diagnostic testing

  • sam patrick posted an article
    DPX Technologies introduces new product line see more

    DPX Technologies, a manufacturer of laboratory consumables for sample preparation, announces the development of a new product line for size exclusion chromatography. The technology is patent-pending and utilizes a novel INTip swelling method that supports a hands-off approach for size exclusion chromatography workflows. The automated INTip swelling process allows the gel resin bed to be prepped and ready for sample application in less than 20 minutes.

    Size exclusion chromatography (SEC), also known as gel filtration, is a method by which molecules pass through SEC resin media and are separated by their size. The DPX methodology uses a group separation technique for desalting and buffer exchange where small molecules such as salts are separated from a group of larger molecules such as proteins. Desalting and buffer exchange are commonly used prior to affinity chromatography for antibody purification or polymerase chain reaction (PCR) cleanup. The new product line includes SEC pipette tips and automation accessories, offering a highly reproducible, automated solution for proteomics applications.

    Antibody testing and PCR cleanup are highly conversed topics due to the COVID- 19 pandemic, and DPX is committed to developing products that simplify and automate complex sample preparation for biological matrices. “This new product, along with INTip filtration products for Tip-on-Tip solid phase extraction, will help laboratories that need high throughput methods for processing thousands of samples daily, ” said Dr. Matthew Fitts, lead molecular biologist at DPX Technologies.

    DPX has been manufacturing pipette tips for sample preparation since 2007 and specializes in developing custom workflows for a diverse client base.

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    About DPX Technologies

    DPX is committed to providing innovative sample purification solutions. We collaborate with our customers to provide the high-quality products they need for complex chemical and biological analysis.

  • sam patrick posted an article
    Key evidence to be presented at AACR 2020 see more

    KIYATEC, Inc. today announced that it will present data at the 2020 American Association for Cancer Research (AACR) Annual Meeting, June 22-24, revealing how its 3D cell culture models characterize ex vivo tumor response and immunoreactivity to immune checkpoint inhibitors (i.e. PD-1, PD-L1 inhibitors) in solid tumors. These emerging capabilities address a significant unmet need in both preclinical drug development and clinical decision-making in oncology.

    PD-1/L1 inhibitors have experienced meteoric growth over the last decade, offering hope to hundreds of thousands of cancer patients every year in the US alone. However, typically no more than 25-30% of eligible cancer patients who receive PD-1/L1 inhibitors actually respond to them. Given that the direct costs associated with PD-1/L1 therapy can run into the hundreds of thousands of dollars per patient, KIYATEC believes that pre-treatment, patient-specific PD-1/L1 response prediction could one day offer clinicians, patients and payers a more objective basis for determining PD-1/L1 inhibitor patient eligibility vs. today’s commonly used population-based biomarkers. 

    Evidence presented by KIYATEC at AACR 2020 will highlight findings of the company’s ability to detect dose-dependent response to checkpoint blockade and corresponding correlation with immune cell activation in high-throughput ex vivo 3D tumor spheroid models. KIYATEC believes these recent advances may represent key building blocks toward the eventual development and validation of clinical assays capable of accurate pre-treatment, patient-specific prediction of response to immuno-oncology drugs. 

    “We’re constantly innovating and expanding the capabilities of our 3D cell culture technologies to reduce the cost and risk of preclinical drug development for our immuno-oncology customers,” said Matthew Gevaert, CEO of KIYATEC. “As we continue to make these advances in immuno-oncology drug response on higher-throughput platforms, we can begin to envision a time when such capability would inform clinical decision-making for cancer patients as well.”

    KIYATEC’s poster presentations at AACR 2020 are as follows:

    Title: Multifaceted functional assessment of checkpoint inhibitor efficacy using 3D tumor spheroids

    • Abstract: 7397 / Poster: 315 / Session: 3D & Tissue Recombinant Models / June 22-24

     

    Title: PARP inhibition in combination with pembrolizumab enhances cytotoxicity in ovarian cancer patient-derived 3D spheroids

     

    Title: The perfused 3DKUBETM rare tumor assay models in vivo drug response

    • Abstract: 7132 / Poster: 2244 / Session: Immune Checkpoints 2 / June 22-24

     

    About KIYATEC, Inc.

