MedTech 100 roundup: Small dip keeps industry down

The last month brought a bit of a skid for the medtech industry and after a slight rebound last week, the downward trend has returned.

A strong start to 2021 came to an end in late February and carried over into March, with MassDevice‘s MedTech 100 index hitting its lowest point on March 8 (102.16). It had only notched an all-time best of 110.96 on Feb. 15, leading to a fall at a level not seen since October.

While February’s highs have not yet been returned to, the industry showed signs of bouncing back last week (March 12) by finishing at 104.62.

Despite ticking up as high as 105.71 on Monday, March 15, the index regressed to the mark set the week prior, then dipped even further to end the week, coming in at 104.05 on March 19, marking a -0.5% drop week-over-week.

However, the industry remains in a better spot than it was at this time a year ago, as the index is now 12.7% up on the pre-COVID-19 pandemic high of 92.32 set on Feb. 19, 2020.<…

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Roche to acquire GenMark Diagnostics for $1.8B

Roche (SWX: RO, ROG) announced that it entered into an agreement to acquire GenMark Diagnostics (NSDQ:GNMK) for $1.8 billion.

Basel, Switzerland-based Roche is set to purchase GenMark at $24.05 per share in an all-cash transaction, totaling approximately $1.8 billion on a fully diluted basis. That represents a premium of approximately 43% to GenMark’s unaffected closing share price on Feb. 10, 2021, the final trading day before a media report speculated over a potential sale, according to a news release.

Under the agreement, Roche will commence a tender offer to acquire all outstanding shares of GenMark’s common stock and GenMark will file a recommendation statement to represent its board’s unanimous recommendation that GenMark stockholders tender their shares to Roche.

Once Roche completes the acquisition, GenMark’s principal operations will continue at its current location in Carlsbad, Calif.

GenMark develops a syndromic …

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Roche launches SARS-CoV-2 variant test for research use

Roche (SWX: RO, ROG) today announced that it has launched its Cobas SARS-CoV-2 Variant Set 1 test to detect mutations in the COVID-19 virus.

The test is designed to differentiate mutations found in variants that originated in the U.K. (B.1.1.7), South Africa (B.1.351) and Brazil (P.1). It runs on its high-volume Cobas 6800/8800 systems and is a research use only laboratory test to help scientists track mutation prevalence and assess the potential impact on diagnostics, vaccines and therapeutics.

Studies of the new variants have suggested that the variants may be linked to increased disease transmissibility and possibly decreased therapeutic and vaccine efficacy, according to the company.

“Viruses naturally evolve over time. While most mutations do not have a clinical impact, some variants need to be tracked carefully as they seem to spread more easily and quickly,” Roche Diagnostics CEO Thomas Schinecker said in a news release. “Continued surveillance is…

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FDA reports problems with Roche combo test for COVID-19 and flu

The FDA released an alert warning of false-positive results with Roche’s (SWX: RO, ROG) Cobas SARS-CoV-2 & Influenza A/B nucleic acid diagnostic.

Roche’s Cobas COVID-19/flu combo test runs on its Cobas Liat system. According to an FDA release, the false-positives may be related to two issues observed by the company.

The company observed that the assay tubes may sporadically leak and cause an obstructed optical path in the Liat analyzer, which would, in turn, produce abnormal PCR growth curves, potentially leading to invalid or erroneous positive results, particularly with Flu B.

Additionally, abnormal PCR cycling in the reaction may also produce abnormal PCR growth curves, which can lead to erroneous results. Multiple factors may cause this issue, including hardware positioning, volume movement and curve interpretation.

The FDA recommended that users of the Cobas combo test on the Cobas Liat system monitor for unexpected clusters o…

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6 notable pulmonary fibrosis research efforts 

Image courtesy of Pixabay

Idiopathic pulmonary fibrosis (IPF) is frequently a debilitating disease associated with significant morbidity and mortality. Although a rare disease, its incidence has increased in recent decades, and it leads to more deaths than some cancers. 

The treatment landscape for the condition changed in 2014 when FDA approved the first drugs indicated for IPF, nintedanib from Boehringer Ingelheim and pirfenidone from Roche (OTCMKTS:RHHBY). 

[Related: The pulmonary fibrosis treatment landscape: An expert interview]

Research on pulmonary fibrosis has increased in recent years. 

Here’s a summary of notable IPF research: 

Boehringer Ingelheim has an international study investigating a phosphodiesterase 4b (PDE4b) inhibitor in patients with idiopathic pulmonary fibrosis. Researchers have found that the drug has anti-fibrotic effects in animal models and lung fibrosis …
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Roche obtains CE Mark for rapid COVID-19 test with easier nose collection

Roche (SWX: RO, ROG) announced today that it received CE Mark approval for its new SARS-CoV-2 nasal rapid antigen test.

