From: Jessica Lin <jessica.lin@dnagenotek.com>
Sent: 7 August, 2020 15:46
To: Nino Gvenetadze <ngvenetadze@moh.gov.ge>
Cc: Lia Tavadze <ltavadze@moh.gov.ge>; Nino Kvernadze <ninokvernadze@moh.gov.ge>; Maia Alkhazashvili <M.Alkhazashvili@ncdc.ge>; Otar Namicheishvili <o.namicheishvili@ncdc.ge>; Natalie Godziashvili <ngodziashvili@moh.gov.ge>
Subject: Re: collection device OM-505 CRM:01941128

---== Email received from external source ==--

Dear Jessica,

Thank you for your email.

Please find responses to your questions below:

I’d be happy to provide you a formal quote for the devices mentioned below. I will require an official shipping and billing address, as well as phone number.

50,000 kits in a single shipment (if you want them in smaller shipments I will need the quantities and dates)? Do you have a deadline/timeline for when you are hoping to receive the kits?

Procurement procedures will be conducted in accordance with the World Bank Procurement Regulations. Meaning that we will officially provide you with an Invitation for Direct Contracting of Goods, which is the World Bank standard document, and you will have the possibility to submit your offer officially later.

Meanwhile, you are kindly asked to share with us only updated invoice for 50 000 kits including the transportation fees - CIP Tbilisi International Airport.

50, 000 kits in a single shipment will be perfect.  As for deadline, it would be appreciated to receive goods as early as you can.  Please share with us your estimate timeline.

The payment terms will depend on where the funds are coming from. I had initially checked for the Georgian National Center for Disease Control & Public Health (99 Kakheti Highway, Tbilisi 0198, Georgia) and this account is approved for Net30 terms. If the billing account is different, I will have to check with our finance team and let you know if we will require pre-payment.

Please be noted that the World Bank finances the Emergency COVID-19 Response project and following the Project Agreement between parties, the implementing Agency of the project is the Ministry of Internally Displaced Persons from the Occupied Territories, Labour, Health and Social Affairs of Georgia. 

All public institutions accounts are opened in the State Treasury. Accordingly, all transfers are supported by NBG (National Bank of Georgia) and State Treasury of Ministry of Finance of Georgia (MOF)

Hope it will clarify the issue.

Furthermore, I would like to check with you if the Georgian government has any requirements for the markings on the collection devices. The ORE-100 devices are CE-IVD cleared, whereas the OM-505 devices are RUO (research use only) marked. We have RUO and CE-IVD options for both formats. Some institutions don’t have a preference, however I’d like to check before the kits are sent so there are no issues upon import or when processing samples.

We prefer CE-IVD options, if available.

Are these kits being mailed from donors’ homes to a clinic? If so, you may require bio specimen bags: https://www.dnagenotek.com/ROW/products/accessories/mailing-accessories/MO-3.html.

Please let me know if you would like these added to the quote.

You are kindly asked to add  to the quote bio specimen bags.

your prompt feedback will be highly appreciated

Best,

პატივისცემით,

ნინო გვენეტაძე

შესყიდვების კონულტანტი,

მსოფლიო ბანკის COVID-19-ის წინააღმდეგ სწრაფი რეაგირების პროექტი.

საქართველოს ოკუპირებული ტერიტორიებიდან დევნილთა, შრომის, ჯანმრთელობისა და სოციალური დაცვის სამინისტრო 

www.moh.gov.ge  

Nino Gvenetadze

Procurement Consultant, PIU – World Bank

Emergency COVID-19 Response Project.

Ministry of Internally Displaced Persons from the Occupied Territories, Labour, Health and Social Affairs of Georgia

www.moh.gov.ge 

Email: ngvenetadze@moh.gov.ge

Cell: +995 5 99 78 84 24

Hi Nino,

Thanks for reaching out, it’s nice to e-meet you!

