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I contacted the company's PR people with a number of questions but I'm afraid very little to report back.
FDA EUA. The FDA has not formally told GDR why there is a delay.
EU Deal. This is still "live" but they don't know why there is a delay.
Sales in India. The company hopes to update the market if there are material developments.
Sales in US. Ditto.
POC. The company is likely to report on this soon.
So for the moment it is still, unfortunately, a case of jam (perhaps) tomorrow. :-(
One company sues the UK government for negative validation whilst another company supplying the UK government with over a billion tests , gets one of its tests widely used by the UK government rejected by the US government.
"Diagnostic test developer Mologic is suing the UK government over the validation of its rapid antigen test for SARS-CoV-2.
The Bedford, UK-based company said its COVID-19 Rapid Antigen Test has performed well in independent studies, but the UK government's facility, where newly developed rapid SARS-CoV-2 tests are validated, has reported 30 to 60 percent failure rates....
The UK government's testing facility has approved the use of a lateral flow antigen test developed by Innova Medical Group, which has reportedly supplied the UK government with more than 1 billion rapid tests under contracts worth more than £3 billion ($4.23 billion). The US Food and Drug Administration last week requested that the company stop sales of its Innova SARS-CoV-2 Antigen Rapid Qualitative Test and warned the public against using the test, citing concerns about its performance....
A BMJ opinion article in January warned that the "UK government is widening the rollout of the Innova lateral flow test without supporting evidence" and called on the government to change its course."
...gets an EUA.
"The agency granted EUA to STS Lab Holdco, a subsidiary of Amazon.com, for the Amazon Real-Time RT-PCR DTC Test for Detecting SARS-CoV-2. The test is authorized as a direct-to-consumer product for testing individual anterior nasal swab specimens self-collected at home using the Amazon COVID19 Test Collection Kit DTC. Any individual 18 years or older, including individuals without symptoms or other reasons to suspect COVID-19, can conduct testing."
Another company, Diabetomics, got an EUA as well.
Maybe Genedrive should take to online selling. :-)
Thermo Fisher Gets FDA Emergency Use Authorization for Pooled Sample SARS-CoV-2 Test Kit
Jun 01, 2021 | staff reporter
NEW YORK — The US Food and Drug Administration last week granted Emergency Use Authorization for Thermo Fisher Scientific's TaqPath COVID-19 Pooling Kit.
Surely we can't be far off now?
NowDiagnostics' test received the CE marking in mid-2020. our test had it in May so, assuming both companies applied for the FDA EUA around the same time as the CE mark, it looks like the FDA are not following order of submission.
FDA Grants Emergency Use Authorizations for SARS-CoV-2 Tests From Harvard, NowDiagnostics
May 26, 2021 | staff reporter
NEW YORK — The US Food and Drug Administration has granted separate Emergency Use Authorizations for a molecular SARS-CoV-2 test developed by Harvard University and a point-of-care immunoassay for the virus from NowDiagnostics.
Will our turn be coming soon??
Here is the link for the Quiagen announcement:
The latest EUA has been announced for Qiagen SARS-CoV-2 Serological Test but frustratingly there are still 27 "EUA submission pending" on the list. There have been 27 for the last several weeks.
Qiagen SARS-CoV-2 Serological Test Gets FDA Emergency Use Authorization
May 12, 2021
NEW YORK – Qiagen said after the close of the market on Wednesday that it has received Emergency Use Authorization from the US Food and Drug Administration for the QiaReach Anti-SARS-CoV-2 Total Test to identify whether a person carries antibodies to SARS-CoV-2 from a prior infection.
Here is the latest list updated today.
An old article but a reminder that GDR is a serious contender in the Indian market.
"What are the company’s unique delivery solutions involving AI, IoT, and healthcare technologies?
Witnessing the unprecedented challenges put forth by Covid-19 for global health, we formed DIVOC Health to enable innovations for a healthier world. We are using innovative products and approaches to address the needs of the Indian healthcare market. We understand that availability of accurate and high quality tests is critical to our fight against the pandemic and therefore, we identified the GeneDrive RT PCR Covid-19 tests as being particularly well suited to the Indian market due to its reduced processing steps, thermostability, and high quality manufacture."
Divoc has received accreditation for another lab in India. Hopefully this will enable the company to provide more GDR kits to alleviate the dire situation over there.
"DIVOC Ghaziabad receives both NABL and ICMR approvals for Molecular Diagnostics
Some more happy news! DIVOC Ghaziabad within one month of its operations has received the coveted National Accreditation Board of Laboratory certification. DIVOC Health is proud of this achievement and ready to serve people of Western UP, Uttarakhand and Delhi NCR with quality lab services."
Divoc Healthcare has now partly updated its website but not fully. But, as we've learnt, changes don't always happen quickly in India!
On one page:
"DIVOC has partnered with GeneDrive to bring their Genedrive® 96 SARS-CoV-2 Kit to the Indian market.
This kit has unique propositions that make it suitable for the Indian environment. It has been approved by ICMR with sensitivity rates and specificity rates of 100. "
"DIVOC is bringing GeneDrive RT PCR COVID19 Tests to India. The availability of accurate, high quality tests is critical part of India’s defence against Covid19. We identified the Genedrive test as being particularly well suited to the Indian market due to its thermostability, reduced processing steps and high quality manufacture. DIVOC has applied for regulatory clearance in India. The Indian regulatory process has recently been amended and now requires successful performance evaluation by the Indian Council of Medical Research, which DIVOC is pursuing. The Company is optimistic that India registration could be obtained. "
On this list there are 27 "EUA submission pending" listings including Genedrive though it may need updating as that was the same a week ago.
Is it in India where we have the million pounds of pending orders?? If so Divoc health are up and running ready to expedite.
"At year end over GBP1.0m of initial orders for Genedrive(R) 96 SARS-CoV-2 kit, pending regulatory approvals"
"I sold out today at a 46% loss. Just been very fed up with this going no where. I wish you all, all the best and I hope it gets back to where it was for you."
I guess it had to happen to somebody. Sold out the day before the big news. Really sorry for Northeast14 but there should still be plenty of big news to come so not all is lost if you want to get back in!