Approval of Sona Nanotech’s test delayed
There was another setback on Wednesday for Dartmouth-based COVID-19 test maker Sona Nanotech Inc.
The company, which describes itself as a developer of rapid point-of-care diagnostic tests, announced it withdrew its application for an interim order authorization from Health Canada for the marketing of its rapid COVID-19 antigen test.
The company said in a news release that withdrawing the application was based on feedback it has received from Health Canada.
Now, Sona Nanotech management said, the company will go back to work to obtain more clinical data to augment its submission.
Listed on the Canadian Securities Exchange under the ticker symbol SONA, the stock dipped below a dollar per share early Thursday but recovered to close near $1.17. Shares in Sona Nanotech have a 52-week high of $16.01 per share and had traded as low as one cent during that same 52-week period.
The Dartmouth company also trades in the over-thecounter market, under the symbol SNANF.
New York-based Rosen Law Firm, which specializes in investor rights, announced on Thursday that it is investigating “potential securities claims on behalf of shareholders of Sona Nanotech Inc. (OTC: SNANF) resulting from allegations that Sona may have issued materially misleading business information to the investing public.”
A representative from Sona Nanotech could not immediately be reached for comment Thursday.
In late October, Sona Nanotech experienced a setback in its effort to bring its rapid COVID-19 test to the U.S. market. The company was informed by the U.S. Food and Drug Administration that its request for emergency use authorization for the marketing of its antigen test in the United States was “not a priority,” which meant such authorization was not issued.
Sona Nanotech CEO David Regan told me at that time that the U.S. decision had not been unexpected. The FDA had recently updated the template for rapid antigen test applications, he said, “and while we submitted (an application) some time ago ... under their prior template, (the FDA) updated their template which put greater emphasis on the ability to distribute and manufacture. So, we figure that had a big bearing (on the decision).”
The Rosen Law Firm said in a news release that word of the Oct. 29 decision by the FDA caused Sona Nanotech's share price to fall from a close of $5.77 on Oct. 28 to close at $3 on Oct. 29, a drop of 48 per cent.
Now, following the announcement by the company about its withdrawal, Sona shares fell from a Tuesday close of $2.30 to close on Wednesday at 74 cents, a drop of more than 67 per cent, according to the Rosen statement.
In its latest news release Thursday, Sona Nanotech stated that the company is committed to working with regulators to provide additional information and analysis on its test and to resubmitting its application as quickly as possible.
“In addition to continuing to pursue approval of the company's rapid COVID-19 antigen test, which uses a nasal pharyngeal swab, Sona Nanotech management said it continues to validate its saliva sample-based version of the test. It intends to seek a large-scale trial specifically for its saliva-based test,” the firm said in the release.
Sona Nanotech states that its rapid COVID-19 antigen test offers results within 15 minutes, using a pregnancy-type lateral flow test that is easy to administer and interpret by non-experts without the need for either laboratory equipment or a device to read its results.
The company stated in the release that its research is underpinned by proprietary, patent-pending, gold nanorod technology, and “its test showed 85 per cent agreement to (real-time) results in patients in an in-field study of 99 patients and 96 per cent sensitivity in laboratory studies.”
Sona's gold nanorod particles are free of CTAB (cetyltrimethylammonium ), eliminating the toxicity risks associated with the use of other gold nanorod technologies in medical applications, the company said in the release. Management said it expects its gold nanotechnologies may be adapted for use as a safe and effective delivery system for multiple medical treatments. Those uses, Sona added, are pending the approval of various regulatory boards, including Health Canada and the FDA.
Sona Nanotech president and chief scientific officer Darren Rowles was quoted in the company release Wednesday, saying: “We have confidence in our rapid COVID-19 antigen test and its ability to detect the virus, especially within the first week of symptom onset. The regulatory approval path for antigen tests is new with evolving guidelines and Sona's test is unique, creating a challenging environment for test developers and regulators alike. We are, however, committed to obtaining the data needed to successfully achieve authorizations.”
The company stated that it “is not making any express or implied claims that its product has the ability to eliminate, cure or contain the COVID19 virus (or SARS-2 coronavirus) at this time.”