I’d be happy to provide you a formal quote for the devices mentioned below. I will require an official shipping and billing address, as well as phone number. Will you require all 50,000 kits in a single shipment (if you want them in smaller shipments I will need the quantities and dates)? Do you have a deadline/timeline for when you are hoping to receive the kits?

The payment terms will depend on where the funds are coming from. I had initially checked for the Georgian National Center for Disease Control & Public Health (99 Kakheti Highway, Tbilisi 0198, Georgia) and this account is approved for Net30 terms. If the billing account is different I will have to check with our finance team and let you know if we will require pre-payment.

Furthermore, I would like to check with you if the Georgian government has any requirements for the markings on the collection devices. The ORE-100 devices are CE-IVD cleared, whereas the OM-505 devices are RUO (research use only) marked. We have RUO and CE-IVD options for both formats. Some institutions don’t have a preference, however I’d like to check before the kits are sent so there are no issues upon import or when processing samples.

Are these kits being mailed from donors’ homes to a clinic? If so, you may require biospecimen bags: https://www.dnagenotek.com/ROW/products/accessories/mailing-accessories/MO-3.html. Please let me know if you would like these added to the quote.

If the lab requires any feedback or support in regards to how to process the samples, I’d be happy to provide information.

You may receive an out of office message from me as I’m off this week, however I will continue to handle this request personally so not to worry.

Regards,

Jessica

From: Nino Gvenetadze <ngvenetadze@moh.gov.ge>
Sent: August-03-20 4:01 PM
To: Jessica Lin <jessica.lin@dnagenotek.com>
Cc: Lia Tavadze <ltavadze@moh.gov.ge>; Nino Kvernadze <ninokvernadze@moh.gov.ge>; Maia Alkhazashvili <M.Alkhazashvili@ncdc.ge>; Otar Namicheishvili <o.namicheishvili@ncdc.ge>
Subject: RE: collection device OM-505 CRM:01941128

Dear Jessica,

Hope this email finds you well.

My name is Nino Gvenetadze, I am a procurement consultant of the PIU, operating under the Ministry of Internally Displaced Persons from the Occupied Territories, Labour, Health and Social Affairs of Georgia for the Emergency COVID-19 Response project.  The project is financed by the World Bank and procurement procedures will be conducted in accordance with the World Bank Procurement Regulations.

Considering above, I address you on behalf of  the Ministry regarding the purchasing of saliva collection devises. As Ms. Maia Alkhazashvili mentioned from now on, PIU will be in charge of all procurement procedures.  

We are very glad that our colleges have already launched the process and I am pretty sure that we will proceed with it successfully.

Please be noted, that it was decided to increase the purchase order quantity p to 50 000 kits (OM-505 OMNI gene ORAL for microbial DNA and RNA – 25 00 kits and  ORE-100 ORE- 100 ORA collect RNA 25 000 kits).

Accordingly,  you are kindly  asked  to share with us an updated invoice for 50 000  kits of each type including the transportation fees.

Thank you in advance for your cooperation. Your prompt reply will be highly appreciated.

Best,

პატივისცემით,

ნინო გვენეტაძე

შესყიდვების კონულტანტი,

მსოფლიო ბანკის COVID-19-ის წინააღმდეგ სწრაფი რეაგირების პროექტი.

საქართველოს ოკუპირებული ტერიტორიებიდან დევნილთა, შრომის, ჯანმრთელობისა და სოციალური დაცვის სამინისტრო 

www.moh.gov.ge  

Nino Gvenetadze

Procurement Consultant, PIU – World Bank

Emergency COVID-19 Response Project.

Ministry of Internally Displaced Persons from the Occupied Territories, Labour, Health and Social Affairs of Georgia

www.moh.gov.ge 

Email: ngvenetadze@moh.gov.ge

Cell: +995 5 99 78 84 24

Dear Jessica,

As I already mentioned that we will procure the saliva collection devises trough the World bank. I copied two persons into the conversation. They are responsible for the world bank procurement procedures. So they will continue working with you.

