Inify Laboratories receives accreditation as a medical laboratory

         

Inify Laboratories, a unique laboratory service that provides cancer diagnostics in pathology, has received accreditation as a medical laboratory according to the ISO 15189 standard.

 

"To be accredited within five months of launching a completely unique laboratory service for cancer diagnostics must be some kind of record. It is yet another confirmation of the ability, quality awareness, and breadth of knowledge that Inify possesses," says Fredrik Palm, CEO of Inify Laboratories.

 

"For Inify, this is proof that our business lives up to the high standards we set for ourselves. Going through the accreditation process has involved the entire organization, where the whole team has contributed with expertise and commitment to get every piece in place. We intend to proudly maintain and further develop what this accreditation means for us, namely a culture of quality thinking and continuous improvement, which permeates all parts of the business," says Johanna Karling, Chief Quality Officer at Inify Laboratories.

 

Accreditation is an international system with common legislation within the EU.

It can be issued to businesses and establishments that carry out sampling and controls, such as medical laboratories. In Sweden, the authority that issues accreditation is Swedac. A competence assessment is carried out through an independent quality review of the organization.

Inify has undergone the audit, which includes a review of the business's routines and processes for quality management, competence requirements and documentation, to verify that the business meets applicable requirements and standards. Now that Swedac has confirmed that Inify Laboratories meets the requirements set for a medical technology laboratory, an accreditation certificate has been issued.

 

Healthcare institutions, especially within the public sector, often have internal requirements to primarily source their laboratory services from accredited medical laboratories.

 

"This is one of the main keys to the market, enabling us to accelerate our journey towards offering high-quality cancer diagnostics with short, predictable response times to as many patients as possible," says Palm. 

Inify Laboratories - Successful laboratory launch in Q2 with delivery of first prostate cancer diagnosis

                

 Inify Laboratories, a unique laboratory service that provides cancer diagnostics within pathology, successfully launched in the second quarter 2023.

 

“We launched our laboratory service in mid-June, completely according to plan. The interest is high, and we already see the first revenue streams,” says CEO Fredrik Palm at Inify Laboratories.

 

Since the opening, the response time – from the collection of samples until the customers have an electronically structured, easy-to-read report – has been well within the promised time.

 

“The secret behind our short, predictable response times – a major challenge for many laboratories – is that we have had the opportunity to build our laboratory from scratch, with a common goal: to create tomorrow's laboratory, offering world-class cancer diagnostics,” says Laboratory Manager Emelie Edvigsson at Inify Laboratories.

 

The company has entered into several strategic partnerships, one with the Swedish branch of Loomis. Loomis is a global value transport company responsible for transport of samples from clinics to Inify’s laboratory, as well as storage and distribution of packaging materials.

 

“During the period, we have started collaboration with important partners, with whom we signed agreements earlier in the year. These partnerships strengthen our offer while demonstrating our innovative way of thinking,” says Palm.

 

Inify’s close dialogue with clinics during the setup phase has been instrumental for starting the revenue flow. Customers were well prepared, and several of them sent samples as soon as the service was launched.

 

“Ever since the launch, we have continuously received biopsies for sample preparation and diagnosis, which serves as initial proof that the Inify business model works,” says Palm.