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100% on all points! I am still watching and this COULD be a great ticker IF they get CLIA waiver and start selling lots of tests
It is too easy to fall down a rabbit hole trying to research the FDA for information when all we need is for AXIM Management to tell us in clear language what the status is for CLIA Waiver Applications/Submissions/Approvals.
When I dig down into these Substantially Equivalent comparisons I come away with more questions than answers.
AXIM has in fact modified these tests from the originals. The modifications have been beneficial. Faster more accurate results. Added a reader. Fewer tears.
Obviously AXIM and Verséa Ophthalmics can sell these tests as per the original FDA 510K.
The best policy with AXIM is to not assume anything. If AXIM management did not tell you something then it didn't happen. When I opened my eyes and stopped assuming things about AXIM it was much easier to make decisions.
In my opinion the CLIA Waiver Application process had to start over in December with the announcement of Auer Precision as manufacturing partner.
In my opinion if AXIM did not tell you that CLIA Waiver Applications have been submitted to the FDA then they probably have not been submitted. Don't assume anything unless AXIM told you. In a press release or in a 10-Q or some other form.
Verséa Ophthalmics is signing up paying customers as CLIA compliant labs. That is all we know right now.
Good luck.
Not investment advice.
I believe that even though the Lactoferrin test appears to have been updated as a Class 1 test, possibly on December 22nd, 2023, it seems that AXIM still has the requirement to go through the CoW process (Certificate of Waiver).
Cut/Pasted from the FDA CLIA Waiver Application website.
https://www.fda.gov/medical-devices/ivd-regulatory-assistance/clia-waiver-application
A manufacturer of a test initially categorized as moderate complexity may request categorization of the test as waived through a CLIA Waiver by Application (CW) submission to the FDA. When a test is categorized as waived, it allows that test to be performed by laboratories with a Certificate of Waiver (CoW) or a Certificate for Provider Performed Microscopy (PPM) in addition to the other CLIA Certificate types. In a CW submission, the manufacturer provides evidence to the FDA that a test meets the CLIA statutory criteria for waiver, 42 U.S.C. § 263a(d)(3). The statute states that:
"The examinations and procedures [that may be performed by a laboratory with a Certificate of Waiver] are laboratory examinations and procedures that have been approved by the Food and Drug Administration for home use or that, as determined by the Secretary, are simple laboratory examinations and procedures that have an insignificant risk of an erroneous result, including those that — (A) employ methodologies that are so simple and accurate as to render the likelihood of erroneous results by the user negligible, or (B) the Secretary has determined pose no unreasonable risk of harm to the patient if performed incorrectly."
If the Lactoferrin test is a Class 1 test then by definition the Lactoferrin test is a CLIA Waived test. Why has AXIM Management not told us this???
Is there any benefit in having one Class 1 test and the other a Class 2 test?
There should be great benefit.
First and foremost ALL of our potential customers should be able to order the Lactoferrin Tests and become familiar with the test reader. Then already be familiar with the TPOC system once the IgE test is Waived.
NOTE: I believe the IgE test is currently stuck inside an FDA division where ALL tests are classified as Class 2. That could be a problem except our test is a Tear-based Point-of-Care test.
510(k) Number K934473
Device Name
LACTOFERRIN MICROASSAY SYSTEM
Date Received 09/14/1993
Decision Date 12/03/1993
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K934473
===============================
510(k) Number. K991316
Device Name
TOUCH TEAR IGE MICROASSAY KIT
Date Received 04/19/1999
Decision Date 08/09/1999
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K991316
===============================
Our IgE test is "Substantially Equivalent (SESE) to other IgE tests that fall under the Class 2 designation. Some IgE diagnostic devices test blood samples. Our device tests tear drops.
It appears all IgE tests fall under the.
Division of Immunology and Hematology Devices (DIHD) and seems all are coded as Class 2.
There is an Ophthalmics division under DIHD.
