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Stock will test it’s high volume low at 79 this year.
SALT LAKE CITY, March 25, 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 today announced that in response to the demand for high volume test availability for the SARS-CoV-2 (COVID-19) global pandemic, Predictive Laboratories, a wholly-owned subsidiary of The Company has notified the U.S. Food and Drug Administration of its intent to immediately distribute the validated Assurance AB™ COVID-19 IgM/IgG Rapid Antibody Test (Assurance AB) test to laboratories and healthcare workers at the point-of-care in the U.S.
The Assurance AB test was developed to detect the presence of IgM and/or IgG antibodies to the SARS-CoV-2 virus. The test requires only a fingerstick to sample an individual’s blood which is then placed on the self-contained test device. The test takes 15-minutes to display results. The test results indicate the presence of antibodies associated with the SARS-CoV-2 virus.
“Our company is committed to help with the global challenge of testing for the COVID-19 virus,” said Bradley Robinson, CEO of Predictive Technology Group. “Testing strategies for the pandemic are fluid and changing daily. We have worked diligently with our partners who have experience in testing tens of millions of patients worldwide. We appreciate their assistance in allocating resources and transferring vital knowledge for identifying individuals that have had an immune reaction and developed antibodies in response to virus exposure. Domestic and international governmental agencies, healthcare groups, pharmacies and employers have shown a strong interest in our test,” added Robinson. The Company will distribute the Assurance AB test through its wholly-owned subsidiary Predictive Laboratories, Inc., a CLIA certified and CAP accredited laboratory.
John Nelson M.D., former president of the American Medical Association and Predictive scientific advisory board member, commented, “The overwhelming need for a quick and accurate test for this pandemic is obvious. Focusing on an antibody test helps accelerate results and protect healthcare workers. The Assurance AB test is a valuable tool for truly understanding the spread of COVID-19 in the U.S.”
Assurance AB can help authorities, employers and healthcare workers make informed decisions on whether or not to continue precautions. Point of care serology testing may allow individuals with antibodies the confidence to go back to the workplace and engage in their communities.
Additional advantages of the Assurance AB test include:
inexpensive test with results in 15 minutes
antibody testing is less complex and remedies potential false negative results common in nasopharyngeal swab sampling
sample collection type (blood droplets) nearly eliminates the risk of spreading the virus to healthcare workers administering tests and/or to laboratory personnel who handle the submitted samples
Because of the rapid spread of the COVID-19 virus, several states including California and New York have recently expressed immediate need for rapid antibody testing. While there are benefits to viral testing, serology antibody testing allows patients to know if they have been exposed to the virus and if they have developed antibodies typically associated with immunity.
Assurance AB COVID-19 IgM/IgG Rapid Antibody Test is being manufactured in cooperation with Jiangsu Dablood Pharmaceutical CO, Ltd. Dablood Pharmaceutical has successfully distributed 38 million tests to date throughout Asia and Europe. To the best of Predictive’s knowledge, Dablood Pharmaceutical is one of very few companies approved by the Chinese government to co-develop and manufacture rapid antibody tests. Dablood Pharmaceutical is one of the largest diagnostic kit manufacturers in China and is currently producing up to 1.5 million units of the rapid antibody test per day in China. Predictive evaluated other potential developers and suppliers and believes Dablood Pharmaceutical provides not only existing inventory, its high-volume production capacity enables them to rapidly increase production to provide high-quality tests to meet rapidly expanding global demand. Dablood Pharmaceutical has been recognized by the Chinese government for its effort of developing and producing testing products to help the detect the COVID-19 and has received approval for distribution of its test across the domestic Chinese market and the European Union with a CE mark.
Predictive is also pursuing procurement authorization through the Biomedical Advance Research and Development Authority (BARDA) under the Office of the Assistant Secretary for Preparedness and Response (ASPR) in Health and Human Services (HHS). The Company cautions that if the federal government decides to restrict adequate reimbursement or the foreign import of products manufactured in Asia, the Company will not be able to provide access to these tests in the U.S.
About Predictive Technology Group, Inc.
Predictive Technology Group aims to revolutionize and personalize precision patient care. The Company’s 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. Predictive’s 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.
www.predictivelabs.com
Forward-Looking Statements:
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.
Contacts:
Predictive Laboratories
institutional@predictivelabs.com
commercial@predictivelabs.com
info@predictivelabs.com
855-497-3636
Investor Contact
Jeremy Feffer
LifeSci Advisors
jeremy@lifesciadvisors.com
212-915-2568
I received this email from my Predictive rep.
Just received this today.
Predictive Technology Group Announces Launch of Assurance AB™ COVID-19 IgM/IgG Rapid Antibody Test for Use by Laboratories and Healthcare Workers at the Point of Care
Assurance AB™ is a single-use, self-contained SARS-CoV-2 (COVID-19) antibody detection test that provides results in 15-minutes.
Will look into maybe using it. Finger prick blood sample.
Nothing new on the regenerative medicine side of products coming out. Reps are very quiet. One of my old reps heard thru their grapevine the company may be getting rid of Corecyte one of their mainstream products. No confirmation as of yet.
The stock price, would say otherwise.
There are many companies out there to order from. If you think PB is the only player you’re mistaken.
They just lowered prices on product and on bulk requirements which is a good thing for ordering docs.
One of my old Predictive sales reps came by my office yesterday. They stated that many sales reps have left the company on the regenerative medicine side and it is unlikely the company is going to survive. Take it for what it’s worth. Good luck.
Yes, what progress?
