[Mmcap_list] FW: MMCAP Infuse - Covid19 Testing Info

Fri Apr 3 09:14:29 PDT 2020

SEE EMAIL FROM KIM HANKINS AND RELATED ATTACHMENTS.

Lori Doke, CPPB, OPBC, CTAC
State Procurement Analyst
DAS-EGS Procurement Services
C - (971)  719-1627

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************************************

From: Hankins, Kim (ADM) <kim.hankins at state.mn.us>
Sent: Friday, April 03, 2020 9:08 AM
To: Hankins, Kim (ADM) <kim.hankins at state.mn.us>
Subject: MMCAP Infuse - Covid19 Testing Info

Good Morning,

Hope this finds you well.  I wanted to provide some updates on what we know regarding testing.  The FDA approved Abbott ID NOW test is not distributed by MCMAP Infuse vendors.  FEMA is coordinating with your ESF8 on distribution to my best understanding.  Several companies have provided an antibody rapid blood test, like the Premier Biotech test, which has been used as a screening tool.  Henry Schein announced their version on 3/23 and mentioned in the President's Rose Garden speech this past Sunday, link to Henry Schein's website below (an amendment to include this product on the MMCAP Infuse MMS18016 contract is pending.)  Our other vendor, Concordance, has a product from JANT Pharma that is a similar screening tool.  I have attached our contract amendment along with the package insert for information.  Below, I provided a summary of Concordance ordering details (note the payment/delivery) and I also provided the Concordance sales rep contact information.

Concordance:
[cid:image001.png at 01D60994.7AFBF230]
Marie Neubert | Senior Corporate Account Manager
Concordance Healthcare Solutions - New Rochelle, NY
914-819-1120 | mneubert at concordancehs.com<https://gcc01.safelinks.protection.outlook.com/?url=http%3A%2F%2Fmneubert%40concordancehs.com%2F&data=02%7C01%7Ckim.hankins%40state.mn.us%7C926ca5b46190497511f608d7d7e4c134%7Ceb14b04624c445198f26b89c2159828c%7C0%7C0%7C637215250742381983&sdata=Yq4yOAoRwUMnWxe%2BANhxpQOFlXr%2BBwJan%2F6vGt2DIcU%3D&reserved=0>
Mobile: 516-996-5262

Henry Schein:
https://www.henryschein.com/us-en/medical/resource-center/coronavirus.aspx?adDivision=&adId=100523&PromoCode=&PromoCode2=&DP=False&cm_sp=Custom%20Ads-_-MEDICAL_January2020-_-me0120_266_us-en_z38+Henry%20Schein%20Promotions+Coronavirus%20and%20infection%20prevention%20products<https://gcc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.henryschein.com%2Fus-en%2Fmedical%2Fresource-center%2Fcoronavirus.aspx%3FadDivision%3D%26adId%3D100523%26PromoCode%3D%26PromoCode2%3D%26DP%3DFalse%26cm_sp%3DCustom%2520Ads-_-MEDICAL_January2020-_-me0120_266_us-en_z38%2BHenry%2520Schein%2520Promotions%2BCoronavirus%2520and%2520infection%2520prevention%2520products&data=02%7C01%7Ckim.hankins%40state.mn.us%7C926ca5b46190497511f608d7d7e4c134%7Ceb14b04624c445198f26b89c2159828c%7C0%7C0%7C637215250742391977&sdata=BHmUkQdNtpaSAP5zLJ%2FVFDi9l9OxGkpyCuV5G4gsO48%3D&reserved=0>

MMCAP Infuse has executed a contract amendment with Premier Biotech (contract # MMS14028) to offer COVID-19 testing kits.  This is a rapid blood test which takes 10 minutes for results.  I have attached a document describing the product.

The tests are $7.00 per device (cases of 60.)  Below is Sam Wilczyk contact information along with Premier Biotech's customer service.  They have the ability to review our roster of MMCAP Infuse id#'s so make sure to let them know you are a member so they will provide you our contracted pricing.

These tests are authorized by the FDA, but are not yet approved, since the accuracy has not been tested. In its effort to expedite the process of getting Point of Care test kits to facilities, the FDA waived the CLIA certification and allowed use of the kits.  Sam/Premier Biotech can address the distinction better than I can.