    KIYATEC leverages its proprietary ex vivo 3D cell culture technology platforms to accurately model and predict response to approved and investigational cancer drugs targeting a spectrum of solid tumors. The company’s Drug Development Services business works in partnership with leading biopharmaceutical companies to unlock response dynamics for their investigational drug candidates across the majority of solid tumor types. The company’s Clinical Services business is currently engaged in the validation of clinical assays as well as investigator-initiated studies in ovarian cancer, breast cancer, glioblastoma and rare tumors, in its CLIA-certified laboratory. To learn more about KIYATEC, visit www.kiyatec.com.

  • sam patrick posted an article
    Nephron announces new partnership see more

    Nephron Pharmaceuticals Corporation, one of the fastest growing pharmaceutical companies in the country, announced a new partnership with One Medical, a leading national digital health and primary care organization that combines 24/7 access to virtual care and digital health tools with COVID-19 testing services to businesses and employees.

    “Re-opening businesses, and getting our economy moving again, is one of our highest priorities,” said Nephron CEO Lou Kennedy, who is a member of Governor Henry McMaster’s #accelerateSC, the coordinated COVID-19 advisory team tasked with recommending economic revitalization plans for South Carolina. “Part of the new normal for businesses is testing employees to make sure the workplace is safe. We couldn’t be prouder to offer COVID-19 testing services to our employees and neighbors.”

    Kennedy and John Singerling, Chief Network Officer of One Medical and a longstanding healthcare executive based in South Carolina, are working together to make this partnership a reality, hoping that it serves as an example for businesses around the country.

    The Nephron CLIA-Certified lab has procured state-of-the-art technology for COVID-19 real-time PCR testing and serological antibody testing for its own employees, and for employees of neighboring businesses. The lab intends to integrate with One Medical’s technology platform, which is capable of supporting a comprehensive workplace reentry COVID-19 testing program. One Medical’s virtual care solutions facilitate scheduling for specimen collection and digitally documenting those test results. It also screens and evaluates clinical risk factors and symptoms and supports employer tracking and reporting needs.

    “I am very pleased to be working alongside the Nephron team to leverage One Medical’s digital health platform as a way to help get South Carolinians back to work safely,” said One Medical Chief Network Officer, John Singerling. “Currently working with over 7,000 employers nationwide has allowed One Medical to build a comprehensive workplace reentry program that is grounded in medicine and testing, and powered by our technology, which allows for seamless tracking, tracing and ongoing monitoring.”

    SARS-CoV-2 PCR tests diagnose whether a person is infected with the virus by using technology that analyzes viral genetic material. Antibody tests check blood for antibodies. If present, antibodies indicate a person has been previously or is currently infected by the virus.

     

    Nephron Pharmaceuticals Corporation has been on the frontlines of the nationwide COVID-19 response. The West Columbia-based company develops and produces safe, affordable generic inhalation solutions and suspension products that can be used to treat severe respiratory distress symptoms associated with COVID-19. In addition, the company operates an industry-leading 503B Outsourcing Facility division which produces pre-filled sterile syringes and IV bags for hospitals across America, in an effort to alleviate their drug shortage needs. These products are used, many times, to sedate patients and keep them comfortable when health care professionals place them on ventilators in the fight against the virus.

  • sam patrick posted an article
    Veravas partners to develop test see more

    True Diagnostics, Inc. (TrueDx), a leading Point of Care (POC) company, Infectolab Americas (Infectolab), a recently established CLIA laboratory specializing in comprehensive testing for tick-born infection, and Veravas, Inc. (Veravas), an emerging diagnostic company focusing on proprietary sample preparation products and new diagnostic tests, announced today their Strategic Alliance to develop and commercialize VeraTest™ SARS-CoV-2 IgA/IgG Rapid Test. This novel POC test will utilize the TrueDX Platform™, Infectolab's COVID-19 serology testing services and infectious disease expertise,and Veravas' patent pending VeraPrep™ clean and VeraPrep™ capture technologies to remove cross-reacting antibodies to other coronaviruses while only binding and detecting antibodies specific to SARS-CoV-2. Serology testing makes population screening possible, including screening of people who were never diagnosed, either because they didn't feel particularly sick or they couldn't get an initial test. VeraTest™ SARS-CoV-2 IgA/IgG Rapid Test will play an important roll in understanding COVID-19 and the epidemiology of this coronavirus.