Thank you for your kindly support.

Best regards,

Maia

Hi Maia,

Any updates from your end?

Regards,

Jessica

Hi Maia,

Thanks for letting me know. Please keep me in the loop with any updates. The earlier we know the number of kits you need, and when you will need them, the faster we can get them to you.

Regards,

Jessica

From: Maia Alkhazashvili <M.Alkhazashvili@ncdc.ge>
Sent: July-09-20 3:21 PM
To: Jessica Lin <jessica.lin@dnagenotek.com>
Subject: RE: collection device OM-505

Dear Jessica,

Yes of course I am interested in these devises.

I am just checking funds and I am going to increase the amounts.  

Maia

Hi Maia,

Are the devices still of interest to you? If not, please let me know so I’m aware of the situation.

Regards,

Jessica

Hi Maia,

Just wanted to get an update as to how things are going with the pilot project approvals. Any updates would be greatly appreciated.

Regards,

Jessica

Hi Maia,

Any updates as per the approvals?

Regards,

Jessica

Sorry Maia, I have attached an update quote with the correct shipping cost. The currency hadn’t yet been exchanged to the correct one.

Regards,

Jessica

Hi Maia,

Please see formal quote attached. To place the order you can either sign the quote or provide a purchase order against the quote number.

Our freight forwarders had a hard time finding an airline that would ship to this location, so the shipping costs are higher than usual. If you have an account with a preferred courier we can ship under your account.

I checked with our finance team and we can ship the kits and receive payment at Net30 conditions (30 days to make payment from ship date).

Do you have an estimation of when you will get approvals and place the order? Like I mentioned, due to high demand I want to ensure we have these kits available when you need them.

Regards,

Jessica

Thanks Maia. I will work on the formal quote for you now. I have requested a shipping quote from our logistics department, and hopefully I hear from them by the end of the day today. When are you hoping to place the order for the kits? It would be helpful to get an estimated date so we can plan to have these kits available for you. We have extremely high demand at the moment and I want to ensure you get the devices you need in a timely manner.

I have also submitted a request to finance for a credit check to see if we will be able to send the shipment without pre-payment. What is the reasoning on your end that payment should be submitted following receipt of goods?

Regards,

Jessica

From: Maia Alkhazashvili <M.Alkhazashvili@ncdc.ge>
Sent: June-22-20 10:46 AM
To: Jessica Lin <jessica.lin@dnagenotek.com>
Subject: RE: collection device OM-505

Dear Jasika,

Here you can find a shipping and billing address:

National Center for Disease Control & Public Health

99 Kakheti Highway, Tbilisi 0198, Georgia

Regards,

Maia

Hi Maia,

So you will take a formal quote from us and propose it to the ministry of finance for approvals? I will require a shipping and billing address for the quote.

When do you expect to get approval from the ministry and when will you require the 2,500 devices? Are you looking for the OM-505 saliva format or the ORE-100 swab/sponge format?

If your results are reliable with the initial 2,500 devices, when do you expect to require the 25,000 devices and is this a monthly requirement?

Regards,

Jessica

From: Maia Alkhazashvili <M.Alkhazashvili@ncdc.ge>
Sent: June-19-20 5:02 PM
To: Jessica Lin <jessica.lin@dnagenotek.com>
Subject: RE: collection device OM-505

Dear Jessica,

Thank you for the offer.

First of all I would like to mention  we are the governmental organization and accordingly we need to sign contact and negotiate with the ministry of finance.

Are you able to prepare the invoice for 2500 kits of each type including transportation fees. We will prepare the contract and send  you for revision.

Please take into consideration that preliminary payment from our site is problematic. We will pay next day after product’s delivery. I hope this will be acceptable.

In addition, if we get the reliable results, our monthly demand will be more than 25000 kits based on the availability.

Thank you in advance.

