PANDAA HIVDR Evaluations
In 2014, we founded Aldatu with the explicit mission of developing diagnostics that would enable universal access to HIV drug resistance genotyping.
In 2024, we want you to put that to the test.
Join an international collaboration with the unique opportunity to answer questions that will shape the discussions to make that a reality.Â
Through our NIH funding, we aim to distribute thousands of our PANDAA HIVDR tests to international partners in early 2024. Kits are provided at no cost to you.
Proposed Panel
PANDAA HIVDR assays are modular in design, allowing the rapid reconfiguration of the panel prior to launch.
| HIV Target Region | PANDAA DRMs |
|---|---|
| Integrase | 118R, 148HKR, 155H, 263K |
| Protease | 47AV, 50LV, 76V, 82AFT, 84V, 88S |
| Reverse Transcriptase | 65R, 184VI |
14 patients can be genotyped for >18 DRMs in under 4 hours, giving you information on:
- Resistance to dolutegravir, helping you identify patients with adherence issues.
- Susceptibility to darunavir, getting patients on the right alternative therapy quickly.
- Resistance to both lopinavir and atazanavir.
Find out more about PANDAA: www.aldatubio.com/hivdr
by World AIDS Day 2023
January 2024
from
March 2024
Register your interest in participating, and provide feedback on the proposed DRMs to be genotyped by the PANDAA HIVDR panel.
Final PANDAA HIVDR panel design released to collaborators and discussion with individual partners on study design, shipping logistics etc.Â
PANDAA HIVDR genotyping panel and training kits distributed.
What matters most to you?
Understanding your priorities will enable us to provide the best HIVDR testing solution.
-
DRM coverage
-
Turnaround time
-
Ease of use (i.e., number of hands on steps)
-
Throughput (number of samples per run)
-
Cost
-
Potential for decentralisation
by World AIDS Day 2023
Register your interest in participating, and provide feedback on the proposed DRMs to be genotyped by the PANDAA HIVDR panel.
January 2024
Final PANDAA HIVDR panel design released to collaborators and discussion with individual partners on study design, shipping logistics etc.Â
from March 2024
PANDAA HIVDR genotyping panel and training kits distributed.
What matters most to you?
Features of Focussed Genotyping
-
DRM coverage
-
Turnaround time
-
Ease of use (i.e., number of hands on steps)
-
Throughput (number of samples per run)
-
Cost
-
Potential for decentralisation
How to participate
There are several ways in which you can contribute. We encourage you to email us to discuss other ways in which we can collaborate: HIVDR@aldatubio.com
There are several ways in which you can contribute. This is a collaborative effort, so we encourage you to reach out if you’re unsure: HIVDR@aldatubio.com
This is the preferred option as it will provide the most comprehensive feedback regarding the implementation of PANDAA in your resistance testing lab. You can used residual viral RNA from viral load testing or Sanger sequencing, or extract fresh RNA.
It will be important to track the quality of the RNA [e.g., freeze/thaw of samples, time since RNA extraction etc.]
If you have banked PCR amplicon from previous Sanger sequencing—or you will have insufficient sample / RNA to also perform PANDAA resistance genotyping—then you can use the PCR amplicon for PANDAA. You simply skip the PANDAA PreAmp step.
If you do not have access to a real-time PCR machine, you can still participate by shipping the PANDAA PreAmp product or PCR amplicon to Aldatu in Boston, USA. We'll do the PANDAA genotyping for you.
Shipping PANDAA PreAmp product or amplicon is easy: simply add the samples to a 96-well plate, which can be shipped at ambient temperature in the mail. No dry ice required.
Register your interest
and / or Provide feedback on panel design.
Time burden: <5 minutes. You will not be added to any email marketing lists.
FAQs
or email: HIVDR@aldatubio.com
What is focused genotyping?
In contrast to resource-intensive approaches such as Sanger sequencing, focused genotyping is a resistance testing approach that identifies a subset of key drug resistance mutations (DRMs) that are indicative of intermediate or high-level acquired drug resistance in the majority of patients failing a specific ART regimen.
