[Mmcap_list] FW: MMCAP Infuse COVID-19 Tests - FDA Waiver

[DOKE Lori * DAS]

Information Provided by MMCAP o previous email sent;

Here is the waiver by the FDA, information/links from the FDA…..

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%7C5fab1d2e46df43f3584d08d7d6837628%7Ceb14b04624c445198f26b89c2159828c%7C0%7C0%7C637213732417612033&sdata=zFckHqrEH8R3HPhvp66GVTYcXv9LqUxUa2irl%2FKRxhk%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%7C5fab1d2e46df43f3584d08d7d6837628%7Ceb14b04624c445198f26b89c2159828c%7C0%7C0%7C637213732417612033&sdata=6%2BmW4zgOiRWRsLXfe2ngA0LEYzWuL56N95XhIfM%2F1xI%3D&reserved=0>
Wednesday, April 1, 2020

To: MMCAP Infuse State Contacts, Advisory Board, Staff, Sr. Account Executives
Re: MMCAP Infuse COVID-19 Tests

Good afternoon,

MMCAP Infuse has executed contract amendments with two of our medical supply distributors to offer COVID-19 testing kits to members.

Contract # MMS18008 with Concordance Healthcare Solutions LLC has been amended to include:

·       Accutest Coronavirus (2019-nCoV) IgM & IgC Test from Jant Pharmacal Corporation – item number ID29000)

Contract # MMS18016 with Henry Schein Medical has been amended to include:

·       Standard Q-Covid-19 IgM/IgG Duo Test (20 Tests) – item number 1397701

As a reminder, contract # MMS14028 with Premier Biotech was previously amended to offer COVID-19 testing kits.

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.

Please let us know if you have any questions and thank you for choosing MMCAP Infuse.




Jared Huizenga
BS, Mass Communication
COMMUNICATIONS COORDINATOR
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651.201.3109

Connect With Us
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