TPLC - Total Product Life Cycle
Device : Ige, Antigen, Antiserum, Control
Product Code DGC
Regulation Number 866.5510
Device Class 2
Substantially Equivalent (SESE)
HOWEVER. I believe our Lactoferrin test has already been updated as a Class-1 (Waived) test as of December 22, 2023. If I am reading correctly.
Our Lactoferrin test may be a Class 1 test since December 22nd, 2023. (Class 1 = Waived)
Replying to a previous post where I provided links to FDA database for our 510K tests.
Pages to both tests show they were updated December 22nd, 2023.
The link to the Lactoferrin Test seems to indicate a Class 1 test.
Click on the Lactoferrin link.
Click on the link to section Sec. 866.5570
Lactoferrin immunological test system.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.
The IgE test still appears to be a Class 2 test, but that page was last updated on 03-11-2024.
Searching on new information for IgE now.
510(k) Number K934473
Device Name
LACTOFERRIN MICROASSAY SYSTEM
Date Received 09/14/1993
Decision Date 12/03/1993
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K934473
===============================
510(k) Number. K991316
Device Name
TOUCH TEAR IGE MICROASSAY KIT
Date Received 04/19/1999
Decision Date 08/09/1999
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K991316
===============================
Applicant
TOUCH SCIENTIFIC, INC.
3209 GRESHAM LAKE RD.
SUITE 112
RALEIGH, NC 27615
FDA CLIA waiver guidelines. Review takes anywhere from 90 days to 320 days.. There is a FastTrack path for 510K/CLIA-WAIVER applications submitted together. 180 days.
Enjoy
https://www.fda.gov/medical-devices/ivd-regulatory-assistance/clia-waiver-application
Additionally Auer Precision is ISO-13485 certified.
Cut/Paste from link on page that opens a pdf:
"Administrative Procedures for CLIA Categorization - Guidance for Industry and Food and Drug Administration Staff "(PDF - 124KB)
A test initially categorized as moderately complex might meet the statutory criteria for CLIA
waiver if the device is simple to use and the sponsor demonstrates in studies conducted at the
intended use sites that the test is accurate and poses an insignificant risk of erroneous results. If a
Sponsor of a test categorized as moderate complexity believes their test meets the statutory
criteria for CLIA waiver, they may submit a CLIA Waiver by Application to request
categorization of the test system as waived. Such a submission should be mailed to the CDRH
Document Control Center (DCC) at the address listed above and identified as a CLIA Waiver by
Application submission. Note that all such submissions should be directed to CDRH, regardless
of the FDA Center responsible for the marketing review. To expedite review, FDA strongly
encourages submission of a validated eCopy per the Guidance Document “eCopy Program for
Medical Device Submissions.”
(http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocu
ments/UCM313794.pdf ).
CLIA Waivers by Application should reference a cleared/approved marketing application (e.g.,
510(k), PMA, BLA). As described in the MDUFA III and MDUFA IV Commitment Letters, an
applicant should inform FDA that it plans to submit a Dual 510(k) and CLIA Waiver application
Lol. Right!!! My guess is the clock was restarted AFTER the December 20th announcement about Auer Precision becomming the Merchandising partner for AXIM.
Besides Dr Sambursky has done this before. Once all the ducks got lined up on December 20th my guess is the paperwork was submitted after that. Maybe in January.
I don't think anyone benefits with an extended delay. Not AXIM. Not Verséa. Not Shareholders.
The FDA website is very busy with activity. This should not take long once the paperwork is complete.
CLIA Waiver is taking longer than a Spaceship to Mars. Trial that takes 3 weeks to do. Either the FDA or AXIM has a problem. AXIM has no reason for the delay unless they left out some important facts in their story. We know John would never do that. LoL
I think now is a great time to buy.
On the other hand.
Unless we hear about CLIA Waiver approvals or some type of unexpected merger with Verséa or something else as big News as that, it looks like it takes awhile for AXIM to become cash-flow positive.
