Short Story
This is an RT-PCR multiplex assay for 4 pathogen targets (Escherichia coli, Klebsiella pneumoniae, Staphylococcus aureus, and Enterococcus faecalis) associated with UTI, plus 1 extraction / amplification control requiring 1 reaction tube, utilizing FAM, HEX, Texas Red, Cy5, and TAMRA. This multiplex is based on the UTI reagents listed on the LISA products website and is designed for extraction from urine samples. The goal of this project is to develop the assay to achieve U.S. regulatory clearance. Backers should consider funding UTI project panels 1-3 to get a comprehensive target set.
UTI Multiplex Panel #1
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$850,000
Funding Goal -
$20,000
Funds Raised -
280
Days to go -
Goal and Date
Campaign End Method
| Benefit & Details | Supporter | Bronze | Silver | Silver early | Gold | Gold early | Platinum | Diamond |
|---|---|---|---|---|---|---|---|---|
| UTI Reactions/ year | N/A | 800 | 1350 | 1350 | 2100 | 2100 | 4000 | 10150 |
| RUO Product Discount | 0% | 5% | 7.50% | 7.50% | 10% | 10% | 15% | |
| cGMP Product Discount | 0% | 5% | 7.50% | 7.50% | 10% | 10% | 15% | |
| 510k Product Discount | 0% | 5% | 7.50% | 7.50% | 10% | 10% | 15% | |
| Invoice Frequency / year | 1X | 1X | 2X | 2X | 2X | 2X | 4X | 4X |
| Opt-in to be listed on Submission | V | V | V | V | V | V | V | |
| Access to V&V Report Updates | V | V | V | V | V | V | V | |
| Carry over credits for purchased product | V | V | V | V | V | V | ||
| Lab name recognized on IFU | V | V | V | V | ||||
| Lab name recognized on Box | V | V | ||||||
| Invitation to Gate reviews | V | V | ||||||
| Reserve Option (w/2 years) | V | |||||||
| Project Initiation | $5,000 | $5,000 | $5,000 | $5,000 | $5,000 | $5,000 | $5,000 | $5,000 |
| Amount Pledge / year | $5,000 | $6,000 | $10,000 | $10,000 | $15,000 | $15,000 | $30,000 | $75,000 |
| Years backing committment | 2 | 3 | 2 | 2 | 2 | 2 | 2 | 2 |
| Seat Limits | 2 | 2 |
Campaign Story
Urinary tract infections (UTIs) are common bacterial infections that result in billions of dollars in annual health care costs and affect an estimated 150 million people globally. In 2018 the U.S. had an estimated 10.5 million UTI-related hospital visits and over 3 million US hospitalizations of complicated UTIs alone. UTIs pose a major public health problem. Although traditional urine culture is regarded as the gold standard for detection and identification of pathogens, RT-PCR tests are growing as a potentially superior method due to outperforming traditional urine culture in many performance specifications, costs, ease-of-use, timeliness, and more.
This assay development project is for an accurate, reliable, high throughput, scalable and cost-effective approach to answer the demand for increased testing capability with an assay that can achieve U.S. regulatory clearance.
We estimate this project will take 1.5-2.2 years of development work. In the development process, we might opt to move to a lyophilized format. This will make the product stable at room temperature, require no refrigeration, and be environmentally friendly as it substantially reduces emissions created during transport and storage. We will take into account advice from teams that pledge on whether they want a lyophilized solution.
- This panel is intended to be used in conjunction with other LISA UTI Panels but can be used standalone.
- The multiplex pathogen targets are: Escherichia coli, Klebsiella pneumoniae, Staphylococcus aureus, Enterococcus faecalis.
- Each multiplex reaction tube has an extraction/amplification control included. Mastermix included.
- Dyes: We anticipate using FAM, HEX, Texas Red, Cy5, and TAMRA.
- Extraction: Bead format
- Targeted reaction volume: 15ul
- Instrument: We anticipate QS5 Dx or QS7 Dx, Kingfisher Flex
Pledge Levels and Information:
Pledges: Pledges are 2 years (or 3 years for Bronze), the amount listed is pledged per year and includes a project initiation contribution. Pledging is made by purchasing UTI reagents (for Bronze-Platinum levels). Reagents do not need to be purchased until the project reaches funding threshold but any reagent purchased prior to the funding threshold will be counted towards the minimum. At Silver, Gold, Platinum and Diamond levels, annual unused reagent minimum may be carried forward (one year maximum) for credit the following year.
Once pledge threshold is reached, the project will be funded and initiation contribution pledges invoiced. The project will be placed on the development path for regulatory submission. New pledges will be accepted until the end date. After the end date, no new pledges will be accepted. If the project does not reach threshold, no pledge contributions are invoiced and there is no obligation to pledge members.
Level Summary
- Supporter: Designed for labs that want to reserve their options for the future, this level does not require purchase of reagents. Supporters can back the program up to two years later at the level of their choice. This can include getting cGMP reagents at a discount, access to any data packages that were sent, and opt-in to being listed on the 510(k) or PMA submission.
- Bronze: Designed for labs that are starting to develop their UTI portfolio, this level has the minimal annual UTI reagent purchase commitment of $6K for three years. Bronze backers get access to data packages and can opt-in to being listed on a 510(k) or PMA submission.
- Silver: Designed for labs that intend to scale, this level has a moderate annual UTI reagent purchase commitment of $10K for two years. Importantly, any unused annual reagent purchase may be credited towards the following year (some limits apply). Silver backers get a 5% discount on UTI reagents, including any cleared assay, access to data packages and can opt-in to being listed on a 510(k) or PMA submission.
