People Bio’s plan to supply the kit to diagnose Alzheimer’s to Singapore has hit a snag.

The company said in a public filing on Thursday that its contract with Singapore’s in vitro diagnosis supplier All Eights to supply Alzheimer’s diagnosis kits has been canceled by mutual consent. The contract was worth 2 billion won ($267,800), about four times higher than People Bio’s sales of 500 million won in 2020.

The contract nullification was due to delayed certification of the contract item.

People Bio had planned to supply its products for three years after All Eights registers the kit with Singapore’s Health Sciences Authority (HSA). However, the Singaporean agent has yet to register it one-and-a-half years after the contract signing.

Because of the delayed registration, People Bio, which signed the contract with All Eights in November 2011, has had to postpone its supply on two occasions.

At the time of signing the contract, People Bio expected All Eights to finish the registration process in three to six months without additional clinical trials. However, HAS revised the system afterward, making it obligatory to receive approval from one of the medical device regulators in Australia, Canada, Japan, the United States, and Europe.

Bio claimed that the product registration could be completed using HAS’s overall evaluation system and without winning approval from foreign regulators and applied for its overall assessment and registration in April 2022. However, it has finally failed to register the kit.

In Korea, People Bio recently won approval for its “inBlood OAß Test,” an oligomerized amyloid-beta test product, as a second-grade in vitro diagnostic medical device, and launched “AlzOn,” an Alzheimer’s blood test brand.