More than 18 months after first contacting the Ministry of Health about its rapid Covid-19 test, manufacturer Lucira Health has yet to receive approval for use in New Zealand.
CEO Erik Engleson, based in California but with ties to New Zealand and a second home in Wanaka, first contacted the ministry about his then soon-to-be-commercial Covid home test kits in July, 2020.
Engleson confirmed to the Herald that he was turned away at that time. He said his company is now engaged in a regulatory process to seek approval for use in New Zealand and he declined to make further comment on his earlier, failed efforts to engage with officials.
A source told the Herald Engleson's efforts in 2020 were met with a pat response from the Ministry of Health that thanked him for his offer of assistance and said that his tests were not needed.
The Lucira case appears to be representative of a variety of problems with New Zealand's planning for expanded testing, especially in light of greater border opening and a building wave of Omicron cases which will make rapid home-use kits (also called point-of-care kits) important for businesses and government services as well as individuals.
New Zealand has been very slow to even consider new testing methods like Lamp (a molecular process used by Lucira), and so far no Lamp tests have been approved for use.
While the company's Covid test has been used in the US for over a year and is also in use in Taiwan, Israel, Singapore and Canada, the Ministry of Health appears to have begun to consider approval of Lucira's test only in recent weeks.
The test uses a process called Lamp or RT-Lamp (reverse transcription loop-mediated isothermal amplification). It is self-contained, returns a result in 10 to 30 minutes, and the reliability of the process is broadly considered similar to PCR testing through the early and acutely symptomatic phases of the disease (PCR is also a molecular test).
An article published in the International Journal of Infectious Diseases in April last year made findings that: "suggest that RT-Lamp can be used as a diagnostic tool for Covid-19 as an alternative to RT-qPCR in the acute symptomatic phase of Covid-19."
In Canada Lamp tests are acceptable pre-departure tests for travel into the country. Flag carrier, Air Canada, for example, promotes and supplies the Lucira test to travellers in conjunction with the domestic supplier Switch Health. Travellers take the tests abroad with them and use them before the return flight. The sampling process must be observed remotely by Switch Health in a process described as proctoring.
Lucira's tests retail in the US for around $112 each, a price tag which makes them considerably more expensive than rapid antigen tests, but also significantly cheaper than PCR tests, the cost for which varies but is well over $200 per test in New Zealand.
Just nine rapid Covid-19 tests are approved for use in New Zealand, all of them are antigen tests. That narrow scope means that New Zealand buyers remain limited in what they can order.
Added to this, the Government's own orders were so belated that in recent weeks it has consolidated businesses' forward RAT orders into its own.
Despite redirecting the orders, a Ministry of Health spokesperson said the Government has not invoked special powers of requisition. "We have set the expectation with suppliers as part of the Public Health Response," the spokesperson said.
Business groups including the Food and Grocery Council said the orders had "been taken" regardless of what you call it.
Like many rapid test manufacturers, Engleson said his company is now struggling to keep pace with surging demand, though his ties to New Zealand mean that he is "still very interested in supplying the country … we've been in touch with Air New Zealand."
In April, 2021, the New Zealand Government renewed a 2020 "prohibition on the import, manufacture, supply, sale, packing or use of point-of-care test kits".
The following month it widened the ban to expressly include molecular point-of-care kits.
At the time, New Zealand had a very low prevalence of Covid-19 under the country's elimination policy and it was considered by many that the use of tests less reliable than PCR was unnecessary. That, however, changed very quickly following the outbreak of the Delta variant in August, 2021.
Despite this, government ministers and officials were slow to change their approach to testing, even as the country's laboratory system, supplying conventional PCR testing, struggled to keep pace with demand, and frequently failed to meet the Ministry of Health's own benchmark processing times.
Sources told the Herald that the approval process for new Covid tests in New Zealand has been part of a larger problem that has seriously slowed their arrival into the country.
In October, 2021 just three rapid tests were approved for very limited use in New Zealand, and the earlier prohibition was modified, though still subject to the strict control of director general of health, Ashley Bloomfield.
Those tests appear to have been evaluated and approved for use by the Institute of Environmental Science and Research (ESR). But there are signs that this arrangement was not suitable to meet the country's need for more rapid tests.
October 14th notes from the Ministry of Health's Covid-19 Testing Technical Advisory Group, released under the Official Information Act, note that ESR "received funding to source and assess [testing] kit performance". The minutes also note that the ESR criteria for testing kit performance "will likely be modified to be fit for purpose".
The minutes aren't entirely clear, but the inference is that ESR's assessment of new tests was slow and not suited to the relatively speedy results that were required, especially in light of critically strained laboratory facilities providing delayed PCR test results at the time.
A month earlier, in September, a report by Sir Brian Roche had called for new testing methods, particularly rapid testing, to be given much greater priority by the Government.
Government departments have failed to answer the Herald's questions about the approval process for new Covid-19 tests.
On January 26th questions were put to MBIE about the role of ESR (MBIE has monitoring responsibility for the Crown institute) in assessing new Covid tests and whether that role has passed to another entity. The next day MBIE passed the questions to the Ministry of Health, which acknowledged receipt of the questions on January 29th and has not responded since, despite daily inquiries.
Sources told the Herald that the process for approving new tests has changed recently, and that Medsafe has had some involvement, and that at least one rapid test approval process is unfolding outside Medsafe and is relying largely on approvals given by regulatory agencies in other industrialised countries. The source described the process as "haphazard".
The cost soared from $580m to $924m but output capacity is up on original expectations.