We have to start picking up more than one customer per week at some point.
It seems like Jessica Barr is the lonely road warrior for Verséa Ophthalmics. Obvoiusly she must be flying back and forth across the United States instead of being a road warrior but I digress.
Even AFTER CLIA Waiver approvals Verséa Ophthalmics has to ramp up their sales staff to ensure every location is trained correctly.
I do expect the growth story to become a really big deal at some point. But it feels like retail investors are still pushing this band wagon for months into the future.
Not investment advice.
Don't invest money needed for food or rent.
Have a great day!!!
First customer from the Pacific Northwest announced today on LinkedIn.
https://www.linkedin.com/posts/vers%C3%A9a-ophthalmics_welcome-pacific-clear-vision-institute-to-activity-7173764956067115009-3gn7?utm_source=share&utm_medium=member_android
Hashtags related to our company and partners.
#VerséaOphthalmics
#VerséaHealth
#TPOC Tear based Point-of-Care
#DryEye #Diagnostics #Quantitative
#Lactoferrin #TotalIgE
#TPOCTITAN #TPOCTITANS
#AuerPrecision ISO Certified
#ISO9001 #ISO13485
#AXIMBIOTECH
#AXIMEYE #DryEye
#Lactoferrin
#TotalIgE
Just like the last dip. Always a big purchase transaction. 3M share day today so far. I have trouble understanding it but when you read people who follow it closely like Tex's posts it seems like some people are worried.
Someone is crazier than me 1.414,300 Buy order
Call me Crazy Bought another 78000
Sure would have been!
I see 50,000 at 0.0143.
Guess that was Dean's.
.0431 would have been a nice bump on the chart
I've seen this before which is why I follow two different platforms for trades. On the E*TRADE platform. You're right it does show it as a sale (red)but when we check trades here on this platform, it shows it as a buy and it's in green. I'm just guessing but since it came in at a lower price, than your first trade and it shows up red it was the company raising money? Be happy for the lower price. :)
Purchased 70,000 shares today. First part 50,000 filled @ .0431 second part 20,000 filled @ .014105 and shows as a sale. Hmm
Not good for charts when they do that crap.
The share volume has picked up a lot over the last month. A substantial increase in volume seems like it could be a good sign.
True!
I was also hoping for 2 customer announcements this week from Verséa Ophthalmics. Guess I'm greedy or impatient.
I'm not complaining and I'm definitely happy with the progress shown over the past 2.5 months.
HOWEVER
If we only get 1 announcement per week it will take 120 weeks for AXIM to become cash-flow positive - UNLESS we receive CLIA waivers from the FDA sometime before then.
Not investment advice.
Don't invest money needed for food or rent.
Have a good weekend.
CLIA waiver could be months or years away...we wouldn't know because AXIM isn't giving CLIA updates.
OMNI EYE CENTER - LASERVISION from Edmond, Oklahoma is a second generation practice that has been in business for more than 30 years. 4 doctors on staff.
Not many more details to share.
I think a previous post i shared said over 48,000 eye care locations in US. AXIM needs only about 120 locations to become cash-flow positive. Once CLIA Waiver approvals are received this little company can grow sales and revenue very quickly.
New Customer from Edmond Oklahoma.
I will look at the details this evening.
Have a good day.
https://www.linkedin.com/posts/vers%C3%A9a-ophthalmics_tpoctitan-tpoc-ded-activity-7170765029711958016-CaBo?utm_source=share&utm_medium=member_android
Links related to our company and partners.
#VerséaOphthalmics
#VerséaHealth
#TPOC Tear based Point-of-Care
#DryEye #Diagnostics #Quantitative
#Lactoferrin #TotalIgE
#TPOCTITAN #TPOCTITANS
#AuerPrecision ISO Certified
#ISO9001 #ISO13485
#AXIMBIOTECH
#AXIMEYE #DryEye
#Lactoferrin
#TotalIgE
I still anticipate a block of Form 4's to come out when the time is right and it does seem very near.