Maia

Maia Alkhazashvili, MD

Head of Lugar Center  

R. Lugar Center for Public Health Research

National Center for Disease Control & Public Health

99 Kakheti Highway, Tbilisi 0198, Georgia

Office phone: (995 32) 219 25 95 ext. 900

Cell phone: 995 577 411 005

e-mail:  doctormaiko@gmail.com

              m.alkhazashvili@ncdc.ge

Hi Maia,

Thanks for the overview of your plans.

I’m able to send you 4 samples of each kit (ORE-100 and OM-505) to evaluate. If you would like to evaluate a larger number of samples, please let me know the number and I can provide you a price quote.

These are our pricing tiers for COVID-19 related applications. As you can see, pricing is equal for both formats so you can base your decision on format best suited for your assay, not price.

As you may already know, these kits are suitable for at-home testing and do not require supervision. The FDA has recently released guidelines on transport media for SARS-CoV-2 stating that buffers containing guanidinium are unsafe: https://www.fda.gov/medical-devices/letters-health-care-providers/transport-media-safety-risk-use-compatible-transport-media-sars-cov-2-tests-use-bleach-letter?utm_campaign=2020-06-04%20Transport%20Media%20Safety%20Risk%20Letter%20to%20Health%20Care%20Providers&utm_medium=email&utm_source=Eloqua. DNA Genotek products do not use guanidinium, unlike many other reagents available, and are therefore safe for handling.

Furthermore, we have data proving immediate inactivation of the SARS-CoV-2 virus, enabling safer handling of samples: https://www.dnagenotek.com/ROW/pdf/MK-01430.pdf.

What is your timeline for evaluation of the saliva kits? If you choose to move forward with these kits, will your demand be 8,000 per month? When are you hoping to start with saliva collections?

Regards,

Jessica

From: Maia Alkhazashvili <M.Alkhazashvili@ncdc.ge>
Sent: June-16-20 3:53 PM
To: Jessica Lin <jessica.lin@dnagenotek.com>
Subject: RE: collection device OM-505

Dear Jessica,

Thank you for you feedback.

Georgia started testing from February. Detailed information you can see on our website. https://www.ncdc.ge/Pages/User/News.aspx?ID=4d01df7c-43dc-4603-bce6-0bf9478fea3b&language=en-US

Lugar Center is the reference laboratory in the country and we are responsible for all Laboratory network and diagnostic of Covid19 as well.

Our Lab is the part of NCDC and we are making all recommendations, testing protocols and etc.

Today we are doing about 2000  SarsCov2 PCR tests daily using swab samples.

First of all we need to evaluate some different methods using saliva samples and based on that will decide to use this method widely.

In addition I am interesting about the price and delivery time after the order will be placed.

Thanks,

Maia

Maia Alkhazashvili, MD

Head of Lugar Center  

R. Lugar Center for Public Health Research

National Center for Disease Control & Public Health

99 Kakheti Highway, Tbilisi 0198, Georgia

Office phone: (995 32) 219 25 95 ext. 900

Cell phone: 995 577 411 005

e-mail:  doctormaiko@gmail.com

              m.alkhazashvili@ncdc.ge

Hi Maia,

I’ll be your point of contact for our molecular products in Georgia, it’s nice to e-meet you!

As Laura mentioned, our OM-505 device was recently given an EUA in conjunction with P23 Labs’ TaqPath SARS-CoV-2 assay. Our ORE-100 device is also suitable for COVID applications, and is priced the same as the OM-505, so the choice will be dependant on the format you prefer, or a combination of both.

Our ORE-100 (https://www.dnagenotek.com/ROW/products/collection-human/oracollect-rna/ORE-100.html) is the sponge based collector that will yield a sample volume of ~750uL. The OM-505 oral microbiome kit (https://www.dnagenotek.com/ROW/products/collection-microbiome/omnigene-oral/OM-505.html) has a 2mL sample volume (1mL saliva + 1mL stabilizing chemistry).

®     What is the quantity you will require on a weekly or monthly basis, and over what time period do you foresee collections?

®     When are you hoping to start testing?

