diagnostics

A battery-operated TB test designed for low-resource, high-burden settings has earned a nod from the Global Fund’s Expert Review Panel for Diagnostics, the test’s co-developer announced Monday.

Qiagen’s QIAreach QuantiFERON-TB test, co-developed with Australia-based Ellume, offers “ultrasensitive digital detection” of latent tuberculosis infection, according to an Ellume press release. The approval clears the way for the test’s procurement in countries that qualify for Global Fund or…

Quidel Corporation will buy New Jersey in-vitro diagnostic specialist Ortho Clinical for $6 billion in cash and newly issued shares, per a late December announcement from the San Diego-based company.

Expected to close in the first half of 2022, the deal will allow for “top-tier R&D capabilities, a more diverse product pipeline, and broader geographic footprint,” Quidel’s CEO said in the press release.

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The Access to Medicine (AtM) Foundation announced Tuesday that it will expand its biannual ranking of the 20 largest pharmas to include monitoring of the world’s most important generic, vaccine, diagnostics, and medical gas companies.

Citing an “unacceptable gap between the ‘haves’ and the ‘have-nots,’” an AtM press release said the Covid-19 pandemic had revealed “acute issues of access,” not only to medicines and vaccines but to medical oxygen and other essential health products.…

Public agencies in over 100 LMICs will be able to buy SD Biosensor’s STANDARD Q HIV/Syphilis Combo test for less than $1 through a collaboration between the company, the Clinton Health Access Initiative (CHAI) and Britain’s MedAccess, the partners announced Monday.

A volume guarantee agreement between MedAccess and the South Korean manufacturer will make the WHO-prequalified diagnostic available to a cohort of countries bearing 98% of the global burden of congenital syphilis and 93% of…

Japan’s Global Health Innovative Technology (GHIT) Fund will invest $6.6 million in diagnostics, drugs and vaccines development, the nonprofit announced last week.

One award will advance an ongoing Chagas disease drug development project by the Drugs for Neglected Diseases Initiative (DNDI). The five other are new projects: a TB diagnostic, a placental malaria vaccine, a malaria drug, and two separate Chagas drugs (by DNDI/Takeda and DNDI/Daiichi Sankyo).

GHIT Fund’s portfolio…

GE plans to spin off its healthcare business into a separate public company as part of a broader restructuring, the conglomerate announced Tuesday. Targeted for early 2023, the transaction would create a freestanding diagnostics specialist. GE Healthcare had $18 billion in 2020 revenue and about 47,000 employees, according to a company presentation.

GE also intends to launch its energy business as a separate entity in 2024, leaving the original GE as an aviation-focused company.

Breakthrough research in TB treatment, testing and transmission took center stage at this year’s 52nd Union World Conference on Lung Health, held virtually between October 19-22.

First, Médecins Sans Frontières (MSF) researchers presented new data from a Phase 2/3 trial showing that an investigational, all-oral, six-month regimen is safer and more successful at treating rifampicin-resistant TB than the current options. According to an MSF press release, 89% of participants in the TB-…

Some 47% of the world’s population has little or no access to basic diagnostics except those for HIV and malaria, according to a report issued last week by the Lancet Commission on Diagnostics. Access to diagnostics is the “single largest gap in the care pathway” and is most severe at the primary healthcare level, where only about 19% of people in LMICs have access to simple tests, the article said.

The Commission proposed 10 recommendations to combat the low visibility and priority of…

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Following up on its March acquisition of GenMark, Roche last week announced the purchase of longtime partner TIB Molbiol for an undisclosed price. The Swiss company said the move would expand its molecular diagnostics portfolio with a wide range of assays for infectious diseases.

Touting a natural fit, the press release noted that the two companies have collaborated for over 20 years to address biological threats—including Ebola, MERS, SARS-CoV-2 and Zika viruses—and the Berlin-based…

British diagnostics developer Mologic announced Monday that it plans to transform from a for-profit company into a social enterprise through an acquisition worth at least $41 million. The Soros Economic Development Fund is leading the takeover with support from the Gates Foundation, according to Mologic’s press release.

Under a new name—Global Access Health—the firm aims to expand affordable access to medical technology in LMICs, including tests for diseases such as bilharzia, Covid-…