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MISAA, LLC commenced FDA process for patent pending, tacrolimus enhanced lateral flow assay

TORRANCE, Calif., Feb. 13, 2024 /PRNewswire/ -- MISAA and IOS are pleased to announce they have commenced the FDA certification process for the patent pending, tacrolimus immunosuppressant in vitro diagnostic, Tac-Assay.  MISAA, LLC. (, a subsidiary of Intelligent Optical Systems, Inc. ("IOS"), commercializes medical devices.  The tacrolimus enhanced Lateral Flow Assay is a proprietary, simple, quantitative & low-cost test with the potential to be administered much like a blood glucose test.  The MISSA Tac-Assay has essentially the same sensitivity as the reference gold standard LC-MS method over the therapeutic range but takes only 15 minutes instead of 12 hours. 

MISAA and IOS have commenced the FDA certification process for a patent pending, tacrolimus in vitro diagnostic eLFA.

According to MISAA CEO Reuben Sandler, "When available in the market, the patent-pending Tac-Assay will enable monitoring of tacrolimus levels at nearby clinical labs, doctors' offices and eventually in the home, eliminating the need for lengthy patient visits to a hospital or clinical lab. This could significantly improve the quality of life for transplant patients and make patient management easier and likely reduce the cost of patient care." 

This exciting new product allows the determination of tacrolimus levels in whole blood using a highly portable, fast responding eLFA cassette and only a fingerstick of patient blood.  The product was subjected to a randomized human subject study performed in collaboration with UC Irvine for 54 kidney transplant patients, comparing the levels of the immunosuppressant drug tacrolimus in a single 10 uL drop of fingerstick blood.  The results were compared with those levels measured using the gold standard LC-MS method that requires several mL of venous blood.  The agreement of the two methods in this study showed that the MISSA assay can be used to manage tacrolimus dosing.

Regular monitoring of immunosuppressant drugs like tacrolimus is necessary for transplant patients:  too low a level of tacrolimus leads to organ rejection, whereas too high a level leads to kidney damage. 

There is an offering for MISAA, LLC on the Netcapital website, at

For further information, contact MISAA CEO Reuben Sandler at

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SOURCE Intelligent Optical Systems Inc.

By: PR Newswire Association LLC. - 13 Feb 2024
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