Sam Wilczyk
Director of Government Solutions
Premier Biotech, Inc.
723 Kasota Avenue SE
Minneapolis, MN 55414
Direct: 612-300-3134
swilczyk at premierbiotech.com<mailto:swilczyk at premierbiotech.com>
www.premierbiotech.com<https://gcc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fapp.salesforceiq.com%2Fr%3Ftarget%3D5e752500c9e77c007862bc6f%26t%3DAFwhZf0GiF_jtXBQX9eiMiia6XR-8w7-4GrBW68Kym3GAB3MFlSkc2wWjYpO7WhhEtquJXWq8HymEY_YtHjon_zRWbevxzA4p58VLCDjdK4bcDKza0gQacknA5d99yLqMFjba--l09tb%26url%3Dhttp%253A%252F%252Fwww.premierbiotech.com%252F&data=02%7C01%7Ckim.hankins%40state.mn.us%7C926ca5b46190497511f608d7d7e4c134%7Ceb14b04624c445198f26b89c2159828c%7C0%7C0%7C637215250742401970&sdata=tjH5OH%2B6uoa%2Fb%2BolRQqsFGgrKBGB9oVoS8ldaPD%2B1KU%3D&reserved=0>

Orders at premierbiotech.com<mailto:Orders at premierbiotech.com>

Customer Service 888-686-9909
These tests are authorized by the FDA, but are not yet approved, since the accuracy has not been tested. In its effort to expedite the process of getting Point of Care test kits to facilities, the FDA waived the CLIA certification and allowed use of the kits.  FDA issued a policy stating that these types of blood tests can be distributed without formal FDA approval, as long as other recommendations are met.  See Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency," available at:  https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-diagnostic-tests-coronavirus-disease-2019-during-public-health-emergency<https://gcc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Furldefense.proofpoint.com%2Fv2%2Furl%3Fu%3Dhttps-3A__www.fda.gov_regulatory-2Dinformation_search-2Dfda-2Dguidance-2Ddocuments_policy-2Ddiagnostic-2Dtests-2Dcoronavirus-2Ddisease-2D2019-2Dduring-2Dpublic-2Dhealth-2Demergency%26d%3DDwMGaQ%26c%3DsdnEM9SRGFuMt5z5w3AhsPNahmNicq64TgF1JwNR0cs%26r%3DtfvB9GIfwa5UrVz7Q6FDUN2MqD7j9Ks3u0Nj3joAjhc%26m%3Ds-Xqe81RI7009L6G2avoGkhZUgeWM7W6RxVqu2PWEAE%26s%3DxSzRqAzNqHL-IzJBDzWZtzpAhqaHxtmiKndnaldSt_I%26e%3D&data=02%7C01%7Ckim.hankins%40state.mn.us%7C9d3945c5f15148e3007a08d7d681e439%7Ceb14b04624c445198f26b89c2159828c%7C0%7C0%7C637213726093389193&sdata=2impdRaro%2FSLGwKq%2BnMkBW6jnqTBGamsDqPkhHCa6Jc%3D&reserved=0>.   The tests are being marketed based on FDA's new policy.  See FDA Website, https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-diagnostic-testing-sars-cov-2?utm_campaign=2020-03-20%20Mar%2020%20Update%3A%20New%20Information%20on%20Diagnostic%20Testing%20for%20SARS-CoV-2&utm_medium=email&utm_source=Eloqua#whatserologytest<https://gcc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Furldefense.proofpoint.com%2Fv2%2Furl%3Fu%3Dhttps-3A__www.fda.gov_medical-2Ddevices_emergency-2Dsituations-2Dmedical-2Ddevices_faqs-2Ddiagnostic-2Dtesting-2Dsars-2Dcov-2D2-3Futm-5Fcampaign-3D2020-2D03-2D20-2520Mar-252020-2520Update-253A-2520New-2520Information-2520on-2520Diagnostic-2520Testing-2520for-2520SARS-2DCoV-2D2-26utm-5Fmedium-3Demail-26utm-5Fsource-3DEloqua-23whatserologytest%26d%3DDwMGaQ%26c%3DsdnEM9SRGFuMt5z5w3AhsPNahmNicq64TgF1JwNR0cs%26r%3DtfvB9GIfwa5UrVz7Q6FDUN2MqD7j9Ks3u0Nj3joAjhc%26m%3Ds-Xqe81RI7009L6G2avoGkhZUgeWM7W6RxVqu2PWEAE%26s%3D7H6hv4w1JmoZlF872QfoDcvqDZOtV6OlPltXfQgpZqA%26e%3D&data=02%7C01%7Ckim.hankins%40state.mn.us%7C9d3945c5f15148e3007a08d7d681e439%7Ceb14b04624c445198f26b89c2159828c%7C0%7C0%7C637213726093389193&sdata=U7bkUX6A9EnzJokrApXET9nRZ%2BwtXWEqfYQ9SUTsDlw%3D&reserved=0>

 Please let me know if you have any questions.

Thank you,

Kim

Kim Hankins

CPPO, CPPB SENIOR ACCOUNT EXECUTIVE,

NORTHWESTERN REGION

503.999.5013

[cid:2d0fc018-11b9-4663-9751-2a4064093fd7]

Connect With Us

https://linktr.ee/MMCAPInfuse

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