JPM: Myriad outlines turnaround plan

 Myriad Genetics CEO Paul Diaz further discussed the company's strategy to reorganize its business after several quarters of declining revenues and negative impact from the COVID-19 pandemic. After a review of its business, the company recently announced that it would focus on growing its leadership position in the women's health, hereditary cancer, and mental health segments, and concentrate on growing its presence in certain international markets, such as Germany, France, and Japan. Meanwhile, the company will sell its autoimmune business, including the Vectra DA rheumatoid arthritis test, the Myriad RBM pharmaceutical contract research services business, and the myPath Melanoma dermatology test.

As part of its international growth strategy, the company announced on Monday that it was collaborating with Illumina to create a kit-based version of its myChoice CDx for international markets. The partnership will leverage Illumina's customer base for its TruSight Oncology 500 NGS test, and Myriad's experience advancing its homologous recombination repair deficiency lab-developed test, which gauges BRCA1/2 mutations and a genomic instability score based on analysis of three DNA damage biomarkers.

Diaz said this will hopefully be one of many partnerships that will grow Myriad's international presence. Historically Myriad has taken a "go it alone" approach, he acknowledged, but as part of its reorganization, the firm will look for partnership opportunities with other companies, health systems, employers, and payors.

He highlighted the GeneSight PGx test, which helps doctors guide treatments for patients with depression and other psychiatric conditions, as another growth opportunity, particularly during the COVID-19 pandemic when people are struggling with mental health issues. The company began shipping at-home sample collection kits for the test over the summer and has noted growing interest among payors for strategies to address the mental health crisis.

Meanwhile, due to the pandemic, the company is remaining conservative and holding off on providing future revenue guidance. "Given the resurgence of COVID, and [the fact that] the last couple of days have been just horrific, one should be prepared … for a pretty flat couple of quarters," Diaz said. Even though the company has implemented new sales strategies to mitigate the impact of the pandemic, he acknowledged that "even hanging on to the gains we have made requires a lot of work."

https://www.genomeweb.com/business-news/jp-morgan-healthcare-conference-2021-day-one-roche-seer-10x-guardant-hologic-thermo#.X_37sehKjIU

JPM: Roche sees strength in diagnostics base

 Roche CFO Alan Hippe said at the conference on Monday that the firm's diagnostic test capacity and installed based has "grown significantly" along with the greater emphasis on testing during the COVID-19 pandemic.

"COVID brought testing and diagnostics to a different level," and Roche expects to benefit in the first half of 2021 from increases in its installed base and capacities, Hippe said.

"We still think that testing will be important moving [forward], especially in the first half of 2021," he said, adding that serology testing is expected to be especially important as people who have been vaccinated look to test for COVID-19 antibodies.

During the year, Roche will further ramp up capacities for its PCR, rapid antigen, and rapid antibody tests, Hippe said.

The company noted in its presentation that its installed base has grown to 1,000 for its high-throughput Cobas 6800 and 8800 analyzers, which are used to run its Cobas SARS-CoV and Cobas SARS-CoV-2 & Influenza A/B tests. The analyzers enable between about 1,500 and 4,000 tests to be processed in 24 hours. In 2021, testing capacity using these analyzers is expected to be greater than 20 million per month, according to Roche.

Meanwhile, the installed base of the firm's high-throughput e411/601/602/801 line of analyzers, which enable up to 300 tests per hour, is now around 40,000. The analyzers are used to run the Elecsys Anti-SARS-CoV-2, Elecsys Anti-SARS-CoV-2 S, SARS-CoV-2 rapid antibody, and Elecsys Anti-SARS-CoV-2 antigen tests. In 2021, testing capacities for the analyzers are expected to reach 100 million per month.

Further, Roche noted that the installed base now exceeds 5,000 Cobas Liat analyzers, which are used to run its SARS-CoV-2 and Influenza A/B point-of-care tests in about 20 minutes. In 2021, testing capacities for the Liat are expected to reach about 1 million tests per month, the firm said.

Roche further expects that its rapid antigen tests, which operate without an instrument and test for SARS-CoV-2 as well as SARS-CoV-2 & Influenza A/B, will reach a capacity of about 80 million per month in 2021.

Hippe confirmed Roche's previously announced full-year 2020 guidance for low- to mid-single-digit percent sales growth, but added that he anticipates its growth will be "perhaps more on the low-[single-digit] side."

