PHILADELPHIA, March 26, 2019 /PRNewswire/ -- Group K Diagnostics (GKD), a biotechnology innovator aiming to overhaul the diagnostic process for both patient and caregiver, has signed an agreement with the Centers for Disease Control and Prevention (CDC) to design and evaluate a prototype reverse transcriptase loop-mediated isothermal amplification (RT-LAMP) assay for the detection of the Zika virus (ZIKV) RNA that can be performed by clinical personnel or health care practitioners in resource-limited areas where real-time RT-PCR instrumentation is not available.
Currently, the majority of suspected ZIKV positive specimens are sent to a state public health laboratory or the CDC. A point-of-care solution would vastly expedite the testing and diagnosis process for those in both suburban and remote geographic regions, and allow care providers to update patient care plans and implement infection control procedures at the primary visit. ZIKV has emerged as a major global public health concern in the last three years.
"With my background in point of care diagnostics, I've seen first-hand the impact point-of-care testing can have on regions with limited resources, and the potential is truly remarkable," said Dr. Reshma Rajan, diagnostic engineer, GKD. "Our team is honored to partner on this monumental advancement of point-of-care diagnostics, and we look forward to working with the CDC to bring a new, life-saving technology to market."
The goal of this collaboration is to transform the test tube-based RT-LAMP assay for the detection of ZIKV developed by the CDC (PCT Application No. PCT/US2018/029738) into a non-invasive, rapid detection technology that can be performed in a clinical setting. This access to rapid testing will also be an important tool that can be used throughout pregnancy – a necessity for prenatal care of women living in areas at risk of ZIKV transmission. The team at GKD is contributing expertise in microfluidic point-of-care testing and a deep understanding of the logistical demands in resource-limited areas.
"As our diagnostic solution, the MultiNostic Test Kit, continues to advance through clinical trials and FDA submissions, we're more confident than ever that this collaboration will yield a technology that will change the existing testing processes for and frequency of ZIKV testing in both major metropolitan areas and resource-limited regions of the world," said Brianna Wronko, founder and CEO, GKD. "The raw materials and scalable manufacturing process we employ enable a very low cost product, making our solution an ideal choice for the CDC research collaboration, and ultimately a catalyst for the evolution of infectious disease diagnostic testing at-large."
GKD has made significant progress in the last few months to advance its paper microfluidic diagnostic solution. Most recently, GKD completed its liver function inpatient clinical trials at Penn Medicine on December 21, 2018, and submitted the findings to the FDA. Each liver function test had an accuracy rate of 98% or higher for whole blood testing. The company is now in pre-clinical trials for its comprehensive metabolic panel, and has recently expanded its manufacturing, lab and office spaces to keep up with ongoing growth and development.
About Group K DiagnosticsGroup K Diagnostics (GKD) is a biotechnology innovator aiming to overhaul the diagnostic process for both patient and caregiver. The company's microfluidic point-of-care device, the MultiNostic, is capable of delivering results in just 20 minutes for more than 60 blood tests, streamlining the logistical process historically associated with lab work, maximizing patient-care transparency and allowing physicians to adjust medical treatments in a timely manner. The MultiNostic is pending FDA approval for liver function testing, and in pre-clinical trials for its complete metabolic panel test.
GKD is headquartered in Philadelphia and has a full development team based in India. For more information, visit GroupKDiagnostics.com.
Media Contact: Kim Cox[email protected] 215-867-8600 ext. 220
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Currently, the majority of suspected ZIKV positive specimens are sent to a state public health laboratory or the CDC. A point-of-care solution would vastly expedite the testing and diagnosis process for those in both suburban and remote geographic regions, and allow care providers to update patient care plans and implement infection control procedures at the primary visit. ZIKV has emerged as a major global public health concern in the last three years.
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"With my background in point of care diagnostics, I've seen first-hand the impact point-of-care testing can have on regions with limited resources, and the potential is truly remarkable," said Dr. Reshma Rajan, diagnostic engineer, GKD. "Our team is honored to partner on this monumental advancement of point-of-care diagnostics, and we look forward to working with the CDC to bring a new, life-saving technology to market."
The goal of this collaboration is to transform the test tube-based RT-LAMP assay for the detection of ZIKV developed by the CDC (PCT Application No. PCT/US2018/029738) into a non-invasive, rapid detection technology that can be performed in a clinical setting. This access to rapid testing will also be an important tool that can be used throughout pregnancy – a necessity for prenatal care of women living in areas at risk of ZIKV transmission. The team at GKD is contributing expertise in microfluidic point-of-care testing and a deep understanding of the logistical demands in resource-limited areas.
"As our diagnostic solution, the MultiNostic Test Kit, continues to advance through clinical trials and FDA submissions, we're more confident than ever that this collaboration will yield a technology that will change the existing testing processes for and frequency of ZIKV testing in both major metropolitan areas and resource-limited regions of the world," said Brianna Wronko, founder and CEO, GKD. "The raw materials and scalable manufacturing process we employ enable a very low cost product, making our solution an ideal choice for the CDC research collaboration, and ultimately a catalyst for the evolution of infectious disease diagnostic testing at-large."
GKD has made significant progress in the last few months to advance its paper microfluidic diagnostic solution. Most recently, GKD completed its liver function inpatient clinical trials at Penn Medicine on December 21, 2018, and submitted the findings to the FDA. Each liver function test had an accuracy rate of 98% or higher for whole blood testing. The company is now in pre-clinical trials for its comprehensive metabolic panel, and has recently expanded its manufacturing, lab and office spaces to keep up with ongoing growth and development.
About Group K DiagnosticsGroup K Diagnostics (GKD) is a biotechnology innovator aiming to overhaul the diagnostic process for both patient and caregiver. The company's microfluidic point-of-care device, the MultiNostic, is capable of delivering results in just 20 minutes for more than 60 blood tests, streamlining the logistical process historically associated with lab work, maximizing patient-care transparency and allowing physicians to adjust medical treatments in a timely manner. The MultiNostic is pending FDA approval for liver function testing, and in pre-clinical trials for its complete metabolic panel test.
GKD is headquartered in Philadelphia and has a full development team based in India. For more information, visit GroupKDiagnostics.com.
Media Contact: Kim Cox[email protected] 215-867-8600 ext. 220
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