Checked for the 10K A today and realized that its due at the end of March then a 10 day extension is possible until April 10. I had an accelerated filer in mind when I posted that it was due today. No matter, something is happening with the increasing interest in the stock.
Appreciate your thoughts as usual Tex. I have been wondering about the NPTX ticker being used for Versea not a direct combination with AXIM. Of course all three of the companies would own shares of the other entities and have an even increased note note relationship. I do not see AXIM as part of a direct combination with the possible exception of Neuropathix although that puzzle piece seems to fit MJNA better.
Its been a while since I researched the birth of Versea but one part that I recall is that the same crew started a related company previously and ramped it up into a successful acquisition. They have a history of operating that way. The evolving enterprise and some of their PR seems to suggest that they are on a track to go public.
I do think it would be difficult for AXIM to merge with Verséa Health. AXIM would probably want it to be a 50-50 merger. Verséa Health would probably want a bigger chunk than 50%.
On the other hand the AXIM patents and cancer research might be the glue that could make a 50-50 merger at least attractive.
It is fun to speculate when we have a slow news week. Actually the big picture the past 2 months has produced a ton of big news items.
Auer Precision agreement
Weekly customer announcements
Additional order of reader machines.
I do think Catalina Valencia has been contributing a lot behind the scenes the last few years. However my guess is the leadership after Mr Huemoeller will be someone younger.
Maybe from that angle a merger with Verséa Ophthalmics would work in the best interest of everyone. Verséa has some younger leaders that could step in and help build out a stronger portfolio of products. Everyone wins.
I agree with you about Verséa going public. It seems like that's what Biotech companies do. Build some products and sell to the big players.
I'm not sure if AXIM and Verséa could combine companies where everyone would be happy with their share. But the 2 companies might be stronger together.
I don't know anything about NPTX.
The Tarsus name came up from the reactions to LinkedIn posts.
With regard to the trading Tex the volume after both of the dips in February was quite dramatic. Almost as if insiders had submitted note conversion requests to the company and could finally buy without impacting the plan. Its also possible that there was shorting activity involved in those dips that needed to be covered. You gotta love Catalina. Knowing that all of this was coming she was willing to purchase her 10M shares at 3 cents after she scored the DED relationship with her old cronies. She was willing to fund the company at that level in exchange for being able to purchase such a large block of shares off market. Either way she is a big believer. Cat was willing to put down serious change while her peers paid peanuts for options and signed free deals to be the recipients of put options. Maybe that was her buy in price to become a family member. I see her running this show a few years down the road after the company is solidly launched and the old family members have made their money.
Now that is an interesting and speculative take on things Tex. As you have read, I have been thinking that perhaps AXIM helps Versea go public, possibly using the family NPTX ticker and Neuropathix becomes part of AXIM or MJNA Something has to happen to it because I doubt that the Cross family, Dean P or MJNA would benefit from it remaining in its current condition long term. Weighing in your comments I am still quite certain that based on the history of the Versea principals they are quite likely to go public soon with or without the optics business. I am predicting that they will retain it but everything has its price. When I used to work in marketing I used to say that everything that is not screwed down to the building is for sale for the right price and if you really wanted it the building was for sale too.
Tarsus Pharmaceuticals (TARS) also in the EyeCare space just raised $100 Million. Their current revenue of $17.5 million seems pretty low to justify such a rich share price. Doesn't seem to add up.
Could the AXIM + Verséa team follow the same path as Tarsus? Surely Verséa Health would not sell their Ophthalmics division right here at the beginning of a growth story would they? Merger of Equals? Could Verséa need cash? I don't know.