    VeraTest™ SARS-CoV-2 IgA/IgG Rapid Test will provide a digital qualitative answer in less than 15 minutes to determine if antibodies against COVID-19 have been detected in the blood. IgM and IgA provide the first line of defense during viral infections, followed by the generation of adaptive, high-affinity IgG responses for long-term immunity and immunological memory. The detection of COVID-19 IgA antibodies tends to indicate a recent exposure to COVID-19 and is more specific for COVID-19 in lung tissues and mucosal surfaces, and detection of COVID-19 IgG antibodies indicates a later stage of infection, so this combined antibody test could also provide information on the stage of the disease in patients. Current guidance from the U.S. Food and Drug Administration (FDA) recommends that results from antibody testing should not be used as the sole basis to diagnose or exclude coronavirus infection. Depending on the clinical scenario, additional testing, such as with VeraTest™ COVID-19 IgA/IgG Rapid Test, may be considered to further evaluate the possibility of SARS-CoV-2 infection.

    "In these challenging times, True Diagnostics, Inc. is proud to be part of this alliance to help expedite critical solutions that can help provide the needed specificity, performance, scalability, and simplicity to market," stated Jerry Lee, CEO and President of True Diagnostics. "Veravas is quickly emerging as the leader in raising the standard of care in laboratory medicine and we look forward to co-developing tools that are essential to support the IVD market and improving the lives of so many patients."

    "A collaboration between Infectolab Americas and Veravas is the logical consequence for our two Minnesota companies. We are complementary to each other and have a lot of synergy. We will use this to achieve something that is desperately needed in this time of testing crisis. We will strive to deliver a high quality test for SARS-CoV-2 that is more accurate and sensitive than any other test on the market," said Felix Scholz, President of Infectolab Americas.

    "This strategic alliance with TrueDx utilizing their TrueDX Platform™, along with Infectolab's CLIA lab validation capabilities and infectious disease expertise, will allow Veravas to quickly develop a POC test that's easy to use and displays results in under 15 minutes. We are confident that the combined efforts of our three companies will result in the successful development of a rapid test that will assist healthcare providers and laboratorians to quickly and reliably determine whether a patient has developed antibodies to the COVID-19 virus. Most importantly, it will identify those individuals who can safely return to work and go about their daily lives," said Carroll E. Streetman Jr., Chief Executive Officer of Veravas.

    TrueDx and Veravas continue to collaborate and expand their portfolios with other emerging organizations and institutions to bring diagnostic solutions and products like VeraTest™ to market.

    About True Diagnostics
    True Diagnostics (TrueDx) designs and develops innovative POC diagnostic tests and devices based on its proprietary TrueDX™ Platform, which utilizes reliable and low-cost lab methods and its own proprietary or partnered biomarkers to offer rapid diagnoses to facilitate treatment decisions in point-of-care, point-of-incidence and remote-of-care settings. The TrueDX Platform's portability and affordability allow it to be easily adopted into emerging markets to provide accurate diagnosis within minutes. For the $21 billion point-of-care market, the power of the TrueDX Platform lies in its simplicity and flexibility. Tests have an 18-month or longer shelf life with no refrigeration required. The platform's flexible design additionally permits it to quickly commercialize a myriad of biomarkers discovered for cancer, autism, Alzheimer's, diabetes, drugs of abuse, infectious diseases, cardiac health, traumatic brain injury, viral and bacterial infections and more.

    About Infectolab Americas
    Infectolab Americas is a recently established laboratory located in Oakdale, Minnesota, specializing in comprehensive lab testing for tick-borne infections which provides the tools necessary for Health Care Practitioners to diagnose tick-borne diseases. Their focus is on delivering a quality laboratory performance and guaranteeing a superior sample output; this entails quick shipping time and a rapid turnaround time, as well as providing the most accurate laboratory results possible.

    About Veravas
    Veravas is transforming laboratory medicine with technology that delivers superior test results, providing confidence to clinicians and patients that diagnoses are accurate. The company's R&D facilities are based in Oakdale, Minnesota, and our staff of scientists and business development are rapidly driving the commercialization of proprietary sample preparation products and new diagnostic tests. Veravas' nanomagnetic particles can identify, remove, and measure select substances from patient samples to reduce the effects of complex interferences and detect low-abundance biomarkers. Led by a passionate and dedicated team, Veravas is devoted to improving patient lives by minimizing the harmful effects of unnecessary treatments and deaths associated with poor quality diagnostic results. Because every patient deserves the correct result, every time. Please visit us at www.veravas.com