Basel, Switzerland-based Roche’s nasal test collects the sample from the front area of the nose instead of the nasopharynx, which is the method used with its existing SARS-CoV-2 rapid antigen test. The new method results in a simplified and faster testing procedure, according to a news release.

The new method can help reduce overall patient discomfort, particularly in sensitive individuals such as children, elderly people and those with disabilities, Roche added.

Additionally, the test offers patients the option to self-collect under the supervision of a healthcare professional, decreasing the risk of exposure to the virus for those administering the tests. Using the tests without the supervision of a healthcare professional depends on local regulatory requirements.

Roche is launching the test in partnership with SD Biosens…

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3 notable types of innovative drugs from 2020

Chemical structure of the COVID-19 therapy remdesivir. Image is from Wikipedia.

Last year, FDA approved 53 drugs, leading the industry to describe 2020 as “a strong year for new drug therapy.”

There are several drugs that stand out, according to Todd Wills, the co-author of a study that analyzes how innovative drugs are based on their structure.

The drugs that follow are examples of notable innovative therapies.

[Related: Here’s what molecular shape can tell you about pharma innovation]

1. COVID-19 therapies

One of the prominent drugs that stands out as structurally novel is remdesivir from Gilead Sciences (NSDQ:GILD). The first COVID-19 treatment to win FDA approval, remdesivir (Veklury), was first developed as an Ebola treatment. But the broad-spectrum antiviral also showed promise against the SARS-CoV-2 virus.

Gilead recently announced that sales of remdesivir beat …

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Roche test for both COVID-19 and influenza receives EUA

Roche (SWX: RO,  ROG) announced today that the FDA has granted an EUA for its Cobas SARS-CoV-2 and Influenza A/B Test for use on Cobas 6800 and 8800 systems.

The test is also available in nations accepting the European Union’s CE Mark.

The new Roche test can provide simultaneous qualitative detection and differentiation of SARS-CoV-2, Influenza A and Influenza B in people.

“With the approaching flu season, this new test is particularly important as SARS-CoV-2 and influenza infections can hardly be differentiated by symptoms alone. Now, with a single test, healthcare professionals can confidently provide the right diagnosis and most effective treatment plan for their patients,” Roche Diagnostics CEO Thomas Schinecker said in a news release.


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Roche to compete against Abbott with fast COVID-19 antigen tests

Roche (SWX: RO,  ROG) plans to launch a SARS-CoV-2 rapid antigen test that doesn’t need lab equipment to process results — similar to the test that Abbott (NYSE:ABT) recently launched.

Roche’s test will launch late this month in Europe, initially making 40 million tests available per month. The Swiss pharma and diagnostics giant plans to also seek an emergency use authorization from U.S. FDA, and will double production by the end of the year.

The test can provide results within 15 minutes. It has a sensitivity of 96.52% (positive percent agreement) and a specificity of 99.68% (negative percent agreement), based on 426 samples from two independent study centers, according to Roche.

Roche is launching the rapid antigen test in partnership with SD Biosensor, with whom Roche has a global distribution agreement

“Especially in the upcoming flu season, it is important to know whether a person has SARS-CoV-2 or the flu to ensure the righ…

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What kinds of COVID-19 tests are out there?

(Image from Mayo Clinic)

Months into the pandemic, the FDA continues to grant emergency use approval (EUA) to new tests to detect the virus that causes COVID-19 and the antibodies that indicate a person has had it.

To date, the FDA has granted EUAs for 171 tests —142 molecular tests, 27 antibody tests, and 2 antigen tests. Given the ever-changing landscape of tests for COVID-19 and the rapid rise of coronavirus cases in the parts of the country, we thought an overview of these tests might be helpful.

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

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Abbott: ID NOW COVID-19 results more accurate with earlier testing

Abbott’s ID Now test machine (Image from Abbott)

Abbott (NYSE:ABT) said today that its ID NOW COVID-19 test works better on specimens collected soon after patients begin showing symptoms.

The test’s performance has drawn fire from federal officials in recent weeks, including a recent FDA warning that the ID NOW test may return false-negative results. The agency granted the test an emergency use authorization (EUA) on March 27 and said it is now investigating whether false-negative results could be due to the types of swabs used or the type of viral transport media.

Abbott began advising customers in mid-April that ID NOW is a rapid test that was not designed for use with viral transport media. The company also recommended using dry nasal swabs to collect samples.

Today, the company announced an interim analysis of an ongoing clinical study at five urgent care clinics in New Jerse…

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