It seems like builders would want to sell a product after it is finished, like a house. The Verséa Ophthalmics + AXIM foundation is not even dry yet. The house still needs to be built. Catalina Valencia didn't buy millions of shares of AXIM to sell away for a loss did she?
It just seems like the more LinkedIn posts shared by Verséa Ophthalmics the more people at larger companies in the eyecare space have a reaction to those posts. Including people from Tarsus and Novartis and Bausch and Lomb among others.
3.6 million shares yesterday. That's only about $55,000 on the buy side and the sell side but it was an interesting looking day.
Lots of round numbers throughput the day. 2.5 million shares in one 10 minute time slot in the morning. But then another million shares broken down into large round chunks.
Maybe the story is starting to get out there? I wonder if a doctor or 2 or 10 bought some shares yesterday?
Right now as far as the share price, I will gladly take "interesting" over nothing. On the business side we are watching a growth story in slow motion. At some point we may wish we would have bought more cheap shares when they were available.
Good luck to all.
Not investment advice.
I appreciate your trust. All of your posts since 2012 have been to ask me questions! I think that both companies will do as well. Three years ago I thought that by now they would be doing very well. Good things come to those who wait.
Blue Skys, Where do you see AXIM and MJNA going in the coming months and years?
It will be interesting to see of it is AXIM or the need to drive the sister stocks that finally turns this around. Marijuana rescheduling or descheduling could create a business cast to increase the valuation of the massive AXIM ownership of MJNA when that stock is fundamental driven. I just wish I understood the game plan for the company formerly trading as NPTX. I am still guessing that ticker will have a higher purpose in the grand scheme.
JH is really an expert in controlling the stock price. He continues to amaze me with his finesse in getting the best note conversion and sucking the value out of MJNA all at the same time. I expect that some day he will show case that talent in a more desirable direction. It has taken him years to knock it down this low.
I just noticed that Verséa Ophthalmics team member Rahim Hirji is also managing Clinical Training and Implementations. Jessica Barr has Director in her title. Rahim is a VP.
Point being, multiple people help with new Implementations even though Jessica Barr is the one who puts her signature on the final approval.
SCIENTIST ALIM SEIT-NEBI
˜======================
BTW, when it is a slow news day I like to use LinkedIn to see what AXIM scientist Alim Seit-Nebi is posting on LinkedIn. And/Or what posts he likes or comments on. Alim has not posted for some time, but here are a few posts from other people he has found interesting in the past week. All related to cancer research.
I only share these because i believe the cancer research angle still exists at AXIM. Maybe in the future we will hear of cancer tests from tear drops??? I don't know, but maybe Alim knows.
BTW, IHUB gets confused on these links to LinkedIn. You might need to exit IHUB after looking at each link so you can view the next link.
https://www.linkedin.com/posts/megan-conlon-phd-91369889_new-immune-cell-engagers-for-cancer-immunotherapy-activity-7167955333150179328-auk3?utm_source=share&utm_medium=member_android
https://www.linkedin.com/posts/science-magazine_scienceperspective-activity-7167888577450754048-gSIG?utm_source=share&utm_medium=member_android
https://www.linkedin.com/posts/joseph-steward_spatial-analysis-reveals-combinative-role-activity-7166794645203599360-kp6r?utm_source=share&utm_medium=member_android
I suppose AXIM is just a hobby until the share price agrees with what appears to be a growth story that very few know about.
My posts are not meant as investment advice, but they are based on my own research. In my opinion don't invest money needed for food or rent or even the pursuit of happiness. Maybe when expectations fall away, AXIM will surprise a few people.
Until then, have a blessed day.
Thank you for all your hard work posting this great info. Watching this one.
Thank you for all your hard work posting this great info. Watching this one.
What I noticed about today's announcement by Verséa Ophthalmics on LinkedIn.
There must be a very rapid consolidation happening in the eyecare space. EyeSouth Partners did not make the list of the 2023 Top Fifty largest Eyecare Networks report from June 2023. However looking at the details shared in the following announcement from December 19th 2023 EyeSouth Partners would have been almost right in the middle of the Top 50 largest Eyecare networks with 180 locations.
