Affinimark Receives Breakthrough Designation from FDA for Diagnostic in the Detection of Cerebral Spinal Fluid Leaks in Patients

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FDA will expedite review and development of new, real-time CSF test

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Affinimark Technologies, Inc. ( Affinimark), a development-stage diagnostics company dedicated to improving timely diagnosis and treatment for patients, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Designation for its review of Affinimark’s proprietary Cerebral Spinal Fluid (CSF) Test Strip, a revolutionary diagnostic strip intended for real-time detection of cerebral spinal fluid leaks. FDA Breakthrough Designation expedites the Agency’s review of medical devices that can provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.

Affinimark’s CSF test works much like a pregnancy test, yielding a positive or negative result when suspected fluid is tested. The immediate feedback assists the clinician making a diagnosis and helps to determine if any intervention is necessary to address a CSF leak. CSF supports and bathes the brain and central nervous system. Leaks occur when a tear or hole forms in the dura, the membrane that surrounds the brain and spinal cord, allowing fluid to seep out, increasing the risk of infection.

“The FDA’s granting of Breakthrough Designation for our CSF Test Strip underscores the urgent need for a diagnostic tool that provides on-the-spot, immediate results upon suspicion of a CSF leak in patients,” said Ellie Tandler, President and Chief Executive Officer at Affinimark. “CSF leaks increase the risk of meningitis and other neurological complications, so timely diagnosis and urgent and effective repair of the defect are essential. We appreciate the review and decision by the FDA and plan to work closely with the Agency to commercialize our CSF Test Strip by early 2021.”

Among the benefits of FDA Breakthrough Designation are a commitment from the FDA for more rapid review timelines, ongoing discussion and submission review, and access to FDA senior management to develop a plan that is as least burdensome as possible and allows for some measure of flexibility and adjustment. The FDA’s decision was based on recognition of Affinimark’s CFS Test Strip as a timely diagnostic tool that can aid in the diagnosis of CSF leakages more quickly than other available in vitro diagnostic (IVD) devices with the same or similar intended use.

“Our device has completed proof-of-concept and prototyping. We are raising a Series C round of financing to fund the clinical trial and analytical bench testing of the strip over the next 18 months for a de novo 510(k) submission to the FDA by Q1 2021,” added Tandler.

Current technologies for detecting CSF fluid leaks, such as imaging and scans, are time-consuming, expensive and inconvenient for the patient. A beta-2 transferrin lab test can detect CSF; however, the test requires a relatively large volume sample (as compared with Affinimark’s test), can be cumbersome to run and can produce inaccurate results when blood is present in the sample. Its performance data have not been reviewed by the FDA.

About Affinimark Technologies, Inc.:
Affinimark Technologies, Inc., is a privately held diagnostics company located in Guilford, CT. Its primary investors include CT Innovations and Launch Capital, as well as individual founders.

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Wendy Anderson
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