With the same sensitivity as population sequencing, PANDAA HIVDR assays rapidly detect actionable drug resistance mutations in the reverse transcriptase, protease, and integrase genes of HIV-1 that affect susceptibility to the NRTI, NNRTI, PI and INSTI drug classes.
With the same sensitivity as population sequencing, PANDAA HIVDR assays rapidly detect actionable drug resistance mutations in the reverse transcriptase, protease, and integrase genes of HIV-1 that affect susceptibility to the NRTI, NNRTI, PI and INSTI drug classes.
What is PANDAA PreAmp?
PreAmp is a rigorously validated RT-PCR-based approach for the consistent and unbiased amplification of the HIV pol gene.
PreAmp generates sufficient product from low copy RNA samples for multiple downstream PANDAA HIVDR assays, while minimizing SNP frequency biasing and cross-contamination that could result from over-amplification. PreAmp generates sufficient sample material for >40 PANDAA HIVDR assays.
PANDAA PreAmp can be stored for several weeks at 4°C with no loss in sensitivity, and no sample cleanup is required before using PANDAA PreAmp in downstream applications.
PreAmp generates sufficient product from low copy RNA samples for multiple downstream PANDAA HIVDR assays, while minimizing SNP frequency biasing and cross-contamination that could result from over-amplification. PreAmp generates sufficient sample material for >40 PANDAA HIVDR assays.
PANDAA PreAmp can be stored for several weeks at 4°C with no loss in sensitivity, and no sample cleanup is required before using PANDAA PreAmp in downstream applications.
What will be provided?
Each PANDAA PreAmp kit is sufficient for 48 reactions, and each PANDAA HIVDR kit covers 14 patient samples and two controls [16 samples]. We will send as many kits as you think is necessary for your work. Additionally, we will provide training kits of synthetic RNA for lab staff to practice the PANDAA HIVDR workflow before working with samples.
To make shipping and storage as efficient as possible, our kits are very small: 8.25cm x 8.25cm x 3.5cm. Given the cost of shipping internationally on dry ice, it is preferable to send you all your kits at once.
To make shipping and storage as efficient as possible, our kits are very small: 8.25cm x 8.25cm x 3.5cm. Given the cost of shipping internationally on dry ice, it is preferable to send you all your kits at once.
Will training be provided?
Yes! PANDAA HIVDR genotyping kits will be sent with Training Kits that are made up of non-infectious synthetic DNA covering the target reverse transcriptase, protease and integrase regions in the pol gene of HIV-1.
Virtual training will be provided, and with sufficient interest from participants, there may be the opportunity for in-person training in your country.
Virtual training will be provided, and with sufficient interest from participants, there may be the opportunity for in-person training in your country.
What is not provided?
Our NIH funding is only able to cover the costs of manufacturing and distributing the PANDAA HIVDR kits to our collaborators. We are unable to support any new studies, the cost of sample extraction or any overheads. PANDAA HIVDR evaluations would have to integrate into existing work.
What equipment do I need?
You will need to capabilities to extraction nucleic acid from your samples, and a real-time PCR machine. PANDAA is platform-agnostic, so it is compatible with all major real-time PCR models.
If you are sending your amplicon / PANDAA PreAmp to Aldatu for PANDAA genotyping, you will still need to be able to extract your sample.
If you are sending your amplicon / PANDAA PreAmp to Aldatu for PANDAA genotyping, you will still need to be able to extract your sample.
Who will own the data?
If it is your first time using PANDAA, we'll assist you in interpreting the data (it's very easy). We feel very strongly about data ownership so that you have the freedom to present and publish your results.
How will the kits be shipped and stored?
The PANDAA HIVDR kit is shipped on dry ice and the kit components will arrive frozen. All components should be stored between -25°C and -15°C upon arrival. After thawing, the reagents can be stored between 2°C and 8°C for up to 48 hours. More than two freeze-thaw cycles of the reagents should be avoided to ensure assay performance.
