Six groups advance to Part 3 of LymeX Diagnostics Prize

Six groups advance to Part 3 of LymeX Diagnostics Prize

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The Steven & Alexandra Cohen Basis, led by philanthropist Alex Cohen, has launched Part 3 of the LymeX Diagnostics Prize by means of a fiscal sponsorship with the Digital Harbor Basis.

This part invitations six groups from Part 2 to plan scientific efficiency research for validating their proposed options.

Over the following 4 months, the Part 3 groups can have entry to webinar modules, mentorship, and networking alternatives. The purpose of the multiphase competitors is to nurture the event of diagnostics towards Meals and Drug Administration (FDA) overview.

With an estimated 476,000 circumstances in America yearly, the U.S. has an pressing want for brand new Lyme disease diagnostics. The present two-tier antibody testing system—initially developed in 1994 for illness surveillance, not as a stand-alone diagnostic check—depends on the presence of antibodies and might solely be used precisely 4 to 6 weeks after a affected person turns into contaminated. Delayed diagnoses forestall well timed and essential remedy interventions.

Meet the groups

Listed below are the groups taking part in Part 3:

  • BlueArc Biosciences Inc. (La Jolla, California). A molecular diagnostic blood check for B. burgdorferi s.l. utilizing an progressive polymerase chain response (PCR) assay and normal laboratory gear to focus on biomarkers.
  • Drexel University College of Medicine (Philadelphia). A small-volume serum check utilizing glycan biomarkers to detect lively Lyme disease an infection and observe remedy response.
  • HelixBind Inc. (Boxborough, Massachusetts). An ultrasensitive, automated check detecting and figuring out lively B. burgdorferi immediately from blood in three hours.
  • Massachusetts General Hospital (Boston). A plasma check depleting human background materials from samples and detecting low-abundance nucleic acid from tick-borne pathogens.
  • Northwestern University, Feinberg School of Medicine (led by Jutras Lab, previously at Virginia Tech.) (Chicago). A check utilizing monoclonal antibodies along side each immuno-PCR and lateral circulate to quickly detect a singular B. burgdorferi biomarker in blood and urine.
  • Tufts University (Boston). A serum check concentrating on a singular antibody that might precisely determine early an infection and permit clinicians to optimize extra remedy.

From April by means of August, the cohort can have entry to technical help on subjects akin to regulatory planning, scientific examine design and implementation, clinician and affected person issues, manufacturing processes and high quality administration methods, and business improvement.

To assist analysis and encourage progressive approaches, the LymeX Diagnostics Prize will publish a goal product profile for a diagnostic check throughout Part 3.

Cohort to current diagnostic assessments at Demo Day

In Fall 2024, the Part 3 groups will current and publicize their diagnostic check at Demo Day, showcasing their proposed options to representatives from authorities and trade, together with clinician and shopper organizations.

Following Demo Day, every staff will submit an idea paper that particulars the FDA engagement undertaken and implementation of suggestions acquired, new or improved analytical efficiency information, remaining scientific efficiency examine protocol, and progress achieved in planning and initiating its scientific efficiency examine.

Part 3 to award as much as $2.1 million in prizes

The competitors judging panel—composed of specialists throughout sectors akin to biology, scientific and expertise translation, affected person expertise and advocacy, diagnostic science and expertise, innovation, and ethics—will consider eligible submissions based on official Part 3 analysis standards. Based mostly on this analysis and judges’ suggestions, Part 3 will award as much as six prizes of $350,000 every.

Part 4 to advance diagnostics towards FDA overview 

The LymeX Diagnostics Prize helps groups overcome diagnostic improvement boundaries by offering funding and technical help whereas fostering cross-disciplinary collaboration and partnerships. Part 4 will assist groups as they execute scientific validation plans and full regulatory submissions to the FDA, awarding as much as $3 million in prizes. The competitors anticipates awarding extra prizes for FDA clearance.

SOURCE: LymeX Diagnostics Prize



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