"After a period of consolidation by the end of Q3 [and] beginning of Q4, the overall healthcare market went back into a lockdown mode …. and Q4 didn't get back as much [toward] the new normal as we had hoped for, at least not on the pharma side," he said. "During the pandemic we provided low-single-digit sales growth … while losing $5.05 billion in sales due to biosimilars competition. At the same time, we invested roughly $1 billion more into R&D, at constant rates, while defending the margin."

Within diagnostics, in the second half of 2021, the firm expects to experience a "pretty heavy base effect" because of the strength in sales of its high-throughput and point-of-care tests during the second half of 2020, Hippe said.

https://www.genomeweb.com/business-news/jp-morgan-healthcare-conference-2021-day-one-roche-seer-10x-guardant-hologic-thermo#.X_37sehKjIU

JPM: Guardant eyes launching colon cancer blood test this year

 Guardant Health CEO Helmy Eltoukhy said that his firm, formerly focused solely on blood-based cancer genotyping, plans to launch two new products this year, including a comprehensive tissue sequencing assay that would compete with tests from leaders in the space like Foundation Medicine, Caris Life Sciences, and others.

The company also intends to release a minimal residual disease test it has now dubbed GuardantReveal, formerly known as Lunar-1, by the end of the first quarter of 2021, although the long-term trials assessing the assays clinical impact are still ongoing.

Guardant said the Reveal assay has a seven-day turnaround time and is intended to detect residual disease and surveil for emerging recurrences in patients with earlier-stage cancer who have had surgery or other treatments with curative intent.

Currently the test is for use only in colorectal cancer patients, but the company is also working to validate it in additional tumor types. Unlike some other blood-based MRD tests, such as Natera's Signatera, which require upfront tissue sequencing to create patient specific liquid biopsy assays, GuardantReveal is universal and performed directly on blood without the need for tissue samples.

The firm's most recent data for the assay demonstrated 91 percent sensitivity and 100 percent specificity for recurrence detection.

Outside of these new product launches, the Redwood City, California-based firm also believes it will see growing adoption of its existing tumor genotyping tests, following the approval it received last year from the US Food and Drug Administration for the CDx version of its core assay, Guardant360.

The company believes that Guardant360 CDx — which is approved for genomic profiling of all solid tumors, and as a companion diagnostic to determine patient eligibility for the EGFR-targeting drug osimertinib (AstraZeneca's Tagrisso) — will be critical in accelerating adoption of liquid biopsy testing, especially among oncologists who have been on the sidelines with respect to comprehensive genomic profiling.

Guardant also launched an update to the LDT version of Guardant360 last year, adding both additional targets and what the firm believes to be a best-in-class blood-based calculation of tumor mutational burden.

Eltoukhy said that Guardant's 2020 Q1, Q2, and Q3 test volumes increased 60 percent, 15, percent, and 28 percent respectively year over year, growing to just under 17,000 tests in the third quarter last year, driven by further shifts in the cancer genotyping market to a blood-first paradigm, and expansion in the use of repeat testing.

But as much progress as the firm has made, it's CEO said that it's clear that Guardant is still very much in the early innings of adoption for the 700,000 patients that have metastatic disease of solid tumors, and there is "ample room" for it to further fill the lingering gap between clinical guidelines and clinical practice.

Areas outside of standard tumor profiling that the company continues to pursue for Guardant360 include the molecular assessment and tracking of therapy response.

Finally, Eltoukhy reiterated Guardant's confidence that it is on track to complete enrollment of the ongoing prospective study of its Lunar-2 colorectal cancer screening assay by the end of this year. If successful, this ECLIPSE trial is expected to play a pivotal role in a potential FDA submission.

https://www.genomeweb.com/business-news/jp-morgan-healthcare-conference-2021-day-one-roche-seer-10x-guardant-hologic-thermo#.X_37sehKjIU

Israel expects to start vaccinating children over 12 by March

 Israel may include children over the age of 12 in groups receiving COVID-19 vaccines within the next two months if research shows this is safe, a top health official said on Tuesday.

Vaccinating at a world-record pace, Israel says it aims to have administered one or both shots to 5 million of its 9 million citizens, and reopen the economy, by mid-March.

Elderly Israelis and adults with medical conditions or jobs in critical high-risk sectors have been given priority. But with Israeli officials anticipating more regular vaccine shipments, the eligibility categories have been expanded.

Nachman Ash, national coordinator on the pandemic, predicted that pharmacological research would establish that the minimum age threshold for the vaccines could be safely lowered from 16 to 12, and FDA approval for such use secured, by March.

“The fact that children under the age of 16 are not currently getting vaccinated is certainly troubling, in terms of the ability to achieve herd immunity,” he told 103 FM radio.

