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BIO PHARMA company do research on MEDICAL DISEASES
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earthdragon
Senior |
12-Jun-2020 16:05
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National Cancer Institute' s (NCI) analysis of COVID-19 IgG/IgM Rapid Test Cassette Reported 100% Combined Sensitivity, and 97.5% Combined Specificity for the Lateral Flow Immunoassay ENGLEWOOD, CO / ACCESSWIRE / June 9, 2020 / Aytu BioScience, Inc. (AYTU), a specialty pharmaceutical company (the " Company" ) focused on commercializing novel products that address significant patient needs announced today that the U.S. Food and Drug Administration (the " FDA" ) has published data from the National Cancer Institute' s (NCI) Frederick National Laboratory for Cancer Research, and its evaluation of the COVID-19 IgG/IgM Rapid Test distributed by the Company. A well-characterized panel of 30 confirmed SARS-CoV-2 antibody positive, and 80 SARS-CoV-2 antibody-negative samples collected prior to 2020 were tested in an independent validation study performed by the NCI. 96.7% and 100% sensitivity were estimated for IgG and IgM, respectively. 97.5% and 100% specificity were estimated for IgG and IgM, respectively. Furthermore, combined sensitivity and specificity were 100% and 97.5%, respectively.
Josh Disbrow, Chief Executive Officer of Aytu BioScience, commented, " This independently-conducted study by the National Cancer Institute further establishes the clinical validity of this rapid test in identifying patients with an adaptive immune response to SARS-CoV-2. As one of only four lateral flow SARS-CoV-2 immunoassays to receive an Emergency Use Authorization from the U.S. FDA, it is important that clinicians understand the performance of the independently validated assays as they select an appropriate test for clinical use." The COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a qualitative test for the detection and differentiation of IgM and IgG antibodies against SARS-CoV-2 in whole blood, plasma (Li+-heparin, K2-EDTA and sodium citrate), and serum. The product is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Emergency Use Authorization of the COVID-19 IgG/IgM Rapid Test Cassette was granted by the FDA on May 29, 2020 to Healgen Scientific, LLC, the U.S. subsidiary of manufacturer Zhejiang Orient Gene Biotech, Limited. Aytu BioScience announced a U.S. distribution agreement to distribute the Zhejiang Orient Gene rapid test on March 10, 2020. EUA Serology Test Performance link: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/eua-authorized-serology-test-performance
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Sgvale
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12-Jun-2020 12:02
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It will be a catalyst for the otherwise dismal price for weeks.
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Laurenpanna
Veteran |
12-Jun-2020 11:11
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Do you know when they will share Sales Update? Anyone track whether FDA is approved for them?
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shareluck
Veteran |
12-Jun-2020 11:07
Yells: "buy share also need some luck to win " |
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will hit 0.50 be patient if release good sales order |
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Sgvale
Supreme |
12-Jun-2020 10:49
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Waiting patiently for Biolidics test kits sales order update. | |||||||||||||||||||||||||
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zillion
Master |
12-Jun-2020 10:46
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Chart shows it is back to its style sideways until news come out. Play contra can get losses. Going forward medical experts expect anothe covid19 wave. Only medical, pharma, healthscience sectors will be in the limelight during covid19. | |||||||||||||||||||||||||
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WBdisciple
Elite |
12-Jun-2020 06:56
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Four of the five new community cases are asymptomatic Four of the five community cases reported yesterday do not have Covid-19 symptoms and were detected through proactive screening, said the Ministry of Health (MOH). All four, who hold work passes or work permits, are either in essential services or are contacts of previous cases. One is a security guard at a dormitory in Tampines Street 62, another is a worker in an unspecified essential service, and the other two are housemates of previously confirmed cases and were already under quarantine. The fifth community case and the only Singaporean is a 78-year-old man who began showing symptoms on June 4. He is currently unlinked to previous cases. MOH said three of the five are no longer infectious, and may have been infected some time ago. Results for the other two are pending. The average number of new daily community cases has gone up from six cases two weeks ago to eight in the past week. Unlinked community cases have also increased from one to four over the same period. Migrant workers living in dormitories make up the