Qiagen NV added to its growing roster of panels cleared by the U.S. FDA in 2024 with the agency’s nod for its Qiastat-Dx Meningitis/Encephalitis assay. The clearance validates Qiagen’s strategy of developing rapid tests specifically for the U.S. market and builds on the respiratory, gastrointestinal and central nervous system tests already available.

Due to COVID-19, diagnostics are in the limelight, and public and private investors are watching how the pandemic may impact the in vitro diagnostics (IVD) market in the future. As the sector receives an influx of investment, companies will be in strong positions to expand their portfolios. So, with 2022 around the corner – what are the investment trends to watch?

The FDA has given a green light to Foundation Medicine Inc.’s Foundationone CDx as a companion diagnostic for Takeda Pharmaceutical Co. Ltd.’s Alunbrig to identify patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small-cell lung cancer (NSCLC). The approval comes as Laboratory Corp. of America Holdings (Labcorp) is launching a companion diagnostic to identify NSCLC patients with the KRAS mutation. NSCLC accounts for about 85% of all lung cancers, with an estimated 1.8 million new cases diagnosed each year worldwide. Of those, 3% to 5% carry the ALK gene mutation, which is often missed with standard testing methods.

Qiagen NV has started U.S. commercialization of a portable SARS-CoV-2 antigen testing device that can analyze up to 30 patient samples an hour. The Qiareach test features a portable hub device – smaller than a laptop – that can hold up to eight nasopharyngeal swab samples at a time. The test provides a digital readout of the results in two to 15 minutes – with strong positive results taking closer to two minutes and negative results coming back in 15 minutes.

Just weeks after rejecting Thermo Fisher Scientific Inc.'s overtures, Qiagen NV completed its own deal – the acquisition of the final 80.1% of diagnostics instruments company Neumodx Molecular Inc. for $248 million in cash. Qiagen, based in Hilden, Germany, bought a 19.9% stake in Neumodx back in 2018 with the option to purchase the rest for $234 million. With U.S. regulatory approval recently obtained, the deal closed with an additional $14 million in customary adjustments for cash, indebtedness, and transaction costs.

It was one of the largest med-tech deals of the year. However, Qiagen NV shareholders were apparently not satisfied by Thermo Fisher Scientific Inc.’s offer, with the voluntary public takeover bid not achieving the minimum 66.67% acceptance threshold. A total of 47% of the outstanding Qiagen shares were tendered into the offer of €43 (US$50.95) at the expiration of the acceptance period Aug. 10.

Abbott Laboratories, of Abbott Park, Ill., is the latest company to receive emergency use authorization (EUA) from the U.S. FDA for a test to detect SARS-CoV-2, the novel coronavirus responsible for the COVID-19 pandemic. The company said it is shipping 150,000 Realtime SARS-CoV-2 tests immediately to existing customers in the U.S., with plans to produce 1 million tests a week by the end of the month.

The past week has seen a lot of movement in terms of tests to detect SARS-CoV-2, the virus that causes COVID-19. “It is notable that the diagnostics community is coming together in a way we have not seen in our 20 years covering this industry,” wrote William Blair analyst Brian Weinstein in a March 14 note. “Regulators, lab professionals, and manufacturers are all in a frenetic fury to try and get testing up and running, and we generally see a sense of ‘in it together’ playing out.”

Thermo Fisher Scientific Inc., of Waltham, Mass., has made a bold play in the molecular diagnostics market, including infectious disease testing, with its proposed $11.5 billion acquisition of Qiagen NV, of Venlo, Netherlands. Word of the deal comes after reports late last year that named Thermo Fisher as a potential suitor for Qiagen. However, in late December, Qiagen said it had wrapped up a review of potential strategic alternatives and decided its standalone business plan represented the best opportunity for value creation.