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Quidel, Ortho Clinical Diagnostics combine to form in vitro diagnostics company

Quidel (Nasdaq:QDEL) announced today that it completed its $6 billion acquisition of Ortho Clinical Diagnostics (Nasdaq:OCDX).

In December 2021, San Diego-based Quidel and Ortho Clinical Diagnostics came to an agreement under which the former would acquire the latter for $24.68 per share of common stock, using a combination of cash and newly issued shares in the combined company, representing a 25% premium on Ortho’s closing price on Dec. 22, 2021, and an equity value of about $6 billion.

Under the terms, former Ortho shareholders received $7.14 in cash and 0.1055 shares of QuidelOrtho common stock for each Ortho common share. Former Quidel stockholders received one share of QuidelOrtho common stock for each share of Quidel common stock, according to a news release.

Under the terms of the agreement governing the transaction, former Ortho shareholders received $7.14 in cash and 0.1055 shares of QuidelOrtho common stock for each Ortho common share. Former …

Markey wants COVID-19 test-makers to lower prices

Sen. Ed Markey, D-Massachusetts

Sen. Ed Markey, D-Massachusetts, has sent letters to CEOs of at-home COVID-19 test-makers, asking why tests are selling for as much as $12 apiece.

In a letter sent today to Abbott CEO Robert Ford, for example, Markey cited a Reuters story from October 2021 in which British test-maker Mologic said that rapid antigen tests can cost as little as $2 apiece to manufacture. “Yet, U.S. consumers face costs of $12 or more for each at-home rapid COVID-19 antigen test. As we face an unprecedented wave of COVID cases, manufacturers and retailers must do more to ensure consumers see reasonable prices for at-home tests.”

Markey made similar points to top leadership at BD, Access Bio, Quidel, Acon Laboratories, Celltrion USA, Ellume Health, iHealth Labs, InBios International and OraSure Technologies.

Get the full story on our sister site Medical Design & Outsourcing.

Democratic senator wants COVID-19 test-makers to lower prices

Sen. Ed Markey (D-Massachusetts)

Sen. Ed Markey, D-Massachusetts, has sent letters to CEOs of at-home COVID-19 test-makers, asking why tests are selling for as much as $12 apiece.

In a letter sent today to Abbott CEO Robert Ford, for example, Markey cited a Reuters story from October 2021 in which British test-maker Mologic said that rapid antigen tests can cost as little as $2 apiece to manufacture. “Yet, U.S. consumers face costs of $12 or more for each at-home rapid COVID-19 antigen test. As we face an unprecedented wave of COVID cases, manufacturers and retailers must do more to ensure consumers see reasonable prices for at-home tests.”

Markey made similar points to top leadership at BD, Access Bio, Quidel, Acon Laboratories, Celltrion USA, Ellume Health, iHealth Labs, InBios International and OraSure Technologies.

The letters could carry some weight because Markey is not only …

Quidel to acquire Ortho Clinical Diagnostics for $6B

Quidel (NSDQ:QDEL) announced today that it acquired Ortho Clinical Diagnostics (NSDQ:OCDX) for approximately $6 billion.

Under a definitive agreement,Quidel will acquire Ortho for $24.68 per share of common stock, using a combination of cash and newly issued shares in the combined company, representing a 25% premium on Ortho’s closing price on Dec. 22, 2021, and an equity value of about $6 billion.

The transaction aims to unite technologies and platforms to offer expanded access to clinical chemistry, immunoassay, molecular diagnostics, immunohematology, donor screening and point-of-care diagnostic offerings.

According to a news release, the companies expect the transaction to close during the first half of the 2022 fiscal year, subject to customary closing conditions.

“The combination with Ortho will help solidify Quidel as a leader in the diagnostics industry, bringing together innovative, complementary products, solutions, and services th…

FDA’s Woodcock reassures about COVID-19 tests, vaccines under Omicron

Acting FDA Commissioner Dr. Janet Woodcock

Acting FDA Commissioner Dr. Janet Woodcock thinks many COVID-19 tests will continue to work with the new Omicron variant — with information coming soon on vaccine efficacy.

In a statement posted yesterday, Woodcock said she thought the agency is well-positioned to work with companies to address the potential impact of viral mutations on COVID-19 tests, therapeutics, and vaccines.

“Getting vaccinated or receiving a booster with one of the currently available vaccines is the best thing that you can do right now (in addition to standard precautions like wearing a mask) to help protect yourself, your family and friends,” Woodcock said.