How to participate
There are several ways in which you can contribute. This is a collaborative effort, so we encourage you to reach out if you’re unsure: HIVDR@aldatubio.com
Option #1: perform the entire PANDAA HIVDR workflow from sample to answer in your lab.
This is the preferred option as it will provide the most comprehensive feedback regarding the implementation of PANDAA in your resistance testing lab. You can used residual viral RNA from viral load testing or Sanger sequencing, or extract fresh RNA.
It will be important to track the quality of the RNA [e.g., freeze/thaw of samples, time since RNA extraction etc.]
Option #2: use stored PCR amplicon to genotype with PANDAA HIVDR.
If you have banked PCR amplicon from previous Sanger sequencing-or you will have insufficient sample / RNA to also perform PANDAA resistance genotyping-then you can use the PCR amplicon for PANDAA. You simply skip the PANDAA PreAmp step.
Option #3: send your PCR amplicon or PANDAA PreAmp to Aldatu for genotyping by PANDAA.
If you do not have access to a real-time PCR machine, you can still participate by shipping the PANDAA PreAmp product or PCR amplicon to Aldatu in Boston, USA. We’ll do the PANDAA genotyping for you.
Shipping PANDAA PreAmp product or amplicon is easy: simply add the samples to a 96-well plate, which can be shipped at ambient temperature in the mail. No dry ice required.
FAQs
or email HIVDR@aldatubio.com
What is focused genotyping?
In contrast to resource-intensive approaches such as Sanger sequencing, focused genotyping is a resistance testing approach that identifies a subset of key drug resistance mutations (DRMs) that are indicative of intermediate or high-level acquired drug resistance in the majority of patients failing a specific ART regimen.
Â
With the same sensitivity as population sequencing, PANDAA HIVDR assays rapidly detect actionable drug resistance mutations in the reverse transcriptase, protease, and integrase genes of HIV-1 that affect susceptibility to the NRTI, NNRTI, PI and INSTI drug classes.
What will be provided?
Each PANDAA PreAmp kit is sufficient for 48 reactions, and each PANDAA HIVDR kit covers 14 patient samples and two controls [16 samples]. We will send as many kits as you think is necessary for your work. Additionally, we will provide training kits of synthetic RNA for lab staff to practice the PANDAA HIVDR workflow before working with samples.
Â
To make shipping and storage as efficient as possible, our kits are very small: 8.25cm x 8.25cm x 3.5cm. Given the cost of shipping internationally on dry ice, it is preferable to send you all your kits at once.
What is not be provided?
Our NIH funding is only able to cover the costs of manufacturing and distributing the PANDAA HIVDR kits to our collaborators. We are unable to support any new studies, the cost of sample extraction or any overheads. PANDAA HIVDR evaluations would have to integrate into existing work.
What is PANDAA PreAmp?
PreAmp is a rigorously validated RT-PCR-based approach for the consistent and unbiased amplification of the HIVÂ pol gene.Â
Â
PreAmp generates sufficient product from low copy RNA samples for multiple downstream PANDAA HIVDR assays, while minimizing SNP frequency biasing and cross-contamination that could result from over-amplification. PreAmp generates sufficient sample material for >40 PANDAA HIVDR assays.
Â
PANDAA PreAmp can be stored for several weeks at 4°C with no loss in sensitivity, and no sample cleanup is required before using PANDAA PreAmp in downstream applications.
Who will own the data?
You. If it is your first time using PANDAA, we’ll assist you in interpreting the data (it’s very easy). We feel very strongly about data ownership so that you have the freedom to present and publish your results.
What equipment do I need?
You will need to capabilities to extraction nucleic acid from from your samples, and a real-time PCR machine. PANDAA is platform-agnostic, so it is compatible with all major real-time PCR models.
Â
If you are sending your amplicon / PANDAA PreAmp to Aldatu for PANDAA genotyping, you will still need to be able to extract your sample.