Company provides formal response to misleading recently published short report
SALT LAKE CITY, March 30, 2020 (GLOBE NEWSWIRE) -- Predictive Technology Group (OTC PINK: PRED) (Predictive or The Company), a leader in the development of genetic and molecular diagnostics and companion therapeutics, and its manufacturing partner, Jiangsu Dablood Pharmaceutical CO, Ltd. (Dablood), a partner entity of Da An Gene Co., Ltd., today made several updates and progress reports on its Assurance AB COVID-19 IgM/IgG Rapid Antibody Test (Assurance AB) intended for laboratories and healthcare workers at the point-of-care in the U.S.
An opinion piece critical of Predictive was posted online last week by individually unidentified author(s) who admitted they have taken a short position in shares of The Company, said John Sorrentino, chairman of Predictive Technology Group. We encourage every reader to do their own due diligence and review the documents posted today on Predictive Laboratories website. The author(s), hiding behind anonymity and attempts to disclaim also warn that Hindenburg Research makes no representation, express or implied, as to the accuracy, timeliness, or completeness of any such information. Because the opinion piece itself warns readers of its short position-based bias and its unwillingness to guarantee the accuracy of any information it espouses, The Company will not dignify the opinion piece with a point-by-point response, however we felt compelled to address a few egregious misrepresentations and untruths.
The opinion piece asserts a material falsehood that Dablood is NOT one of the companies approved by the Chinese government to offer COVID-19 tests. The official list of approved COVID-19 test providers is published by the Chinese government, was updated as of March 17th, and does not include Dablood or its affiliates. If properly investigated, one can find that #5 on the referenced list is Da An Gene Co., Ltd. Guangzhou Darui Biotechnology, a subsidiary of Da An Gene Co., Ltd., has joint venture entity in Dablood. As such, Dablood operates under the Da An Gene Co., Ltd. license.
Regarding Predictives formal request for Emergency Use Authorization (EUA) from the FDA to distribute Assurance AB, the opinion piece states, in part, that Predictive has no specific approval from requisite U.S. authorities to provide this test. The Company views this statement as simply not true.
The FDAs recent guidance on COVID-19 antibody (i.e. serological) diagnostic tests clearly allows manufacturers to market these tests in the United States to laboratories and healthcare workers at the point of care, so long as the tests have been validated and notification is provided to the FDA, said Bradley Robinson, CEO of Predictive Technology Group. The Predictive/Dablood test meets these criteria. Additionally, The Company has formally submitted an EUA with the FDA. If granted, this would provide Predictive the ability to market the test for in-home use.
Predictive Laboratories, Inc., a wholly-owned entity of The Company, operates a CLIA-certified and CAP-accredited laboratory which is responsible for the distribution of the Assurance AB. Predictive Laboratories has updated its website to include the following:
- Dablood Board of Directors response to the erroneous and misleading Hindenburg opinion piece published on March 27, 2020
- FDA confirmation receipt of EUA application
- Representative of Foreign Manufacturer Notice from Dablood to the FDA
- Manufacturer FDA EUA Notification from Dablood to the FDA
- U.S. Agent Retainer Agreement
The Hindenburg piece repeatedly and inaccurately attempts to cast Predictive solely as a stem cell company while ignoring The Companys other diagnostic assets, such as ARTguideTM and FertilityDXTM, and its recently announced diagnostic assay collaboration with Atrin Pharmaceuticals. In this context, a COVID-19 rapid antibody test is a logical addition to Predictives portfolio. Nevertheless, they attempt to cast Predictive as simply a stem cell company, said Robinson. Predictive encourages thoughtful investors to consider the motives of these anonymous authors when assessing the truthfulness and accuracy of any statement or report in the opinion piece. Predictive will pursue any and all legal actions against individuals and entities who intentionally mislead Predictive stakeholders.
The response to the announcement of Assurance AB (March 25, 2020) has been very strong, continued Robinson. In particular, both international and domestic governmental agencies have expressed strong interest in how rapid antibody testing can help with the public health response to this critical pandemic. We want to acknowledge the tireless activities by our employees and partners in developing a tool that can be a part of solving this global health crisis.
About Predictive Technology Group, Inc.
Predictive Technology Group aims to revolutionize and personalize precision patient care. The Companys entities harness predictive gene-based analytics to develop genetic and molecular diagnostic tests, as well as companion therapeutics, in order to support a patient from diagnosis through treatment. The Companies tests and products empower clinicians to provide their patients with the highest level of care. Predictives subsidiaries include Predictive Laboratories, Predictive Biotech and Predictive Therapeutics. For more information, visit www.predtechgroup.com.
About Predictive Laboratories, Inc.
Predictive Laboratories a wholly owned molecular and genetic diagnostics company of Predictive Technology Group (OTC Pink: PRED) is focused on hard-to-detect diseases. The laboratory is equipped with state-of-the-art equipment for any next-generation sequencing experiments including whole exome sequencing, gene and genetic marker panels, and low-pass whole genome analysis of embryos for aneuploidies.
To the extent any statements made in this release contain information that is not historical, these statements are essentially forward-looking and are subject to risks and uncertainties, including the difficulty of predicting FDA approvals, acceptance and demand for human cell and tissue products and other pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, availability of raw materials, availability of additional intellectual property rights, availability of future financing sources, the regulatory environment, and other risks the Company may identify from time to time in the future. These forward-looking statements are based on the current plans and expectations of management and are subject to a number of uncertainties and risks that could significantly affect the company's current plans and expectations, as well as future results of operations and financial condition. A more extensive listing of risks and factors that may affect the company's business prospects and cause actual results to differ materially from those described in the forward-looking statements can be found in the reports and other documents filed by the company with the Securities and Exchange Commission. The company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.