- Gold: Designed for medium size labs, this level has a moderate annual UTI reagent purchase commitment of $15K for two years. Importantly, any unused annual reagent purchase may be credited towards the following year (some limits apply). Gold backers get a 7.5% discount on UTI reagents, including any cleared assay, access to data packages and can opt-in to being listed on a 510(k) or PMA submission.
- Platinum: Designed for larger or regional labs that intend to expand, this level has an annual UTI reagent purchase commitment of $30K for two years. Importantly, any unused annual reagent purchase may be credited towards the following year (some limits apply). Platinum backers get a 10% discount on UTI reagents, including any cleared assay, access to data packages and can opt-in to being listed on a 510(k) or PMA submission.
- Diamond: Designed for larger or regional labs that want the maximum discount along with rewards, this level has an annual UTI reagent purchase commitment of $75K for two years. Importantly, any unused annual reagent purchase may be credited towards the following year (some limits apply). Diamond backers get a 15% discount on UTI reagents, including any cleared assay, access to data packages and can opt-in to being listed on a 510(k) or PMA submission.
Rewards
$5,000
Supporter Rewards: Ability to choose for two years backing at Bronze, Silver, Gold or Platinum levels. May not be used for “Early Backer” rewards. Backing: $5,000 per year for two years, invoiced annually. This amount may not be used to carry forward reagent credits. Project initiation contribution $5,000 (one-time charge at project initiation).
$6,000
Bronze Rewards: Access to cGMP reagents, access to any data packages, and opt-in to being listed on the 510(k) or PMA submission. This backing yields approximate analysis of 750 urine or equivalent samples per year at 15ul/reaction. Backing: $6,000 in UTI reagent purchase per year for three years, invoiced twice per year. This amount may not be used to carry forward reagent credits. Project initiation contribution $5,000 (one-time charge at project initiation).
$10,000
Early Backer Silver Rewards: Access to cGMP reagents, access to any data packages, and opt-in to being listed on the 510(k) or PMA submission. 7.5% discount on UTI reagents and any cleared UTI assay (limit 3 years). Note: $10,000 on UTI RUO reagents assays at a 7.5% discount yields approximate analysis of 1350 urine or equivalent samples per year at 15ul/reaction. Backing: $10,000 in UTI reagent purchase per year for two years, invoiced twice per year. Unused amounts may be credited and carried into the next year (where it must be used or lost). Project initiation contribution $5,000 (one-time charge at project initiation).
$10,000
Silver Rewards: Access to cGMP reagents, access to any data packages, and opt-in to being listed on the 510(k) or PMA submission. 5.0% discount on UTI reagents and any cleared UTI assay (limit 3 years). Note: $10,000 on UTI RUO reagents assays at a 5.0% discount yields approximate analysis of 1300 urine or equivalent samples per year at 15ul/reaction. Backing: $10,000 in UTI reagent purchase per year for two years, invoiced twice per year. Unused amounts may be credited and carried into the next year (where it must be used or lost). Project initiation contribution $5,000 (one-time charge at project initiation).
$15,000
Early Backer Gold Rewards: Access to cGMP reagents, access to any data packages, and opt-in to being listed on the 510(k) or PMA submission. 10.0% discount on UTI reagents and any cleared UTI assay (limit 3 years). Note: $15,000 on UTI RUO reagents assays at a 10.0% discount yields approximate analysis of 2080 urine or equivalent samples per year at 15ul/reaction. Lab name recognized on IFU. Backing: $15,000 in UTI reagent purchase per year for two years, invoiced twice per year. Unused amounts may be credited and carried into the next year (where it must be used or lost). Project initiation contribution $5,000 (one-time charge at project initiation).
$15,000
Gold Rewards: Access to cGMP reagents, access to any data packages, and opt-in to being listed on the 510(k) or PMA submission. Lab name recognized on IFU. 7.5% discount on UTI reagents and any cleared UTI assay (limit 3 years). Note: $15,000 on UTI RUO reagents assays at a 7.5% discount yields approximate analysis of 2025 urine or equivalent samples per year at 15ul/reaction. Backing: $15,000 in UTI reagent purchase per year for two years, invoiced twice per year. Unused amounts may be credited and carried into the next year (where it must be used or lost). Project initiation contribution $5,000 (one-time charge at project initiation).
$30,000
Platinum Rewards: Access to cGMP reagents, access to any data packages, and opt-in to being listed on the 510(k) or PMA submission. 10.0% discount on UTI reagents and any cleared UTI assay (limit 3 years). Note: $30,000 on UTI RUO reagents assays at a 10.0% discount yields approximate analysis of 4160 urine or equivalent samples per year at 15ul/reaction. Lab name recognized on IFU. Invitation to Gate Review. Lab name recognized on box. Backing: $30,000 in UTI reagent purchase per year for two years, invoiced quarterly. Unused amounts may be credited and carried into the next year (where it must be used or lost). Project initiation contribution $5,000 (one-time charge at project initiation).
$75,000
Diamond Rewards: Access to cGMP reagents, access to any data packages, and opt-in to being listed on the 510(k) or PMA submission. 15.0% discount on UTI reagents and any cleared UTI assay (limit 3 years). Note: $75,000 on UTI RUO reagents assays at a 15.0% discount yields approximate analysis of 11,030 urine or equivalent samples per year at 15ul/reaction. Lab name recognized on IFU. Invitation to Gate Review. Lab name recognized on box. Backing: $75,000 in UTI reagent purchase per year for two years, invoiced quarterly. Unused amounts may be credited and carried into the next year (where it must be used or lost). Project initiation contribution $5,000 (one-time charge at project initiation).
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This is an Update!
Thank you for your support so far!