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See 5th Row of Page 6:
https://www.who.int/diagnostics_laboratory/200402_imdrf_collated_table_2_april_2020.pdf?ua=1
https://www.who.int/diagnostics_laboratory/200402_imdrf_collated_table_2_april_2020.pdf?ua=1
THE Singapore Exchange (SGX) has queried Catalist-listed Biolidics over its appointment of a scandal-hit company as an exclusive distributor for rapid Covid-19 antibody test kits.
But the board replied in a filing on Sunday night that it does not expect a material impact on its business plans from its agreement with Nasdaq-listed Aytu Bioscience.
&ldquo The company will continue to monitor publicly available information on Aytu and will take appropriate steps to mitigate any potential negative financial impact on Biolidics arising from such developments,&rdquo it said, without going into details on what these steps are.
Biolidics, a cancer diagnostics firm, was asked how it came to pick Denver-based Aytu to distribute its rapid test kits for novel coronavirus antibodies last week.
The SGX also asked what the financial impact could be to Biolidics from ongoing probes into claims that Aytu supplied healthcare providers with coronavirus tests from unapproved Chinese manufacturers and may have breached United States securities laws.
Biolidics said that it was introduced to Aytu by a Denver-based business associate in end-March and was aware of media reporting on the alleged distribution of unauthorised test kits.
Still, it went ahead with its distributorship agreement on April 23 because it believed, after carrying out due diligence such as an assessment of Aytu&rsquo s financial standing and track record, that the company would be a suitable distributor for its own coronavirus test kits.
Biolidics said that it has not verified the claims or sought legal advice in the United States, but added law firms&rsquo probes of Aytu &ldquo may be considered &lsquo attorney advertising&rsquo &rdquo under US rules.
&ldquo While the company is not privy to the grounds of investigation of potential claims on behalf of purchasers of Aytu against Aytu, the company believes that it would not be impacted by news on such investigation,&rdquo said Biolidics.
It noted that it can appoint another distributor if a contractual minimum purchase quantity is not met, or immediately terminate the agreement if terms are breached by Aytu or sub-distributors.
Separately, the board told the Securities Investors Association (Singapore), or Sias, that an executive&rsquo s remark about commissioning some two million test kits in two months &ldquo was referring to the intended build-up in inventory in anticipation of orders for the test kits and not firm orders&rdquo .
&ldquo As such, the company would like to clarify that the statement should not be interpreted as a projection by management,&rdquo Biolidics added.
&ldquo The decision on the order volume by the company in the next two months will be dependent on the sales volume as well as availability of capital and human resources.&rdquo
To another question from Sias, on how Biolidics adds value to test kits that are made by a Chinese supplier in Nanjing, the company said that &ldquo such information is commercially sensitive&rdquo .
&ldquo The disclosure of such information may negatively impact the competitive strength of the company,&rdquo it asserted, while clarifying that the test kits do not make use of Biolidics&rsquo patented technology to extract tumour cells from small amounts of blood.
Biolidics reiterated to shareholders that it &ldquo is actively developing the market for the test kits&rdquo in Singapore, the Philippines, the European Union and the US, and seeking regulatory approval elsewhere, although it also specified that it has not submitted any application to Indonesia.
But the board replied in a filing on Sunday night that it does not expect a material impact on its business plans from its agreement with Nasdaq-listed Aytu Bioscience.
&ldquo The company will continue to monitor publicly available information on Aytu and will take appropriate steps to mitigate any potential negative financial impact on Biolidics arising from such developments,&rdquo it said, without going into details on what these steps are.
Biolidics, a cancer diagnostics firm, was asked how it came to pick Denver-based Aytu to distribute its rapid test kits for novel coronavirus antibodies last week.
The SGX also asked what the financial impact could be to Biolidics from ongoing probes into claims that Aytu supplied healthcare providers with coronavirus tests from unapproved Chinese manufacturers and may have breached United States securities laws.
Biolidics said that it was introduced to Aytu by a Denver-based business associate in end-March and was aware of media reporting on the alleged distribution of unauthorised test kits.
Still, it went ahead with its distributorship agreement on April 23 because it believed, after carrying out due diligence such as an assessment of Aytu&rsquo s financial standing and track record, that the company would be a suitable distributor for its own coronavirus test kits.
Biolidics said that it has not verified the claims or sought legal advice in the United States, but added law firms&rsquo probes of Aytu &ldquo may be considered &lsquo attorney advertising&rsquo &rdquo under US rules.
&ldquo While the company is not privy to the grounds of investigation of potential claims on behalf of purchasers of Aytu against Aytu, the company believes that it would not be impacted by news on such investigation,&rdquo said Biolidics.
It noted that it can appoint another distributor if a contractual minimum purchase quantity is not met, or immediately terminate the agreement if terms are breached by Aytu or sub-distributors.
Separately, the board told the Securities Investors Association (Singapore), or Sias, that an executive&rsquo s remark about commissioning some two million test kits in two months &ldquo was referring to the intended build-up in inventory in anticipation of orders for the test kits and not firm orders&rdquo .
