Resources In Medicine Are Continually Targeted at Controlling COVID-19 Spread

As business slows down in most sectors worldwide due to the spread of coronavirus disease 2019 (COVID-19), the biopharmaceutical industry is doubling its efforts in order to develop life-saving vaccines and diagnostic tools for use by clinicians across medical specialties. Swift actions by the FDA and other public health organizations are being taken to ensure the health care industry has the tools it needs to care for patients who may be affected by the virus.

As business slows down in most sectors worldwide due to the spread of coronavirus disease 2019 (COVID-19), the biopharmaceutical industry is doubling its efforts in order to develop life-saving vaccines and diagnostic tools for use by clinicians across medical specialties. Swift actions by the FDA and other public health organizations are being taken to ensure the health care industry has the tools it needs to care for patients who may be affected by the virus.

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As a broader picture of the effects of the virus on the medical industry becomes clear, more and more resources are being shiftedtowards measures to ensure that the spread of the virus is controlled, with widely available testing touted by many as one of the most important steps towards containing COVID-19.

Detection of COVID-19

On Friday, March 13, 2020, Thermo Fisher Scientific, Inc., a Massachusetts-based company responsible for developing both research and clinical cancer assays, announced that the FDA issued Emergency Use Authorization to its diagnostic test, the TaqPath COVID-19 Combo Kit,1for detection of SARS-CoV-2 only and not for any other viruses or pathogens.2

“The authorization of our diagnostic test for COVID-19 will help to protect patients and enable medical staff to respond swiftly to treat those who are ill and prevent the spread of infection,” Marc N. Casper, chairman, president and chief executive officer of Thermo Fisher Scientific, said in a statement.

The kit consists of both assays, TaqPath RT-PCR COVID-19 and TaqPath COVID-19 Control Kit, which can be used by clinical and public health laboratories. Up to 94 patient specimens can be evaluated in under 4 hours. Specimens can be obtained via nasopharyngeal swabs, nasopharyngeal aspirate (nasal aspirate), or bronchoalveolar lavage of patients who may have symptoms of the disease.1

The test has not received FDA clearance or approval, but the designation allows use of the products in diagnosing, treating, or preventing a disease or condition, as in the case of the novel coronavirus, after declaration of a public health emergency by secretary of the United States Department of Health and Human Services.2

Thermo Fisher Scientific is responsible for developing companion diagnostic and next-generation sequencing assays for the treatment of cancers and the development of life-saving oncology drugs. One such test is being developed in agreement with Eli Lilly and Company to assist in identifying patients with non­—small cell lung cancer and medullary thyroid cancer harboringRETvariants who may be candidates for the investigational therapy, LOXO-292.3

First Coronavirus Clinical Trial

A phase I clinical trial evaluating a COVID-19 vaccine was initiated on March 16, 2020 at the Kaiser Permanente Washington Health Research Institute in Seattle, with the first patient out of 45 healthy volunteers receiving the investigational agent on day 1.4

The open-label, dose-ranging clinical trial will assess the safety of the vaccine, called mRNA-1273, and its ability to induce an immune response. The group responsible for developing the vaccine is the National Institute of Allergy and Infectious Disease (NIAID), part of the National Institutes of Health, and is also funding the trial.

“Finding a safe and effective vaccine to prevent infection with SARS-CoV-2 is an urgent public health priority,” Anthony S. Fauci, MD, director of NIAID, said in a statement. “This phase I study, launched in record speed, is an important first step toward achieving that goal.”

Social Distancing Impact on Clinicians

Those treating patients in regular practice have similarly experienced an impact to their day-to-day routines, which has been greatly impacted by social distancing in which people deliberately maintain physical space between themselves and others to slow down the spread contagious diseases.

“I think for all of us it’s the unknown, and we’re all trying to be very flexible and nimble in our approach,” Vicki Caraway RN, BSN, Vice President of Clinical Services for American Oncology Network, said in an interview withTargeted Oncology.

With major meetings such as the National Comprehensive Cancer Network 2020 Annual Meeting,5American Association for Cancer Research Annual Meeting 2020,6and Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer7being either postponed or canceled, many are left wondering what the long-term effects of an extended quarantine could mean for forward progress in the field.

On March 16, the American Cancer Society wrote in an announcement that it would be suspending all fundraising events through the middle of May 2020 in the interest of “the health and safety of our volunteers, staff, and cancer patients and their loved ones."8

As oncologists eagerly watch the rapid developments in the fight against COVID-19, travel bans, social distancing, and deferred resources will undoubtedly have an impact on the field of medicine for some time.

“If the trend continues, since [oncology] is such a dynamic global field, it is expected to slow down some of the momentum,” Harsha Vyas, MD, president and CEO of the Cancer Center of Middle Georgia, explained in an interview. “I don’t believe it’s a permanent thing, but 2020 may not be a great year.”

<< View more resources regarding COVID-19

References:

  1. TaqPath COVID-19 Multiplex Diagnostic Solution. Thermo Fisher Scientific website. https://bit.ly/2UcUUT3. Accessed March 16, 2020.
  2. FDA issues emergency authorization to Thermo Fisher Scientific for diagnostic test used to detect COVID-19 [news release]. Waltham, MA: Thermo Fisher Scientific, Inc.; March 13, 2020. https://bit.ly/38Xo1z6. Accessed March 16, 2020.
  3. Thermo Fisher Scientific signs agreement with Lilly Oncology for companion diagnostic to be used withRETinhibitor [press release]. Carlsbad, CA: Thermo Fisher Scientific; September 9, 2019. https://bit.ly/2m4utS9. Accessed March 16, 2019.
  4. NIH clinical trial of investigational vaccine for COVID-19 begins. National Institutes of Health website. https://bit.ly/2ITwXew. Published March 16, 2020. Accessed March 16, 2020.
  5. National Comprehensive Cancer Network postpones 2020 annual conference, citing precautions against potential patient exposure to COVID-19. National Comprehensive Care Network website. bit.ly/3d49Lbg. Published March 5, 2020. Accessed March 16, 2020.
  6. AACR Annual Meeting 2020: notice of termination and rescheduling. AACR website. https://bit.ly/38QOEpn. Published March 10, 2020. Accessed March 16, 2020.
  7. 2020 Annual Meeting Coronavirus update. SGO website. https://bit.ly/2TTkXjq. Accessed March 16, 2020.
  8. American Cancer Society suspends events. American Cancer Society website. https://bit.ly/39V0KPD. Published March 16, 2020. Accessed March 16, 2020.