other 416 new cases. Also, a 44-year-old Indian male national who died on Monday of ischaemic heart disease was found to have Covid-19 on Wednesday. He had developed chest and abdominal pain on May 28, and had sought treatment at a general practitioner' s clinic. On Monday, he was found unconscious in his home and was taken to the Singapore General Hospital, where he died. Update on cases NEW CASES: 422 In community: 5 (1 Singaporean, 2 work pass holders, 2 work permit holders) In dormitories: 416 ACTIVE CASES: 12,076 In hospitals: 227 (2 in ICU) In community facilities: 11,849 DEATHS: 25 PATIENTS WITH COVID-19 WHO DIED FROM OTHER CAUSES: 10 TOTAL DISCHARGED: 27,276 Discharged yesterday: 753 TOTAL CASES: 39,387 Nine other people have died of other causes while testing positive for Covid-19. Twenty-five others have died of the coronavirus. As for the list of public places visited by Covid-19 patients while they were still infectious, Pioneer Mall and FairPrice Xtra at Jem have been added to the list, and those who were there during the specified times should monitor their health for two weeks. One infected person was at the Jem supermarket on June 6 from 3pm to 4pm, and another was at Pioneer Mall on June 8 from 9am to 10.15am. Six new dormitory clusters were announced yesterday. They are at 15 Kaki Bukit Crescent, 9 Kian Teck Drive, 1A Pioneer Sector Walk, Potong Pasir Avenue 1, 214 Tagore Lane and 200A Tuas South Boulevard. With 753 new cases discharged yesterday, a total of 27,276 patients have fully recovered from the disease. A total of 227 patients remain in hospital, including two in intensive care, while 11,849 are recuperating in community facilities. |
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ST3-trading
Senior |
11-Jun-2020 17:19
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2nd wave still drop
this fda also one kind
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donnycheh
Member |
11-Jun-2020 16:54
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Going back to test 40 cents again. Hope it holds up | |||||||||||||||||||||||||
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Laurenpanna
Veteran |
11-Jun-2020 16:54
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good for biolidics then Now just hope for them to flash good news. I see their price strong at 0.41 point. Not bad
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Sgvale
Supreme |
11-Jun-2020 16:51
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Investors were also spooked by Federal Reserve warnings over the US recovery and signs of a second wave of infections in parts of the country. | |||||||||||||||||||||||||
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ST3-trading
Senior |
11-Jun-2020 14:29
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Dropped | |||||||||||||||||||||||||
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zillion
Master |
11-Jun-2020 12:43
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Finally Spore companies will be doing its contribution to fight covid19. | |||||||||||||||||||||||||
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Sgvale
Supreme |
11-Jun-2020 12:28
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Demand of medical necessities has shifted from prevention ( masks & gloves) to detection & cure ( test kits & vaccines) post countries exiting lockdown. Biolidics should update its sales order for its test kits in US, Philipinnes, Indonesia & EU | |||||||||||||||||||||||||
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Fluffyclouds
Master |
11-Jun-2020 09:30
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Correct!
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Laurenpanna
Veteran |
11-Jun-2020 09:26
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i like their gesture of donation. Shows that while making money, they still care for the world. If they can donate, means they should be making much too. That is my personal feeling |
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ST3-trading
Senior |
11-Jun-2020 09:23
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dropped | |||||||||||||||||||||||||
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Sgvale
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11-Jun-2020 09:05
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Test kits are in even more in demand post coronavirus/ countries exiting lockdowns. It will cost economies more should 2nd or 3rd waves come.
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Sgvale
Supreme |
11-Jun-2020 08:53
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Indonesia has seen orders of test kits made overseas being cancelled and in some instances hijacked by other countries as it grapples with the coronavirus which has infected more than 33,000 people and killed over 1,900 in the country. Indonesia start ups to boost local production of test kits.. | |||||||||||||||||||||||||
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Laurenpanna
Veteran |
10-Jun-2020 17:24
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could it be the news of Biolidics donating cash and Masks to Mongolia? | |||||||||||||||||||||||||
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