Consolidation should be very good for AXIMs and Verséa Ophthalmics roll-out plans.
HIGH LEVEL SUMMARY:
EyeSouth’s affiliate network consists of 39 practices with over 300 doctors providing medical and surgical eye care services at more than 180 locations including 20 surgery centers throughout Georgia, Texas, Louisiana, Florida, Tennessee, Ohio, Kentucky, Pennsylvania, Alabama, Illinois, North Carolina, and South Carolina.
LINK TO ARTICLE:
EyeSouth Partners Affiliates With Atlantic Eye Institute, Representing The Network’s 39th Affiliation and Ninth in Florida - https://www.eyesouthpartners.com/news/eyesouth-partners-affiliates-with-atlantic-eye-institute-representing-the-networks-39th-affiliation-and-ninth-in-florida/
Not investment advice.
Have a good day.
Another customer announced this morning
https://www.linkedin.com/posts/vers%C3%A9a-ophthalmics_tpoctitan-tpoc-ded-activity-7168228316540317696-VXJS?utm_source=share&utm_medium=member_android
Have a good day.
25,000 device installations worldwide.
Ophthalmology Breaking News.
Maybe not an "Apples to Apples" comparison to AXIM. However AXIM/Verséa are selling to the same offices as Optos.
I paid $30 to have pictures taken of my retinas last time I had my eyes checked.
Advantages:
*** No pupil dilation
*** better image capture.
*** Doctor keeps image for future reference
Win-Win.
25,000 global device installations.
The AXIM/Verséa Ophthalmics test-reader device is not a 1-trick pony. Two existing FDA cleared 510K tests. MMP-9 510K announced as available in 15 months. Maybe other tests to follow.
https://ophthalmologybreakingnews.com/optos-celebrates-device-installations-worldwide-clinical-studies
Optos's unique position in the market is highlighted by its proprietary single-capture, 200-degree, ultra-widefield retinal imaging technology. This technology is pivotal for diagnosing and managing a broad spectrum of ocular conditions, enhancing the detection and diagnosis processes.
150 tests per month is only 75 customers per month
75 customers × 2 tests =150 tests per month.
15 to 20 office days per month allows for a 4 or 5 working days per week.
5 clients per day with 15 working days per month.
4 clients per day with 20 working days per month.
These numbers are probably on target for smaller offices, but might be conservative estimates for offices with multiple doctors or offices within a larger network of eye surgery clinics.
"AXIM expects clinics to perform approximately 150 tests per month."
I noticed two things from the announcement last week.
"Most clinics require at least two readers to efficiently perform both tests."
This is new information and having 2 readers allows both tests to be administered at the same time. Potentially increasing the number of tests used per day.
"AXIM expects clinics to perform approximately 150 tests per month."
For some reason I thought the original number was 300 tests per month. If the new number is 150 tests per month then Verséa needs to sign up 120 doctor offices for AXIM to become cash-flow positive instead of just 60 locations. Inflation on labor may push this number higher, but let's stay with 120 locations for now.
150 × $10 × 0.70 × 120 = $126,000 per month.
150 tests per month
$10 AXIM receives per test
0.70 percent after manufacturing cost.**
120 locations
$126,000 per month before scientists get paid and rent and bills and other expenses are paid.
** Cost per manufacturing tests was originally projected to be 30% but we don't have any new information after Auer Precision was signed as contract manufacturer.
Verséa Ophthalmics has had a number of announcements of paying customers the last 2 minths. Two announcements mentioned 3 new locations each. Let's estimate 12 to 15 current locations are currently selling our tests.
We are still months away from being cashflow positive at this current pace.
CLIA Waiver approval is still the goal and is required before the current narrative changes much.
Good luck to all.
Not investment advice.
