The FDA has put forth proposed rule changes that would categorise lab-developed tests as medical devices under the US Federal Food, Drug, and Cosmetic Act, according to Pacific Edge.
This alteration would necessitate the New Zealand-based cancer diagnostics company to furnish the FDA with evidence demonstrating the safety and effectiveness of their tests for their intended purposes, in addition to the existing regulatory requirements.
Pacific Edge said it was currently assessing the implications of this proposed rule change on its business but noted that it has been aware of the FDA’s intention to expand its oversight to encompass lab-developed tests for some time. The company stated that it has taken proactive measures to prepare for this potential regulatory shift, to minimise disruptions to its US operations.
The stock was down 9.9 per cent to 10.9 cents by mid-afternoon trading and ended the day down 1.3c or 10.7 per cent to 10.8c.
Trade software management firm TradeWindow fell 4.5c or 14.1 per cent to 27.5c on very light trading after announcing that tech firm nChain - which had an $11.6m agreement with the company - was set to invest $2.4m in exchange for 6,050,508 TradeWindow shares.
“During the course of Friday evening and over the weekend, it became apparent to TradeWindow that following board and management changes at nChain, the UK company is currently not in a position to make payment of the cash subscription amount as scheduled under the strategic partnership agreement,” the company said in a statement.
“TradeWindow has engaged legal counsel and intends to pursue available remedies in respect of the breach by nChain under the strategic partnership agreements.”
Spark was down 2c or 0.4 per cent to $4.79. The telco announced today it had set its sights on the gaming community with its latest project, Spark Game Arena - however, the specifics of the new endeavour remain undisclosed.
Carpet maker Bremworth jumped 4c or 8.5 per cent to 51c after the company released its annual report for its 2023 financial year. Cinema software group Vista Group rose 9c or 6.3 per cent to $1.53 while Freightways was up 29c or 3.6 per cent to $8.45.
Healthcare wholesaler Ebos Group jumped $1.07 or 3.1 per cent to $35.25 and The Colonial Motor Company was up 30c or 3.4 per cent to $9.03.
Going in the other direction, tech company Serko fell 19c or 4.4 per cent to $4.11 and KMD Brands was down 3c or 3.5 per cent to 84c.
Mainfreight fell $2.13 or 3.3 per cent to $63.05 and Auckland International Airport edged down 17c or 2.2 per cent to $7.74.
No surprises?
It’s monetary policy decision time on this side of the world this week.
Kiwibank economists said that this week, the spotlight turns to the Antipodean central banks, with the Reserve Bank of Australia (RBA) out of the gate first on Tuesday.
“Despite a change in governor, no change in policy and forward guidance are expected. A hawkish hold is the likely outcome,” they said.
The Reserve Bank of New Zealand (RBNZ) follows suit on Wednesday and it isn’t expected that New Zealand’s central bank will make any surprise moves either.
“The cash rate is expected to be left untouched - 5.50 per cent - and the statement will reaffirm the need to keep rates restrictive,” Kiwibank economists said.
“The RBNZ’s job: stabilise inflation.”
The New Zealand dollar was trading at US59.93c at 3pm in Wellington, up from US59.66c on Friday. The trade-weighted index was at 71.07, from 70.75 on Friday.