University of Michigan Spin-off Company Develops Covid-19 Test

A University of Michigan spin-off company has developed a promising Covid-19 antibody test.  The press release states: 

ANN ARBOR—COVID-19 antibody testing that’s portable, fast, cheap and highly precise—four attributes that are usually mutually exclusive—could be possible with a microfluidic device invented at the University of Michigan and developed by U-M startup Optofluidic Bioassay.

A microfluidic device, or “lab on a chip,” shrinks multiple lab functions onto a single chip just millimeters or centimeters in size. The technology enables faster results with smaller sample sizes.

The new system is believed to be the first microfluidic approach to a gold standard testing protocol known as “enzyme-linked immunosorbent assay,” or ELISA. The U-M researchers have previously published results showing that their device can work as well as the slower, larger, standard ELISA setup. They are currently validating it for use on COVID-19 antibodies.

They have demonstrated that they can detect synthetic COVID-19 antibodies and they’re working with researchers at a hospital in New Jersey on experiments with human blood from COVID-19 patients.

University and industry labs around the U.S. are clambering to develop better antibody tests. The U-M approach is different in that it centers on a device, rather than the chemical mixtures, or reagents, to detect COVID-19 markers.

“We are unique because we are a hardware company,” said Xudong (Sherman) Fan, U-M biomedical engineering professor and co-founder of Optofluidic Bioassay. “Anyone working on COVID-19 antibody tests can use their reagents in our device.”

Why we need antibody tests

Rapid and accurate antibody tests could play an important role as governments, medical workers, scientists and private citizens alike continue to navigate the pandemic, the researchers say. Antibody tests can reveal who has already been exposed to the virus and developed immunity, at least temporarily, and can safely go back to work. If done in a widespread way, they could show the true scale of the pandemic and its death rate.

And the U-M researchers say their particular approach could give doctors critical, near-real-time insights into how a patient is responding to treatment, or a vaccine once one is developed.

Small-scale antibody testing has been done in some countries. Research projects are underway in the U.S. and while kits are beginning to materialize on the market here, they’re not yet widely available.

Antibody, or “serology” tests are different from the “PCR” tests being used to diagnose COVID-19. Rather than screen for the virus itself, serology tests detect antibodies—proteins the immune system manufactures to fight it.

Microfluidic ELISA in the landscape of COVID-19 antibody tests

The majority of labs working on serology kits are making a particular type called “rapid diagnostic tests” that give a yes or no reading. These are quick, but they have drawbacks. False positives can be a problem. And because they don’t give a lot of information, they aren’t useful in monitoring the immune system’s response during treatment.

A handful of labs are making ELISA tests. These are typically quantitative and accurate, showing the concentration of antibodies. That makes them more reliable and less prone to false positives than the rapid diagnostic tests. But standard ELISA results take several hours, and the machines that provide them are the size of refrigerators. In addition, the sample needs to be sent to the test lab for analysis.

But microfluidic ELISA can give a quantitative and accurate result in just 15 minutes, with a finger-prick’s worth of blood. This combination of attributes, plus the fact that it’s portable, could make it a powerful tool.

“Our approach offers the best of both worlds. We can achieve the quickness and simplicity of the rapid diagnostic test with the accuracy of the standard ELISA quantitative measure,” Fan said.

“Because our device generates such sensitive and quantitative measurements, we believe its use goes beyond identifying recovered patients. Antibodies begin to show up a few days after infection, so we could use this approach to monitor patients’ immune response to infection, treatment and vaccination.”

The microfluidic ELISA is rapid, portable and low cost.

“The estimated cost of testing is a few dollars per test of two to three different antibodies, making this a very viable option for use in hospitals, doctors’ offices, field clinics and potentially even pharmacies,” said Xiaotian Tan, a doctoral student in biomedical engineering who is working on COVID-19 antibody testing with Fan.

The machine can be the size of a microwave, and can test multiple simultaneous samples of little more than a drop of blood from a fingertip in less than 20 minutes.

It was invented at U-M several years ago and developed by Optofluidic Bioassay, which was founded by Fan and former research investigator of biomedical engineering, Maung (Malcolm) Khaing Oo, who now serves as the company’’ chief technology officer. Fan and Maung Khaing Oo are co-founders of and have an equity interest in Optofluidic Bioassay. The researchers plan to eventually apply for FDA Emergency Use Authorization.

American Antitrust Institute Materials on Competition Issues in the Healthcare Supply Chain

The American Antitrust Institute has released a collection of materials on competition issues with respect to the health care supply chain.  The Press Release states: 

The current COVID-19 public health crisis highlights the critical competition, public policy, and security issues relating to the healthcare supply chain. At a time when some functions within the healthcare system are temporarily immunized from the antitrust laws, it is essential to emphasize the importance of vigorous antitrust oversight and the benefits of competition for the welfare of consumers, healthcare workers, and innovation.