&ldquo As such, the company would like to clarify that the statement should not be interpreted as a projection by management,&rdquo Biolidics added.
&ldquo The decision on the order volume by the company in the next two months will be dependent on the sales volume as well as availability of capital and human resources.&rdquo
To another question from Sias, on how Biolidics adds value to test kits that are made by a Chinese supplier in Nanjing, the company said that &ldquo such information is commercially sensitive&rdquo .
&ldquo The disclosure of such information may negatively impact the competitive strength of the company,&rdquo it asserted, while clarifying that the test kits do not make use of Biolidics&rsquo patented technology to extract tumour cells from small amounts of blood.
Biolidics reiterated to shareholders that it &ldquo is actively developing the market for the test kits&rdquo in Singapore, the Philippines, the European Union and the US, and seeking regulatory approval elsewhere, although it also specified that it has not submitted any application to Indonesia.
guards80 ( Date: 26-Apr-2020 22:39) Posted:
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Bio is a distributor of Nanjing.
Aytu is a distributor of bio.
All these sounds very familiar to me.
Reseller
Also can make money LA. If the products can sell.
Only scare cannot sell nia
Just go read the company announcement and decide for yourself.
Be it a distributor or maker.
End of the day. It's the sales in US tats important.
If aytu can sell millions?
If FDA reject the kits....
If if if.
All come. Back to. Sales figures.
go read ho ching. double whammy.
shadow11 ( Date: 26-Apr-2020 23:25) Posted:
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Wah kaoz.
I read and read.
They are just a distributor only.
Taking product from maker and relabel biolidic.
I read and read.
They are just a distributor only.
Taking product from maker and relabel biolidic.
Very good summary and research, thanks for sharing!
Trader-101 ( Date: 26-Apr-2020 17:04) Posted:
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Saw this too... sigh... so many bumpers
guards80 ( Date: 26-Apr-2020 22:50) Posted:
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No worries, but from the header itself, I believe it' s just a neutral stand article. Neither a good news nor a bad news I believe:)
guards80 ( Date: 26-Apr-2020 22:50) Posted:
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Ho Ching sort of hinted it is a scam??? That day 0.885, then 0.425, 0.39 low, perhaps go back to 0.18 can punt? Or steer clear? Want to make back come to more Medical Stars: you want stable come Medtecs. You want shoot for the moon OEL? or perhaps E-Development? Party just started for the Medical Bull or some say Casino.
| guards80 ( Date: 26-Apr-2020 22:48) Posted: |
i also didn' t subscribe not sure why must pay to see this news lol
Masterwei ( Date: 26-Apr-2020 22:41) Posted:
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share full article lei. got pay wall. Monday gap down ah?
guards80 ( Date: 26-Apr-2020 22:39) Posted:
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Thank you for sharing but sadly, I didn' t subscribe so cannot read the article
guards80 ( Date: 26-Apr-2020 22:39) Posted:
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Biolidics unlikely to be affected by allegations against coronavirus test kit distributor: Board
http://www.businesstimes.com.sg/companies-markets/biolidics-unlikely-to-be-affected-by-allegations-against-coronavirus-test-kit
What' s is to be scary the very most it drops to where it started. If you don' t play contra, just hold it
humbleman ( Date: 26-Apr-2020 22:09) Posted:
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There is some announcement made on Aytu relationship with Biolidics... seems that they can terminate their exclusive right anytime if AYTu has any issues with helping Bio to distribute the products.
The only news we wait now is the approval by FDA USA asap if they approve it for sale in USA.
The only news we wait now is the approval by FDA USA asap if they approve it for sale in USA.
According to Kelly Wroblewski, director of the infectious disease programs for the Association of Public Health Laboratories, &ldquo If you are getting an antibody test and it&rsquo s being conducted in your physician&rsquo s office, it&rsquo s a red flag&rdquo . No actions have been taken against doctors thus far.
How to get sales
How to get sales
humbleman ( Date: 26-Apr-2020 22:09) Posted:
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Be careful!
For those not aware, must read. Scary tomorrow
For those not aware, must read. Scary tomorrow
Dusktilldawn ( Date: 26-Apr-2020 18:55) Posted:
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WHO has published guidance on adjusting public health and social measures for the next phase of the COVID-19 response.1 Some governments have suggested that the detection of antibodies to the SARS-CoV-2, the virus that causes COVID-19, could serve as the basis for an ?immunity passport? or ?risk-free certificate? that would enable individuals to travel or to return to work assuming that they are protected against re-infection. There is currently no evidence that people who have recovered from COVID-19 and have antibodies are protected from a second infection.