Discovered in late November in South Africa, the Omicron variant has more than 30 changes to the SARS-CoV-2 spike protein. The variant has enough mutations to raise concerns worldwide, even though it is still un…

Cardinal Health partners with Abbott, Quidel to expand rapid OTC COVID-19 tests

Cardinal Health today announced that it has partnered with Abbott and Quidel to broaden access to over-the-counter rapid COVID-19 tests.

Cardinal Health will use its distribution network to support access to Quidel’s QuickVue At-Home OTC COVID-19 test and Abbott’s BinaxNow COVID-19 antigen self-test. Both tests allow users to easily perform tests for the virus without a prescription.

Get the full story on our sister site, Medical Design & Outsourcing.

Cardinal Health partners with Abbott, Quidel to expand rapid OTC COVID-19 tests

Cardinal Health today announced that it has partnered with Abbott and Quidel to broaden access to over-the-counter rapid COVID-19 tests.

Cardinal Health will use its distribution network to support access to Quidel’s QuickVue At-Home OTC COVID-19 test and Abbott’s BinaxNow COVID-19 antigen self-test. Both tests allow users to easily perform tests for the virus without a prescription.

“Cardinal Health’s safe reopening offerings and broad channel presence will play a key role in widening access to testing,” Douglas Bryant, Quidel president and CEO, said. “Quidel and Cardinal Health have collaborated closely since the start of the pandemic to serve the country with these COVID-19 testing solutions. On March 17, 2020, just days after the U.S. declared COVID-19 a national emergency, we received emergency use authorization of our high throughput PCR testing platform and, that very same day, announced that we partnered exclusively w…

How ICS helped Quidel on next-gen COVID-19 diagnostics

Integrated Computer Solutions (ICS) recently announced that it served Quidel as the application developer for the next-generation molecular diagnostic system for its Savanna platform.

The goal is low-cost, point-of-care testing for a range of diseases and conditions including COVID-19, MRSA and HIV.

The Savanna project started with user experience design to create an intuitive CLIA-waived touchscreen interface and an extensible processing architecture, according to the companies. It also includes software applications and powerful, forward-looking cybersecurity for its fleet in the field.

“Supplementing our team with ICS’ skilled software engineers and designers enabled us to bring the development process in-house, resulting in a more responsive development cycle and tighter coupling with UX design,” said Johannes Kehle, VP of Savanna and managing director of Quidel Germany GmbH. “It goes without saying, this outcome couldn’t have happened at a more impe…

FDA authorizes use of over-the-counter COVID-19 tests for screening

The FDA announced today that it authorized several COVID-19 tests for over-the-counter use in asymptomatic screening.

Among the tests authorized were the BinaxNow Ag card from Abbott (which includes point-of-care screening), the Quidel Quick-View at-home test and the BD Veritor Plus system, which was authorized for POC screening with a prescription.

“BD is supporting the global efforts to return to normalcy as soon as possible, and this additional authorization for the BD Veritor system to be used in screening through serial testing of asymptomatic individuals is a large step forward,” BD life sciences president Dave Hickey said in a news release. “Frequent testing of individuals without symptoms will enable those with negative results to resume their normal school or work routines and will help to identify and isolate positive cases of COVID-19 as early as possible to prevent further spread.

“Screening through serial testing is a…

5 at-home COVID-19 diagnostic tests you should know

The wait for a completely at-home COVID-19 test ended in November when the FDA authorized the first ones that enabled people to obtain samples and results at home.

The agency has authorized five at-home COVID-19 testing kits for emergency use since the beginning of the pandemic. The kits are made to take a sample using self-administered nasal swabs. The results are delivered in less than an hour using technology similar to pregnancy tests, revealing positive or negative results.

However, there is a risk of false positives and negatives using rapid antigen tests at home, the FDA has warned. The agency said in a Dec. 15 press release that patients without symptoms who present a positive test should be treated as “presumptively positive” until it can be confirmed by another test. Patients who test negative and experience COVID-like symptoms are advised to follow up with their healthcare providers as a negative result does not rule out a SARS-CoV-2 infection.

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5 at-home COVID-19 diagnostic tests you should know

[Image from unsplash.com]

A year into the COVID-19 pandemic, the wait for a completely at-home COVID-19 test ended when the FDA authorized the first ones in November to enable people to obtain samples and results at home.

The FDA has authorized five at-home COVID-19 testing kits for emergency use since the beginning of the pandemic. The kits are made to take a sample using self-administered nasal swabs. The results are delivered in less than an hour using technology similar to pregnancy tests, revealing positive or negative results.

However, there is a risk of false positives and negatives using rapid antigen tests at home, the FDA has warned. The agency said in a Dec. 15 press release that patients without symptoms who present a positive test should be treated as “presumptively positive” until it can be confirmed by another test. Patients who test negative and experience COVID-like symptoms …