Since the AS increase was posted on Silver Flume during Q4, the derivative liability insufficient shares accounting paradigm must be resolved in the 2023 10K and the new OS must be revealed. With the 10 day extension we should know the new OS and note conversion details, if applicable, by Monday March 11, 2024. That will have been a long time coming. I can only guess that some of the recent selling is based on that in addition to the recent news (that I consider to be bullish) regarding the legal settlement for the DED testing technology. We will soon see how accurate our squirrel friend was with his prediction of an OS under 350M shares at launch. The last time we had a series of form 4's from insiders converting some of their variable convertible notes and I believe Blake Neil Schroeder converting all of his notes we had quite a rally in the stock price as it was taken as a management vote of confidence on the future of the company. I have crunched some numbers regarding what I think the OS will be but I am going to remain silent on that issue at least until that Monday nears. Depending on external factors the results could be released any time between now and then. So many pieces to assemble here. Possibly a one two punch with the Wavier issued just before or after the 10K.
Getting close to that .02! A little good news gave a bounce.
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Unlike currently available serological COVID-19 tests that detect an antibody response to the virus, AXIM’s rapid 10-minute test measures a specific subpopulation of antibodies to block binding of the virus to host cell receptors. While there are expensive, time consuming laboratory tests that measure neutralizing antibodies, NeuCovixTM differs in that it is a portable, low cost, rapid point-of-care test with results in 10 minutes.
“We are hopeful our test fills an important need in these uncertain times. While other tests merely show whether someone was infected with coronavirus, we took it a step further by creating a test that stratifies individuals into those who have neutralizing antibodies, which are essential in preventing reinfection, and those who don’t. The test can be deployed for point of care use in convalescent plasma transfusions to severely ill patients and for evaluating efficacy of upcoming vaccines in generating protective antibodies,” said Sergei Svarovsky, PhD, MBA, AXIM’s CSO and co-inventor of NeuCovixTM.
An immediate application of NeuCovixTM, a point-of-care test, is to measure levels of neutralizing antibodies in convalescent plasma so that plasma with the highest levels of neutralizing antibodies can be identified and administered to patients fighting COVID-19. Without this knowledge, many patients could be undertreated with non-neutralizing plasma and may not benefit from this treatment.
Another application of NeuCovixTM is to help ensure that vaccines elicit high levels of neutralizing antibodies. When a vaccine is available, manufacturers can employ the NeuCovixTM rapid, point-of-care test to evaluate protective immune responses in vaccine recipients.
AXIM® Biotech CEO John W. Huemoeller II commented, “Our goal was to make this test, accurate, fast and relatively inexpensive so it could serve as an ‘Immunity Passport port™’ for vaccine developers around the world as they begin larger Phase II and III clinical trials. We are optimistic that NeuCovixTM will be widely used, becoming the gold standard in assessing levels of immunity.”
Doug Lake, Ph.D. and co-inventor of NeuCovixTM commented, “Everybody who recovers from COVID-19 makes antibodies against the virus, but since all antibodies are not created equal, you really want to know if the antibodies you make neutralize the virus. People who recover want to make sure they are protected from re-infection and that they won’t infect others.”
AXIM also announced the filing of a pre-Emergency Use Authorization Application (EUA) and has already initiated dialogue with the FDA in order to finalize its EUA submission. The intellectual property relating to the novel serological test is the subject of Provisional Patent Application No. 63/023,646 “Convalescent Plasma Testing and Treatment” filed on May 12, 2020.
About AXIM® Biotechnologies
Founded in 2014, AXIM® Biotechnologies, Inc. (AXIM) is a vertically integrated oncology company developing rapid diagnostic tests for the early detection of cancer and proprietary small molecules drugs to treat cancer and block metastasis. The Company is also developing novel antibodies for therapeutic and diagnostic uses for oncological therapeutics. For more information, please visit www.AXIMBiotech.com.
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