Zomedica Corp (ZOM)

[Raffis]

READ CAREFULLY, GET OUT OF ZOM: Bulk Acoustic Wave is Research / Investigational USE ONLY.

“Zomedica Signs Exclusive Agreement with Qorvo Biotechnologies for Global Veterinary Rights to Diagnostic Point-of-Care Platform SENSOR-BASED TECHNOLOGY AIMS TO PROVIDE VETERINARIANS WITH COLLECTION OF RAPID REFERENCE-LAB QUALITY TESTS AT THE POINT-OF-CARE

ANN ARBOR, Mich., Nov. 27, 2018 (GLOBE NEWSWIRE) -- Zomedica Pharmaceuticals Corp. (NYSE American: ZOM) (TSX-V: ZOM), a veterinary diagnostic and pharmaceutical company, today announced it has entered into a development and supply agreement with Qorvo Biotechnologies, LLC (Qorvo), a wholly-owned subsidiary of Qorvo, Inc. (Nasdaq: QRVO) focused on bringing its piezo-electric Bulk Acoustic Wave (BAW) sensor to the veterinary health sector. Under the terms of this agreement, Zomedica has exclusive, global rights to develop and market Qorvo's investigational point-of-care diagnostic platform for veterinary use.
https://www.qorvo.com/newsroom/news/2018/zomedica-signs-exclusive-agreement-with-qorvo-biotechnologies-for-global-vet-rights-to-point-of-care....”


“I. Introduction
FDA is issuing this guidance document to provide the current thinking of the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) on when in vitro diagnostic (IVD) products1 are properly labeled “for research use only” (RUO) or “for investigational use only” (IUO)2. FDA is concerned that the distribution of unapproved and uncleared IVD products labeled RUO or IUO, but intended for purposes other than research or investigation (for example, for clinical diagnostic use3), has led, in some cases, to the clinical diagnostic use of products with unproven performance characteristics, and with manufacturing controls that are
1 “In vitro diagnostic products are those reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body. These products are devices as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act (the act), and may also be biological products subject to section 351 of the Public Health Service Act.” Title 21, Code of Federal Regulations (CFR), section 809.3(a).
2 This guidance is only intended to apply to IVD products that have not been approved, cleared or licensed for any use, and it is not intended to address off-label uses of any approved, cleared or licensed products.
3 Throughout this guidance document, references to “clinical diagnostic use” and “use in clinical diagnosis” include use in making medical treatment decisions.
4
Contains Non-binding Recommendations
inadequate to ensure consistent manufacturing of the finished product. Use of such tests for clinical diagnostic purposes may mislead healthcare providers and cause serious adverse health consequences to patients, who are not aware that they are being diagnosed with or treated based on the results of tests with research or investigational .....” https://www.fda.gov/media/87374/download