GattaCo, Murrietta, Calif, and iAssay, San Diego, have signed a memorandum of understanding, enabling engineers and scientists to work together to provide enhanced rapid serology testing, including covid-19 antibody testing and electronic test result transmission to federal and state agencies via the cloud at the point of care.
“Helping to alleviate the covid-19 testing bottleneck with improved test accuracy, eliminating the need for centrifugation of blood samples, and reducing clinical lab restrictions will improve patient care and at the same time, provide public health agencies and other vested parties relevant data to support informed decision making and improved management of the covid-19 crisis,” says Michael McNeely, PhD, president and CEO of GattaCo.
GattaCo developed and patented rapid and automatic plasma separation tools, called the A-PON and pediatric-focused mini-PON Kits. The PON Kits (PON referring to plasma at the point of need) separate antibody-rich plasma from whole blood collected from a finger-stick without the need for a centrifuge or venous blood-draw. The plasma generated by the PON Kits can transform a normally Yes or No antibody test into a semi-quantitative test and enable more sensitive quantitative detection by the iAssay CyberReader device, reducing false positives and negatives.
iAssay’s CyberReader automatically quantifies and analyzes covid-19 test strips, then transmits the test results electronically to doctors, hospitals, and state and federal agencies. The Department of Health and Human Services (HHS) now requires that both positive and negative covid-19 test results be reported to them; violators risk being fined $1,000 for the first violation, and $500 per day for ongoing violations.
An Elegant and Complementary Solution
When used as directed, PON derived plasma can be obtained in under three minutes, in any setting, including at a doctor’s office, at home, at screening centers, or anywhere finger-stick blood can be collected. The A-PON and mini-PON Kits require no power, support equipment, or skill on the part of the user, eliminating the need for the phlebotomist, lab tech, and centrifuge infrastructure that is otherwise required to obtain plasma. The battery-powered iAssay CyberReader provides a quick and portable method for analyzing strips incubated with PON produced plasma and stores test results in the cloud.
“It’s a natural fit for both companies,” says Lonnie Adelman, CEO and founder of iAssay. “iAssay provides a sensitive and accurate reader device and cloud connectivity, and GattaCo provides the microfluidics that optimize the strip chemical reactions. Together, we are working on improving the full system performance by using our combined strengths in engineering and biotechnological medical device design.”
US manufacturing and distribution is set to begin as soon as all governmental requirements are met.
Featured image: iAssay CyberReader (Courtesy: iAssay)