Connect with us

Hi, what are you looking for?


Dev’t of local diagnostics slowed by supply chain woes, regulations


By Patricia B. Mirasol

The coronavirus disease 2019 (COVID-19) pandemic has exposed the limitations of relying on a few global manufacturers for medical diagnostic exams, according to Medecins Sans Frontieres (Doctors Without Borders).

In a recent webinar organized by the medical humanitarian organization, panelists confirmed that pre-pandemic efforts to create local networks and manufacturing capacities need to be realized.

“The reason why we’re developing local diagnostics is so we can bring them to the places that do need them,” said Ricardo Jose S. Guerrero, research fellow at Ateneo Research Institute for Science and Engineering, and engineering lead at Bayan Biomedical Research Group. “We need local production to increase our healthcare resilience.”

Several projects under the Department of Science and Technology’s Philippine Council for Health Research and Development are working toward this aim.

Among them are the microPCR (miPCR) device, a more affordable alternative to commercial qPCR (quantitative polymerase chain reaction) instruments, which paves the way for more testing laboratories; and the SWIFTeR molecular test, which seeks to remove the equipment and training overhead required for reverse transcription (RT)-qPCR testing.

Meanwhile, the Integrated Protein Research and Development Center, a facility that aims to open next year, will develop the technology required for the production of proteins used by the biomedical, agricultural, and food industries.

The proteins that will be produced in this facility, said Mr. Guerrero, make up a large bulk of the costs of COVID-19 kits.

“The local production of raw and semi-finished materials will reduce the costs of the final end products,” he said, noting that the savings from these could then be passed on to patients.

There are three roadblocks to local diagnostics research and production, according to Mr. Guerrero: the procurement process and supply chain; medical device regulations; and intellectual property and interest.

A piece of equipment his team needed, for instance, took seven months to procure because there were no local suppliers. “If there were, then we could pivot faster, research faster,” he said. “This is something that was exacerbated by the pandemic, but it had always been there.”

Regulations pose a second challenge, since no implementing rules and regulations exist based on ASEAN’s MDD (medical device directive) for IVD (in-vitro diagnostics) devices. Medical devices are not IVDs, per Mr. Guerrero, and yet most COVID-19 tests and machines for point-of-care are.

Meanwhile, administrative orders (AO) issued by the Philippine Food and Drug Administration (FDA) — such as AO 2018-002 or Guidelines Governing the Issuance of an Authorization for a Medical Device — assume all medical devices are imported.

“There is no clear pathway on how devices created inside our universities can get to market,” Mr. Guerrero said.

To navigate these challenges, he proposed establishing a scientific supplier directory, and closer coordination between research funders and the FDA.

“How do we use research, funded by taxpayer money, to actually benefit taxpayers by bringing our technology to the healthcare system?” asked Mr. Guerrero. “This entails easier access to regulatory and certification expertise for academic researchers, because academic researchers … are not necessarily entrepreneurial nor good at supply chain and logistics.”

Your information is secure and your privacy is protected. By opting in you agree to receive emails from us. Remember that you can opt-out any time, we hate spam too!



REUTERS Shares of Germany’s largest bank Deutsche Bank plunged on Friday as investors fretted that regulators and central banks have yet to contain the...


US President Joseph R. Biden (left) and Canada Prime Minister Justin Pierre James Trudeau (right) original images from Reuters OTTAWA – US President Joe Biden and...


STOCK PHOTO Image by F1 Digitals from Pixabay LONDON – Most patients admitted to hospitals with acute viral infections are given antibiotics as a precaution against...


SYDNEY, – New Zealand Foreign Affairs Minister Nanaia Mahuta said on Saturday she had expressed concerns over the South China Sea and tensions in the Taiwan...


REUTERS WASHINGTON/NEW YORK – The banking crisis set off by the swift collapse of Silicon Valley Bank has exposed a sharp disconnect between Washington and Wall Street....


Intel Co-Founder Gordon Moore link: SAN FRANCISCO – Intel Corp. co-founder Gordon Moore, a pioneer in the semiconductor industry whose “Moore’s Law” predicted a steady rise...

You May Also Like


COVID-19 has had a significant impact on the mental health of Filipinos across different groups all over the archipelago. From frontline workers, parents balancing...


REUTERS By Luz Wendy T. Noble, Reporter The country’s foreign exchange buffers slightly increased as of end-October as the value of the central bank’s...


BW FILE PHOTO GROSS BORROWINGS by the National Government reached P2.6 trillion as of end-September as it continued to raise funds to respond to...


KARASOLAR.COM TENA, Ecuador — Ecuador’s rainforest Achuar people say their ancestors long dreamed of a “fire canoe” or “electric fish” that would let them...

Disclaimer: Respect, its managers, its employees, and assigns (collectively "The Company") do not make any guarantee or warranty about what is advertised above. Information provided by this website is for research purposes only and should not be considered as personalized financial advice. The Company is not affiliated with, nor does it receive compensation from, any specific security. The Company is not registered or licensed by any governing body in any jurisdiction to give investing advice or provide investment recommendation. Any investments recommended here should be taken into consideration only after consulting with your investment advisor and after reviewing the prospectus or financial statements of the company.

Copyright © 2022 Respect Investment. All Rights Reserved.