NEW YORK (GenomeWeb) – Group K Diagnostics said today that it has inked an agreement with the US Centers for Disease Control and Prevention to design and evaluate a prototype reverse transcriptase loop-mediated isothermal amplification (RT-LAMP) assay for the detection of Zika virus (ZIKV) RNA at the point of care.
The device is being developed for use by healthcare practitioners in resource-limited areas where real-time RT-PCR instrumentation is not available, Group K said.
The goal of the collaboration is to transform a test tube-based RT-LAMP assay for the detection of ZIKV developed by the CDC into a non-invasive, rapid detection technology.
Financial and other terms of the agreement were not disclosed.
Most suspected ZIKV positive specimens are sent to a state public health laboratory or the CDC. Group K said a point-of-care assay would expedite the testing and diagnosis process in suburban and remote geographic regions, and enable care providers to implement infection control procedures at the primary visit.
The firm said that with access to such rapid testing, the assay could be used throughout pregnancy, which is necessary for prenatal care of women living in areas at risk of ZIKV transmission.
Under the agreement with the CDC, the firm is contributing expertise in microfluidic point-of-care testing and an understanding of logistical demands in resource-limited areas.
Brianna Wronko, founder and CEO of Group K, said in a statement that the firm anticipates the collaboration with the CDC will yield technology that will change the existing processes for ZIKV testing as well as the frequency of testing.
"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," she said.
The firm noted that it completed liver function inpatient clinical trials at Penn Medicine in December and submitted the findings to the US Food and Drug Administration to obtain marketing clearance. Each liver function test had an accuracy rate of 98 percent or higher for whole blood testing, Group K said.
The company is in pre-clinical trials for a comprehensive metabolic panel, and it recently expanded its manufacturing, lab, and office spaces to keep up with ongoing growth and development.