The measurement of antibodies specific to COVID-19
The development of immunity to a pathogen through natural infection is a multi-step process that typically takes place over 1-2 weeks. The body responds to a viral infection immediately with a non-specific innate response in which macrophages, neutrophils, and dendritic cells slow the progress of virus and may even prevent it from causing symptoms. This non-specific response is followed by an adaptive response where the body makes antibodies that specifically bind to the virus. These antibodies are proteins called immunoglobulins. The body also makes T-cells that recognize and eliminate other cells infected with the virus. This is called cellular immunity. This combined adaptive response may clear the virus from the body, and if the response is strong enough, may prevent progression to severe illness or re-infection by the same virus. This process is often measured by the presence of antibodies in blood.
WHO continues to review the evidence on antibody responses to SARS-CoV-2 infection.2-17 Most of these studies show that people who have recovered from infection have antibodies to the virus. However, some of these people have very low levels of neutralizing antibodies in their blood,4 suggesting that cellular immunity may also be critical for recovery. As of 24 April 2020, no study has evaluated whether the presence of antibodies to SARS-CoV-2 confers immunity to subsequent infection by this virus in humans.
Laboratory tests that detect antibodies to SARS-CoV-2 in people, including rapid immunodiagnostic tests, need further validation to determine their accuracy and reliability. Inaccurate immunodiagnostic tests may falsely categorize people in two ways. The first is that they may falsely label people who have been infected as negative, and the second is that people who have not been infected are falsely labelled as positive. Both errors have serious consequences and will affect control efforts. These tests also need to accurately distinguish between past infections from SARS-CoV-2 and those caused by the known set of six human coronaviruses. Four of these viruses cause the common cold and circulate widely. The remaining two are the viruses that cause Middle East Respiratory Syndrome and Severe Acute Respiratory Syndrome. People infected by any one of these viruses may produce antibodies that cross-react with antibodies produced in response to infection with SARS-CoV-2.
Many countries are now testing for SARS-CoV-2 antibodies at the population level or in specific groups, such as health workers, close contacts of known cases, or within households.21 WHO supports these studies, as they are critical for understanding the extent of ? and risk factors associated with ? infection. These studies will provide data on the percentage of people with detectable COVID-19 antibodies, but most are not designed to determine whether those people are immune to secondary infections.
Other considerations
At this point in the pandemic, there is not enough evidence about the effectiveness of antibody-mediated immunity to guarantee the accuracy of an ?immunity passport? or ?risk-free certificate.? People who assume that they are immune to a second infection because they have received a positive test result may ignore public health advice. The use of such certificates may therefore increase the risks of continued transmission. As new evidence becomes available, WHO will update this scientific brief.
The measurement of antibodies specific to COVID-19
The development of immunity to a pathogen through natural infection is a multi-step process that typically takes place over 1-2 weeks. The body responds to a viral infection immediately with a non-specific innate response in which macrophages, neutrophils, and dendritic cells slow the progress of virus and may even prevent it from causing symptoms. This non-specific response is followed by an adaptive response where the body makes antibodies that specifically bind to the virus. These antibodies are proteins called immunoglobulins. The body also makes T-cells that recognize and eliminate other cells infected with the virus. This is called cellular immunity. This combined adaptive response may clear the virus from the body, and if the response is strong enough, may prevent progression to severe illness or re-infection by the same virus. This process is often measured by the presence of antibodies in blood.
WHO continues to review the evidence on antibody responses to SARS-CoV-2 infection.2-17 Most of these studies show that people who have recovered from infection have antibodies to the virus. However, some of these people have very low levels of neutralizing antibodies in their blood,4 suggesting that cellular immunity may also be critical for recovery. As of 24 April 2020, no study has evaluated whether the presence of antibodies to SARS-CoV-2 confers immunity to subsequent infection by this virus in humans.
Laboratory tests that detect antibodies to SARS-CoV-2 in people, including rapid immunodiagnostic tests, need further validation to determine their accuracy and reliability. Inaccurate immunodiagnostic tests may falsely categorize people in two ways. The first is that they may falsely label people who have been infected as negative, and the second is that people who have not been infected are falsely labelled as positive. Both errors have serious consequences and will affect control efforts. These tests also need to accurately distinguish between past infections from SARS-CoV-2 and those caused by the known set of six human coronaviruses. Four of these viruses cause the common cold and circulate widely. The remaining two are the viruses that cause Middle East Respiratory Syndrome and Severe Acute Respiratory Syndrome. People infected by any one of these viruses may produce antibodies that cross-react with antibodies produced in response to infection with SARS-CoV-2.
Many countries are now testing for SARS-CoV-2 antibodies at the population level or in specific groups, such as health workers, close contacts of known cases, or within households.21 WHO supports these studies, as they are critical for understanding the extent of ? and risk factors associated with ? infection. These studies will provide data on the percentage of people with detectable COVID-19 antibodies, but most are not designed to determine whether those people are immune to secondary infections.
Other considerations
At this point in the pandemic, there is not enough evidence about the effectiveness of antibody-mediated immunity to guarantee the accuracy of an ?immunity passport? or ?risk-free certificate.? People who assume that they are immune to a second infection because they have received a positive test result may ignore public health advice. The use of such certificates may therefore increase the risks of continued transmission. As new evidence becomes available, WHO will update this scientific brief.