®     Are you evaluating any other methods?

Regards,

Jessica

Register here for a webinar on how to overcome sample collection challenges during COVID-19

_____________________________

Jessica Lin HBSc.| Account Manager

DNA Genotek  | Superior Samples ● Proven Performance

3000-500 Palladium Drive, Ottawa, ON Canada K2V 1C2

jessica.lin@dnagenotek.com | www.dnagenotek.com |

Direct: +1.613.723.5757 x 2238 | Toll Free 1.866.813.6354 x 2238  | Fax 1.613.723.5057

Visit our blogs, The Microbiome Snapshot and The Genetic Link at http://blog.dnagenotek.com

If you would like to opt out of email from DNA Genotek, you can unsubscribe HERE

Thanks Geoff!

Dear Maia,

Thank you for reaching out. I would also like to e-introduce you to our colleague Jessica (copied here) who is the Account Manager responsible for Georgia. Jessica will be able to provide you with the relevant information and details on how to order our saliva products.

Both ORE-100 and OM-505 are suitable for use with TaqPath SARS-CoV-2 Assays. For quick reference here is the EUA (P23 Labs) using the OM-505 device: https://www.fda.gov/media/138295/download

Jessica will be in touch shortly.

Kind regards,
Laura

Dear Maia,

I am connecting you with Laura Cunningham, the Product Manger for our molecular collection devices.  She will be able to help you with your enquiry.

Laura, Dr. Maia Alkhazashvili, Head of the Lugar Center @ Georgia NCDC, is interested in pairing the Ora Collect device with TaqPath SARS-COV-2.  Could you help?

Thanks,

Geoff

Geoff Graham, MEng, MPH | Senior Product Manager, Infectious Disease 
DNA Genotek, a subsidiary of OraSure Technologies | Superior Samples ● Proven Performance

3000 - 500 Palladium Dr, Ottawa, ON Canada K2V 1C2

geoffrey.graham@dnagenotek.com | www.dnagenotek.com

Toll-Free: 1-866-813-6354 x 2263 | Direct: 1-613-254-8163 | Fax: 1-613-723-5057

From: Maia Alkhazashvili <M.Alkhazashvili@ncdc.ge>
Sent: 15 June 2020 11:10
To: Geoffrey M. Graham <geoffrey.graham@dnagenotek.com>
Subject: collection device OM-505

Dear Geoffrey,

I would like to ask you about the collection device - ORA collect RNA And OM-505. We are using TaqPath SARS-CoV-2 Assay for the covid diagnostic.As I know saliva collection device got EUA from the FDA.  So we would like to use the saliva samples as well

Can you help us to get the ordering information. We will be able also to buy directly from the company.

Thank you in advance.

Best regards,

Maia

Maia Alkhazashvili, MD

Head of Lugar Center  

R. Lugar Center for Public Health Research

National Center for Disease Control & Public Health

99 Kakheti Highway, Tbilisi 0198, Georgia

Office phone: (995 32) 219 25 95 ext. 900

Cell phone: 995 577 411 005

e-mail:  doctormaiko@gmail.com

              m.alkhazashvili@ncdc.ge

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The information contained in this e-mail message and any attachment hereto is legally privileged and confidential information intended only for the use of the individual(s) named above. If the reader of this message is not an intended recipient, you are hereby notified that any use, dissemination, distribution or copying of this e-mail message and any attachment hereto is strictly prohibited. If you have received this e-mail message in error, please immediately notify the above-noted sender by telephone and erase all copies of this message from your computer. Thank you for your cooperation.

The information contained in this e-mail message and any attachment hereto is legally privileged and confidential information intended only for the use of the individual(s) named above. If the reader of this message is not an intended recipient, you are hereby notified that any use, dissemination, distribution or copying of this e-mail message and any attachment hereto is strictly prohibited. If you have received this e-mail message in error, please immediately notify the above-noted sender by telephone and erase all copies of this message from your computer. Thank you for your cooperation.