“I reckon that, in another month or two, there will be another cohort - the aged-12 and higher - that we can vaccinate.”

Around 7.75% of Israel’s population are between the ages of 12 and 16, according to Central Bureau of Statistics data.

https://www.reuters.com/article/us-health-coronavirus-israel/israel-expects-to-start-vaccinating-children-by-march-virus-chief-says-idUSKBN29H16G

U.S. to require negative COVID-19 tests for international air passengers

  The head of the U.S. Centers for Disease Control and Prevention (CDC) is expected to sign an order on Tuesday expanding coronavirus testing requirements for nearly all international air travelers, not just from Britain, sources briefed on the matter told Reuters.

The new rules are to take effect two weeks from the day they are signed by CDC Director Mark Redfield, which would be Jan. 26.

The CDC has been urgently pressing for an expansion of the requirements with the Trump administration for weeks. One remaining issue is how to address some countries that have limited testing capacity and how the CDC would address travel to those countries, the sources said.

The CDC on Dec. 28 began requiring almost all airline passengers arriving from Britain - including U.S. citizens - to test negative for COVID-19 within 72 hours of departure. Those under 2 and passengers connecting through the UK are exempt.

Canada imposed similar rules for nearly all international arrivals starting Jan. 7, as have many other countries.

At a White House meeting on Monday, Redfield again made an urgent case to adopt the testing requirements as new strains of COVID-19 are identified in different parts of the world. He raised concerns that vaccines could potentially not be effective against new strains, sources said.

U.S. officials do not plan to drop restrictions that were adopted starting in March that ban most non-U.S. citizens who have been in most of Europe, the United Kingdom and Brazil as soon as possible, the sources said. They added that public health officials are sympathetic to the push to lift the restrictions that apply only to a limited number of countries.

Earlier this month, major U.S. airlines backed the CDC’s push to implement a global testing program requiring negative tests for most international air passengers returning to the United States.

Airlines for America, a group that represents American Airlines, United Airlines, Delta Air Lines and other major carriers, also urged the Trump administration to lift European and Brazilian entry restrictions as part of the testing expansion.

https://www.reuters.com/article/us-health-coronavirus-airlines/u-s-to-require-negative-covid-19-tests-for-international-air-passengers-sources-idUSKBN29H2KD

Biomerica 15-Minute Simple Covid-19 Antigen Test Receives CE Mark

 

• Biomerica receives first orders and plans to ship tests in coming weeks
  

• Clinical studies demonstrated an overall performance of 94.7% positive agreement (sensitivity) and 99.7% negative agreement (specificity) as compared to lab-based molecular PCR tests

Biomerica, Inc. (Nasdaq: BMRA), a global provider of advanced medical products, today announced it has received CE Mark for its new COVID-19 Rapid Antigen Test for detection of COVID-19 infection. The Company has already received its first European orders and plans to ship the first part of these orders in the coming weeks. The Company will now begin marketing this product broadly in Europe and other regions outside of the US.

Biomerica’s new COVID-19 Antigen Rapid Test is highly portable, affordable, and provides results in 15 minutes with no equipment required to perform or read the test. Because this test can be performed by doctors, nurses, school nurses, and medical assistants, the Biomerica COVID-19 Rapid Antigen Test can be performed at the point of care, outside of medical labs, taking pressure off of labs performing COVID-19 testing. The test also provides results in 15 minutes versus lab-run PCR tests which can take up to three days for results, thereby potentially expediting the process of identifying infectious people so they don't spread the disease to others.

https://finance.yahoo.com/news/biomerica-fast-15-minute-simple-131900737.html

Bayer Gets FDA Priority Review for Finerenone in Diabetes With Chronic Kidney Disease

Bayer AG on Tuesday said the U.S. Food and Drug Administration granted priority review to finerenone for patients with chronic kidney disease and type 2 diabetes. The Leverkusen, Germany, chemical and pharmaceutical company said finerenone offers a potential new strategy to delay the progression of chronic kidney disease in people with type 2 diabetes while reducing the risk of cardiovascular events. The FDA grants priority review to medicines that have the potential to provide significant improvements in the treatment of a serious disease, and the designation shortens the review period to six months from the standard 10 months. Bayer said there is currently a significant unmet medical need for the nearly 40% of people in the U.S. with type 2 diabetes who will develop chronic kidney disease, a progressive condition can lead to kidney damage and eventual failure. https://www.marketscreener.com/quote/stock/BAYER-AG-436063/news/Bayer-Gets-FDA-Priority-Review-for-Finerenone-in-Diabetes-With-Chronic-Kidney-Disease-32177953/