You have to have a stop in any stock you buy. Short trade, long trade whatever. I took my stop a few weeks ago for a small loss. Right now as a buyer of their Wharton’s jelly Regen products I’m concerned. Reason being we all prepay for our orders before shipment, with an average order going 20k. The worry now is I pay 20k today and never get my order because the company is belly up the next day. This could start to be a growing concern, shifting ordering habits to other companies. Just saying.
Yes, if they can get their IND completed using Corecyte for osteoarthritis of the knees it would go a long way for the company. Think fda approval, insurance, Medicare reimbursement etc.
Yes, and like I posted earlier my rep for PB stated ‘sales are coming back’ since the year end sale for product began. Coming back indicates, they had dropped, which I knew they had within my small circle of colleagues this year. Like I said I don’t have a dog in this fight as I sold my small position staying within my trading discipline. I still however use PB product but also use other companies as a supplier.
The fda is starting to send letters to all perinatal tissue processors that if they claim cells in their products they are going to be reclassified as a 351 product, meaning it’s a drug. Changing a product to a drug classification is a whole new set of headwinds for these companies. As long as they do not state there are cells in the product and do not make medical claims they will remain a 361. This came from one of my reps today.
Not that it helps any of you in the tank with this company now, but my rep told me sales are picking back up with the year end special pricing. New videos and other good things said to be coming in January. I do not have a dog in this fight, no longer hold any stock, but do use their products along with other company regenerative products.
You have that right. I'd guess lobbying from powerful players in the medical industry swayed Google.
Right. But most offices offering stem cell therapy advertise or your competition cleans your clock. Social media, FB, google, radio, TV.
Marketing a stem cell clinic has become more difficult versus a year ago. Google now disallows any ads with the term stem cell in the ad. If it’s in the ad you’re disapproved. We can’t even use the term regenerative medicine in the ad. You get flagged and they even block your non stem cell ads. They’re playing hardball. It’s not worth it. This has made it more difficult for offices to attract new patients. Fewer new patients for stem cell/Regen medicine procedures translates to offices ordering less cc’s per month.
There have been no new videos since the last one released. Call PB and ask them.
Yes I understand that, but.....they are trying to get back buyers they lost. For example I have a colleague who does 4 mil per year in this specialty stop ordering from PB going to a better priced competitor. They’re trying to win those clinics back as part of the strategy.
I think it’s going to test that .785 low, when who knows.
Pred has offered all clinics third tier pricing on all products thru the end of December. This will allow offices to load up and stockpile product at a lower cost going into 2020 and should boost year end earnings for the company.
You’re welcome, and for the record I am long at a low price and have no intention of selling at this point.
Snow, part of it is price. Predictive has a tier price structure for the cell based products like other companies. If I place an order for 10k worth of product I pay more per cc versus buying 15k or greater than 20k. Some companies don’t do this. If I want to use 5 ccs of product for a patient my price for an exosome product could be 2250. Same amount of product from PB can cost me double that. Many of us heard about the claim of changing of the characterization report well before the HB piece which turned a lot of docs off to the product, not all but many in my circle. Some providers are just using bone marrow MSC derived exosomes which Predictive does not offer at this point. The point is there are several reasons in this ever changing area of regenerative medicine.
There are plenty of other companies selling product so the field is competitive. As an example some providers are switching to using pure exosome products which PB does not offer. For others they feel the product they are using is superior to PB, such as Signature Biologics, Direct Biologics, Kimera, etc. Pricing is an issue and some companies don’t penalize clinics if they buy less versus buying more. I know in my small group of providers pricing is an issue. Another issue is some of the points raised in the Hindenburg hit piece especially the information claiming changing the characterization report of the product.
I’m busy enough to take every Friday off. Good day.
I can tell you this in my small world of clinicians about 3/4 have stopped using Predictive’s human cell tissue in favor of other companies. One was buying at least 100k per month in product. Another still buys that much. I use their product but not exclusively.
Live and learn, but don't repeat mistakes.
A good rule of thumb I learned from an old timer many years ago, if you’re fortunate enough to have doubled your money take your principle off the table and let your profit ride. This way your playing with the markets money. Just a thought.
New videos will come out in four weeks. Topics to include donor eligibility, testing, quality control, standards, and consistency of tissue. Possibly others.
Not sure what topics the upcoming videos next month will cover. Stay tuned.
More videos next month. Possibly up to seven more.
A colleague of mine orders $100k per month of product from PB. Most of us, in my circle, are below what he orders. The key for further demand down the line is the FDA. PB has set their regenerative business up properly to play within the guidelines the FDA has put out. Some other players have had their backside whooped on by the FDA and shut down.
FDA registered labs, not approved. There is a difference. Only drugs, are approved.
No that was just a preview. Video is supposed to be released later this week or early next to the public in a coordinated launch across multiple platforms
Yes, the pw was set to expire this afternoon. Will update
More coming next month, about seven or so. The password on the link expires this afternoon
You’re welcome. I received the okay to share around 2 pm, but was busy seeing patients so got around to sharing when I got home at 6 pm.
Video link. Use starwars as pw.
https://vimeo.com/367355547
Extrapolate: IOWs those papers cannot be used to market Predictive’s regenerative products. Or any other companies products. For example, ‘Mrs. Smith, this paper right here indicates mesenchymal stem cells can help Alzheimer disease. Your husband has Alzheimer disease so let’s give him Corecyte which has some mesenchymal stem cells in it, to help your husband’s Alzheimer’s”. We a’int there yet.