AAI has produced legal, economic, and institutional analysis of healthcare competition issues for over two decades. This evidence-based analysis touches on all aspects of the supply chain, including the adverse effects of consolidation at the provider, insurer, and intermediary levels; the debate around bargaining power; and the importance of diversity and redundancy on the stability and safety of the supply chain.

Below is a sampling of key healthcare supply chain issues for which AAI has generated research, education, and advocacy to inform and engage the antitrust enforcement and competition policy communities. This body of work also serves in a vital role to inform longer term responses to the current public health crisis and to suggest the importance of a broader public policy framework for ensuring competition in this critical sector. Note: AAI resources on competition in the pharmaceutical sector can be located separately under “Health & Pharmaceuticals” section of our website.

The resources can be found, here. 

USPTO Report on Patent Eligible Subject Matter: Greater Certainty Achieved?

The United States Patent and Trademark Office (USPTO) has released an eleven page report titled, “Adjusting to Alice: USPTO Patent Examination Outcomes After Alice Corp. v. CLS Bank International,” on the impact of Patent Office changes on patent eligible subject matter.  U.S. patent eligible subject matter law has been described by some as a “mess,” which breeds uncertainty and may impact incentives to innovate and patent.  To address the apparently conflicting and confusing state of the law, the Patent Office has worked hard to provide guidance to examiners and applicants concerning the application of the law.  The USPTO report notes that recent guidance provided by the Patent Office has had a positive effect on predictability and certainty concerning the doctrine.  Of particular interest, the guidance provided by the Patent Office has a positive impact on Alice-effected technologies.  The full report is available, here.  The Press Release states: 

WASHINGTON - The United States Patent and Trademark Office (USPTO) today published a report authored by its Chief Economist titled, Adjusting to Alice: USPTO patent examination outcomes after Alice Corp v. CLS Bank International. The report highlights how recent actions undertaken by the USPTO have brought greater predictability and certainty to the determination of patent eligibility in the technology areas most affected by the decision.

“We have heard anecdotally from both examiners and applicants across the entire spectrum of technologies that our 2019 guidance on Section 101 greatly improved the analysis in this important area of patent law,” said Andrei Iancu, Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office. “The Chief Economist’s report now confirms this general perception, especially with its critical finding that uncertainty decreased by a remarkable 44%.” 

The report’s analysis by the USPTO’s Office of the Chief Economist found that one year after the USPTO issued its January 2019 Revised Patent Subject Matter Eligibility Guidance (2019 PEG), the likelihood of Alice-affected technologies receiving a first office action with a rejection for patent-ineligible subject matter had decreased by 25%. Likewise, uncertainty about determinations of patent subject matter eligibility in the first action stage of patent examination for the relevant technologies decreased by 44% over the first year following publication of the 2019 PEG compared to the previous year.

“The primary economic function of the patent system is to provide an incentive for greater innovation,” according to Dr. Andrew Toole, Chief Economist of the United States Patent and Trademark Office and principal author of the report. “Using an evidence-based approach, our report highlights the significant impact of the Supreme Court’s Alice decision on patent examination outcomes and the important stabilizing role played by the USPTO. This is what innovators and investors need to confidently promote entrepreneurship, create jobs, and advance science and technology.”

Director Iancu added, “I have long said that in order to ensure that the United States remains the global leader in the technologies of the future, our patent system must move beyond the recent years of confusion and unpredictability on subject matter eligibility. It is now clear that our recent guidelines mark a significant step in that direction, and I ask all involved in our treasured patent system to come together and solve, once and for all, this fundamental issue.”

U.S. Army Receives Remdesivir at No Cost

Back in March, the U.S. Army signed a deal with Gilead Sciences to receive Remdesivir at no cost to treat Covid-19.  This is especially important given the recent study demonstrating Remdesivir as a potential effective treatment for Covid-19.  The Military Times discusses the deal as well as work on a vaccine which started in January, here.  

Relecura Offers Platform for Coronavirus Innovation and Patent Research for Free

Patent and innovation analytics firm, Relecura, is offering its platform for Coronavirus research for free for a period of time.  Here is a description of its platform:

Relecura Enterprise Platform

Derive smarter insights and power your decisions throughout the innovation life-cycle with Relecura’s Enterprise-wide customizable Platform

How do you manage complex data across various units and functions and use it to propel your business interests? Relecura Enterprise Platform helps you customize and automate workflows, combine data from a number of resources, quickly extract insights from it and collaborate across teams and functions to multiply the impact. Obtain powerful analytics and attain scale across the enterprise with a single platform. 

The offer is available, here.