the patient’s therapeutic regime.
SBi believes this very personalized and precise proteogenomic molecular data, when combined with other clinical laboratory tests and imaging technologies such as mammograms, will greatly aid in the transition of the Art-of-Medicine to the Sciences-of-Health by more successfully managing an individual’s cancer at the molecular level. This is what we mean by Cancer•Metrics•That•Matter℠.
SBi is building a clinical development program with leading Cancer centers to establish and scientifically prove the clinical utility of the SBi—ACM™ 2-Part System. These centers include Johns Hopkins, Cleveland Clinic, MD Anderson, and Albert Einstein Cancer Center.
We are aligned with the US•FDA's initiative related to the Cancer Moonshot, and the 21st Century Cures Act being managed by the FDA's new Oncology Center of Excellence (OCE) department. SBi will work in close collaboration with the FDA’s-OCE to fully establish the scientifically valid evidence to prove the SBi system will manage the metrics-that-matter, of any stage of Cancer accurately.
Sep 18, 2017
Proteogenomics Research: On the Frontier of Precision Medicine Proteomics is the comprehensive study of the complete set or complex of proteins in an organism (called the proteome). Analyzing the proteome of cancer can also provide information on how to best diagnose and treat the patient. When combined with Proteogenomics the comprehensive study of the affiliate genome a more complete picture of cancer is formed. NCI calls this “Proteogenomics”
SmartBio, first product will be SBi—ACM™ 2-Part System for breast cancer. Including the simple and accurate SmartBio™ Saliva POC stick device for breast cancer detection. The SBi saliva-based test device detects the presence or absence of primary active breast cancer proteins, above healthy baselines associated specifically with all types of breast cancer. SBi's IP of cancer biomarkers, including 233 proteins associated with breast cancers and expressed in saliva, is derived from the UTHSC and much of the work is published in scientific journals, such as Nature.
The SBi technology will permit highly accurate salvia-based primary detection testing and if positive, a detailed analytical SBi-CLIA liquid biopsy proteogenomics blood/urine/saliva clinical laboratory test to further determine the exact type and stage of cancer will be ordered by the patient’s clinician.
 Scientific Report: https://www.nature.com/articles/srep30800
This SBi Liquid Biopsy version-controled test will permit further precision Dx of the exact type, subtype & stage of breast cancer, and assist with identification of specific therapeutics effective with specific proteins and proteogenomics, such as Herceptin® with the HER2/neu protein. This proteogenomics/therapeutic alignment is being built into a dosing algorithm project called RAPID in a collaborative development effort at Johns Hopkins University.
As the patient’s cancer transcends into remission, the SBi saliva-based detection device can be utilized periodically by the patient to upload their results to their primary clinician via the SBi App for that. This active monitoring will provide early warning (yellow light) of one or more primary cancer proteins reactivating and afford early anti-cancer-protein precision treatment.
Saliva based biomarkers is not new. Basic research began in early 2000s and is now advancing to applied research and clinical product development. The short video linked below "Salivary Diagnostics" provides an excellent overview.
Check out this great video on Salivary Diagnostics
SBi develops its biomarker products with human protein materials and sciences at the molecular and nano scale. The SBi ACM™ Accurate Cancer Management™ system is a series of specific cancer type lateral flow saliva test strips which must be of the highest quality and integrity, critically important for accurate cancer detection, treatment and monitoring. Our lateral flow assay partner utilizes advanced nano technology that very few companies have mastered—let alone perfected.
SBi has strategically partnered with nanoComposix who is a US•FDA cGMP and ISO13485 compliant manufacturer contract developer of next generation lateral flow in-vitro diagnostics. With innovative, ultra-sensitive nanoparticle probes, covalent binding chemistry and quantitative smartphone-based reader technologies, SBi can accelerate the development and optimization of lateral flow immunoassays for cancer diagnostics. We will use the nanoComposix BioReady™ Nanoparticles for lateral flow.
nanoComposix actually wrote the book on developing lateral flow assays.
nanoComposix is a 12-year-old company that has provided monodisperse and unagglomerated metal and metal-oxide nanomaterials to thousands of customers. Hundreds of different variants of material, size, shape, and surface are available as stock products and they have produced over 2000 custom core/shell, biofunctionalized, fluorescent, and magnetic nanocomposites to meet client specifications. nanoComposix produced the NIST nanosilver reference material and their particles have been utilized in over 400 peer-reviewed publications. All of their materials are supplied with certificates of analysis that include electron microscopy, hydrodynamic diameter, and optical data for each batch to guarantee products meet specifications. Contract manufacturing is performed on scales that range from small beakers to thousands of liters. Nanomaterials for medical devices and clinical trials are produced in their ISO13485 and US•FDA cGMP compliant cleanroom facility. By leveraging their unique library of nanomaterials, they help their customers rapidly bring nano-enabled products from concept to commercialization.
SmartBio is developing ACCURATE CANCER MANAGEMENT™ SYSTEM (ACM-System). The ACM-System is a 2-part system designed to provide accurate detection, diagnostic, Rx treatment metrics and monitoring of specific primary cancers. The SBi saliva detection test device is part 1, and the SBi-CLIA proteogenomics blood/urine/saliva test protocol is part-2 of the ACM-System.
SBi-CLIA comprehensive proteogenomics blood, urine & saliva test
SBi's Proteogenomics, or the integration of proteomics with genomics and transcriptomics, is an emerging approach that promises to advance basic medical arts, to translational and clinical sciences. By combining genomic and proteomic information, SmartBio is gaining new insights due to a more complete and unified understanding of the molecular complex cancer biological processes.
Some news we can use:
On October 23rd, two articles published in Nature and Nature Genetics revealed that an international team of 550 researchers in six continents, had identified 72 new genes associated with breast cancer, potentially heralding a new age of more targeted breast cancer screening and treatment.
Genes and Breast Cancer: Researchers Discover 72 New Mutations That Increase Risk
A continuous journey of improvement — not an event…
Dr. Janet Woodcock, Director of the FDA’s Center for Drug Evaluation and Research (CDER), describes what biomarkers are and why they’re important to the drug development process on this video
Learn more about FDA’s Biomarker Qualification Program
The US-FDA has additional video information on Biomarkers here.
Effective, unambiguous communication is essential for efficient translation of promising scientific discoveries into approved medical products. Unclear definitions and inconsistent use of key terms can hinder the evaluation and interpretation of scientific evidence and may pose significant obstacles to medical product development programs. Lack of clarity and consistency is also problematic in other scientific areas where FDA oversees product safety (e.g., foods and tobacco) to promote public health interests.In the spring of 2015 the FDA-NIH Joint Leadership Council identified the harmonization of terms used in translational science and medical product development as a priority need, with a focus on terms related to study endpoints and biomarkers. Working together with the goals of improving communication, aligning expectations, and improving scientific understanding, the two agencies developed the BEST (Biomarkers, EndpointS, and other Tools) Resource.
Access US-FDA's BEST publication here.
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